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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06294912
Registration number
NCT06294912
Ethics application status
Date submitted
28/02/2024
Date registered
6/03/2024
Titles & IDs
Public title
A Study to Evaluate Antimalarial Activity and Safety of MK-7602 in Healthy Adults (MK-7602-003)
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Scientific title
A Controlled Human Malaria Infection Study to Evaluate the Antimalarial Activity of MK-7602 Against Plasmodium Falciparum Blood Stage Infection in Healthy Adult Participants
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Secondary ID [1]
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MK-7602-003
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Secondary ID [2]
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7602-003
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Malaria
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Condition category
Condition code
Infection
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Other infectious diseases
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Infection
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Plasmodium falciparum
Treatment: Drugs - MK-7602
Treatment: Drugs - Artemether/lumefantrine
Treatment: Drugs - Primaquine
Treatment: Drugs - Artesunate
Treatment: Drugs - Atovaquone/proguanil
Experimental: Panel A: MK-7602 Single dose Part 1 - Participants are inoculated with Plasmodium falciparum (P. falciparum). Panel A participants receive MK-7602 as a single oral dose. Participants will receive artemether/lumefantrine oral tablets as definitive antimalarial treatment. Additional definitive antimalarial treatment may be administered at the investigator's discretion.
Experimental: Panel B: MK-7602 Single dose Part 1 - Participants are inoculated with P. falciparum. Panel B participants receive MK-7602 as a single oral dose. Participants will receive artemether/lumefantrine oral tablets as definitive antimalarial treatment. Additional definitive antimalarial treatment may be administered at the investigator's discretion.
Experimental: Panel C: MK-7602 Single dose Part 1 - Participants are inoculated with P. falciparum. Panel C participants receive MK-7602 as a single oral dose. Participants will receive artemether/lumefantrine oral tablets as definitive antimalarial treatment. Additional definitive antimalarial treatment may be administered at the investigator's discretion.
Experimental: Panel D: MK-7602 Single dose Part 1 - Participants are inoculated with P. falciparum. Panel D participants receive MK-7602 as a single oral dose. Participants will receive artemether/lumefantrine oral tablets as definitive antimalarial treatment. Additional definitive antimalarial treatment may be administered at the investigator's discretion.
Experimental: Panel E: MK-7602 Single dose Part 1 - Participants are inoculated with P. falciparum. Panel E participants receive MK-7602 as a single oral dose. Participants will receive artemether/lumefantrine oral tablets as definitive antimalarial treatment. Additional definitive antimalarial treatment may be administered at the investigator's discretion.
Experimental: Panel F: MK-7602 Multiple dose Part 2 - Participants are inoculated with P. falciparum. Panel F participants receive MK-7602 at multiple oral doses. Participants will receive artemether/lumefantrine oral tablets as definitive antimalarial treatment. Additional definitive antimalarial treatment may be administered at the investigator's discretion.
Experimental: Panel G: MK-7602 Multiple dose Part 2 - Participants are inoculated with P. falciparum. Panel G participants receive MK-7602 at multiple oral doses. Participants will receive artemether/lumefantrine oral tablets as definitive antimalarial treatment. Additional definitive antimalarial treatment may be administered at the investigator's discretion.
Experimental: Panel H: MK-7602 Multiple dose Part 2 - Participants are inoculated with P. falciparum. Panel H participants receive MK-7602 at multiple oral doses. Participants will receive artemether/lumefantrine oral tablets as definitive antimalarial treatment. Additional definitive antimalarial treatment may be administered at the investigator's discretion.
Other interventions: Plasmodium falciparum
Parasite inoculation administered by intravenous (IV) infusion as the challenge agent
Treatment: Drugs: MK-7602
Capsules to be administered orally.
Treatment: Drugs: Artemether/lumefantrine
Tablets to be administered orally as definitive antimalarial treatment.
Treatment: Drugs: Primaquine
Tablets to be administered orally as definitive antimalarial treatment.
Treatment: Drugs: Artesunate
Intravenous (IV) infusion to be administered as definitive antimalarial treatment.
Treatment: Drugs: Atovaquone/proguanil
Tablets to be administered orally as definitive antimalarial treatment.
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Parasite reduction ratio (PRR48) (Parts 1 and 2)
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Assessment method [1]
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PRR48 is the logarithm of the parasite reduction ratio per 48 hours determined from parasitemia data from time 0 to time 48 hours. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the PRR48.
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Timepoint [1]
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Pre-inoculation on Day 0, once daily Days 4 to 7, pre-dose of MK-7602 on Day 8, post-first dose of MK-7602 at 2, 4, 8, 12, 16, 24, 30, 36, 48, 54, 60, 72, (78 Part 2 only), 84, and 96 hours, and once daily Days 13, 15, 17, 20, 22, 24, 27, 29, 31, and 34
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Primary outcome [2]
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Parasite Clearance Half-life (PCt1/2) (Parts 1 and 2)
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Assessment method [2]
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PCt1/2 is the half-life of the log-linear portion of the parasite clearance curve. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the PCt1/2.
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Timepoint [2]
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Pre-inoculation on Day 0, once daily Days 4 to 7, pre-dose of MK-7602 on Day 8, post-first dose of MK-7602 at 2, 4, 8, 12, 16, 24, 30, 36, 48, 54, 60, 72, (78 Part 2 only), 84, and 96 hours, and once daily Days 13, 15, 17, 20, 22, 24, 27, 29, 31, and 34
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Primary outcome [3]
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Parasite Regrowth (Parts 1 and 2)
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Assessment method [3]
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Parasite regrowth is defined as initial parasite clearance followed by asexual parasite regrowth above 5,000 parasites/mL. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the parasite regrowth.
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Timepoint [3]
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Pre-inoculation on Day 0, once daily Days 4 to 7, pre-dose of MK-7602 on Day 8, post-first dose of MK-7602 at 2, 4, 8, 12, 16, 24, 30, 36, 48, 54, 60, 72, (78 Part 2 only), 84, and 96 hours, and once daily Days 13, 15, 17, 20, 22, 24, 27, 29, 31, and 34
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Primary outcome [4]
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Part 1 Single dose: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of MK-7602
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Assessment method [4]
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Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the AUC0-inf for Part 1.
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Timepoint [4]
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Pre-dose of MK-7602 on Day 8 and post-dose of MK-7602 at 0.5, 1, 2, 3, 4, 8, 12, 24, 30, 36, 48, 54, 60, 72 and 96 hours and then once daily on Days 13, 15, 17, 20, and 22
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Primary outcome [5]
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Part 1 Single dose: Maximum Plasma Concentration (Cmax) of MK-7602
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Assessment method [5]
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Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the Cmax for Part 1.
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Timepoint [5]
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Pre-dose of MK-7602 on Day 8 and post-dose of MK-7602 at 0.5, 1, 2, 3, 4, 8, 12, 24, 30, 36, 48, 54, 60, 72 and 96 hours and then once daily on Days 13, 15, 17, 20, and 22
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Primary outcome [6]
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Part 1 Single dose: Concentration at 24 Hours (C24) of MK-7602
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Assessment method [6]
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Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the C24 for Part 1.
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Timepoint [6]
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Pre-dose of MK-7602 on Day 8 and post-dose of MK-7602 at 0.5, 1, 2, 3, 4, 8, 12, 24, 30, 36, 48, 54, 60, 72 and 96 hours and then once daily on Days 13, 15, 17, 20, and 22
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Primary outcome [7]
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Part 1 Single dose: Time to Maximum Plasma Concentration (Tmax) of MK-7602
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Assessment method [7]
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Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the Tmax for Part 1.
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Timepoint [7]
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Pre-dose of MK-7602 on Day 8 and post-dose of MK-7602 at 0.5, 1, 2, 3, 4, 8, 12, 24, 30, 36, 48, 54, 60, 72 and 96 hours and then once daily on Days 13, 15, 17, 20, and 22
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Primary outcome [8]
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Part 1 Single dose: Elimination Half-life (t1/2) of MK-7602
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Assessment method [8]
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Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the t1/2 for Part 1.
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Timepoint [8]
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Pre-dose of MK-7602 on Day 8 and post-dose of MK-7602 at 0.5, 1, 2, 3, 4, 8, 12, 24, 30, 36, 48, 54, 60, 72 and 96 hours and then once daily on Days 13, 15, 17, 20, and 22
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Primary outcome [9]
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Part 2 Multiple dose: Area Under the Curve Time 0 to End of the Dosing Interval (AUC0-tau) of MK-7602
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Assessment method [9]
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Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the AUC0-tau for Part 2.
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Timepoint [9]
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Pre-dose of MK-7602 on Day 8 and post-first dose of MK-7602 at 0.5, 1, 2, 3, 4, 8, 12, 24, 30, 36, 48, 54, 60, 72, 78, 84 and 96 hours and then once daily on Days 13, 15, 17, 20, and 22
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Primary outcome [10]
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Part 2 Multiple dose: Maximum Plasma Concentration (Cmax) of MK-7602
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Assessment method [10]
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Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the Cmax for Part 2.
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Timepoint [10]
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Pre-dose of MK-7602 on Day 8 and post-first dose of MK-7602 at 0.5, 1, 2, 3, 4, 8, 12, 24, 30, 36, 48, 54, 60, 72, 78, 84 and 96 hours and then once daily on Days 13, 15, 17, 20, and 22
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Primary outcome [11]
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Part 2 Multiple dose: Time to Maximum Plasma Concentration (Tmax) of MK-7602
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Assessment method [11]
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Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the Tmax for Part 2.
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Timepoint [11]
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Pre-dose of MK-7602 on Day 8 and post-first dose of MK-7602 at 0.5, 1, 2, 3, 4, 8, 12, 24, 30, 36, 48, 54, 60, 72, 78, 84 and 96 hours and then once daily on Days 13, 15, 17, 20, and 22
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Primary outcome [12]
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Part 2 Multiple dose: Elimination Half-life (t1/2) of MK-7602
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Assessment method [12]
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Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the t½ for Part 2.
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Timepoint [12]
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Pre-dose of MK-7602 on Day 8 and post-first dose of MK-7602 at 0.5, 1, 2, 3, 4, 8, 12, 24, 30, 36, 48, 54, 60, 72, 78, 84 and 96 hours and then once daily on Days 13, 15, 17, 20, and 22
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Secondary outcome [1]
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Number of Participants Who Experience an Adverse Event (AE)
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Assessment method [1]
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An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality.
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Timepoint [1]
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Up to Day 45
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Secondary outcome [2]
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Number of Participants Who Discontinue Study Intervention Due to an AE
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Assessment method [2]
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An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality.
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Timepoint [2]
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Up to Day 13
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Eligibility
Key inclusion criteria
The main inclusion and exclusion criteria include but are not limited to the following:
* Is in good health
* Has a body mass index (BMI) between 18 and 32 kg/m2, inclusive
* For participant assigned male sex at birth: If capable of producing sperm, participant must agree to the following during the study treatment period and for at least 90 days after the last dose of MK-7602: Refrain from donating sperm, plus EITHER be abstinent OR must agree to use male condom plus additional contraceptive method
* For participant assigned female sex at birth: EITHER be a person of nonchildbearing potential (PONCBP) OR must use a highly effective contraceptive method or be abstinent during the intervention period and for at least 10 days after the last dose of study intervention
* Must provide confirmation of not living alone (at any stage from inoculation day until the end of the study). A participant who lives alone may be included on a case-by-case basis.
* Agrees to refrain from eating food containing poppy seeds for 48 hours prior to screening, malaria inoculation, and MK-7602 administration
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* History of clinically significant clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* Is mentally or legally incapacitated or has a history of clinically significant psychiatric disorder
* History of cancer (malignancy)
* History of malaria
* History of splenectomy
* History of ever receiving a blood transfusion
* History of recurrent headache (eg, tension-type, cluster or migraine) with a frequency of =2 episodes per month on average and severe enough to require medical therapy, during the 5 years preceding the screening visit
* History of convulsion (including intravenous drug or vaccine-induced episodes). A medical history of a single febrile convulsion during childhood is not considered an exclusion criterion.
* Has presence of clinically significant infectious disease or fever (eg, sublingual temperature =38.5 degrees Celsius) within the 5 days prior to inoculation
* Has evidence of acute illness within the 4 weeks prior to screening that the Investigator deems may compromise participant safety
* Has clinically significant disease or any condition or disease that might affect drug absorption, distribution, or excretion (eg, gastrectomy, diarrhea)
* Has a medical requirement for intravenous immunoglobulin or blood transfusions
* Has had a major surgery with more than 470 mL of blood loss, lost 1 unit of blood (approximately 470 mL) or undergone blood donation of any volume to the Australian Red Cross Blood Service (Blood Service) or other blood blank within 4 weeks prior to the prestudy screening visit) or during the 8 weeks prior to inoculation
* Has used any corticosteroids, anti-inflammatory drugs (excluding commonly used over-the-counter anti-inflammatory drugs such as ibuprofen, acetylsalicylic acid, diclofenac), immunomodulators or anticoagulants within the past three months
* History of receiving immunosuppressive therapy (including systemic steroids, adrenocorticotrophic hormone, or inhaled steroids) at a dose or duration potentially associated with hypothalamic-pituitary-adrenal axis suppression within the past year from the screening visit
* Has had any vaccination within the last 28 days
* Has participated in another investigational study within 12 weeks (or 5 half-lives, whichever is greater) prior to the prestudy (screening) visit
* History of participation in a previous malaria challenge study or malaria vaccine study.
* Must not have had malaria exposure that is considered by the principal investigator or their delegate to be significant
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/04/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
24/03/2025
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Actual
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Sample size
Target
42
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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USC Clinical Trials Brisbane (South Bank) ( Site 0001) - South Brisbane
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Recruitment postcode(s) [1]
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4101 - South Brisbane
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Merck Sharp & Dohme LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to assess the antimalarial activity, pharmacokinetics, and safety of MK-7602 in healthy adults following Plasmodium falciparum (P. falciparum) infection.
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Trial website
https://clinicaltrials.gov/study/NCT06294912
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Merck Sharp & Dohme LLC
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Toll Free Number
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Address
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Country
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Phone
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1-888-577-8839
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06294912