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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06213818




Registration number
NCT06213818
Ethics application status
Date submitted
10/01/2024
Date registered
19/01/2024

Titles & IDs
Public title
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of INCB160058 When Administered Orally to Healthy Adult Participant
Scientific title
A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single-Dose, Dose-Escalation, Drug-Interaction, and Food-Effect Study to Assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 When Administered Orally to Healthy Adult Participants
Secondary ID [1] 0 0
INCB160058-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Participants 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - INCB160058
Treatment: Drugs - Placebo
Treatment: Drugs - Esomeprazole

Experimental: Cohort 1: Dose - INCB160058 will be administered at protocol defined dose.

Experimental: Cohort 2: Dose - INCB160058 will be administered at protocol defined dose.

Experimental: Cohort 3: Dose - INCB160058 will be administered at protocol defined dose.

Experimental: Cohort 4: Dose - INCB160058 will be administered at protocol defined dose.

Experimental: Cohort 5: Dose - INCB160058 will be administered at protocol defined dose.

Experimental: Cohort 6: Dose Treatment A - INCB160058 will be administered at protocol defined dose after an overnight fast.

Experimental: Cohort 6: Dose Treatment B - INCB160058 will be administered at protocol defined dose after a high-fat-calorie meal.

Experimental: Cohort 7: Dose - INCB160058 and Esomeprazole will be administered at protocol defined schedule and dose.


Treatment: Drugs: INCB160058
Oral; Tablet

Treatment: Drugs: Placebo
Oral; Tablet

Treatment: Drugs: Esomeprazole
Oral; Capsule
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Up to Day 28
Primary outcome [2] 0 0
INCB160058 pharmacokinetic (PK) in Plasma
Timepoint [2] 0 0
Up to Day 5
Primary outcome [3] 0 0
INCB160058 pharmacokinetic (PK) in Plasma to determine the effect of food
Timepoint [3] 0 0
Up to Day 12
Primary outcome [4] 0 0
INCB160058 pharmacokinetic (PK) in Plasma to assess the effect of esomeprazole
Timepoint [4] 0 0
Up to Day 14
Secondary outcome [1] 0 0
Additional INCB160058 pharmacokinetic (PK) in Plasma
Timepoint [1] 0 0
Up to Day 14
Secondary outcome [2] 0 0
INCB160058 pharmacokinetic (PK) in Urine
Timepoint [2] 0 0
Up to Day 5

Eligibility
Key inclusion criteria
* Ability to comprehend and willingness to sign a written ICF for the study.
* Age 18 to 55 years, inclusive, at the time of signing the ICF.
* Body mass index between 18.0 and 32.0 kg/m2 (inclusive).
* Willingness to adhere to study-related prohibitions, restrictions, and procedures.
* Ability to swallow and retain oral medication.
* Willingness to avoid pregnancy or fathering children based on the criteria below.

* Male participants with reproductive potential must agree to use 1 of the highly effective methods of contraception to avoid fathering children from screening through the last follow-up visit and must refrain from donating sperm during this period. Permitted methods in preventing pregnancy should be communicated to the participants and their understanding confirmed.
* Female participants who are WOCBP must have a negative pregnancy test at screening and check-in, must agree to use 1 of the highly effective methods of contraception to avoid pregnancy from screening through the last follow-up visit, and must refrain from donating oocytes during this period.

Permitted methods in preventing pregnancy should be communicated to the participants and their understanding confirmed. Positive pregnancy tests may be confirmed at the investigator's discretion.

• Female participants not considered to be of childbearing potential are eligible and must have a negative pregnancy test at screening and check-in.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* History of uncontrolled or unstable cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening.
* History of rheumatologic/autoimmune disorders and immune deficiency/immunologic defects.
* Prior history of major bleeding or thrombosis, including myocardial infarction/stroke and pulmonary embolism/deep vein thrombosis.
* Known tuberculosis infection that is active or participant-reported history of tuberculosis or treatment thereof.
* Resting pulse < 40 bpm or > 100 bpm, confirmed by repeat testing at screening.
* History or presence of an abnormal ECG before initial dose administration that, in the investigator's opinion, is clinically significant (QTcF interval > 450 milliseconds, QRS interval > 120 milliseconds, and PR interval > 220 milliseconds).
* Presence of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn disease or chronic pancreatitis).
* Hemoglobin level, WBC count, platelet count, or absolute neutrophil count below the laboratory lower limit of normal at screening or at check-in, confirmed by repeat testing and clinically significant in the opinion of the investigator.
* Hepatic transaminase (ALT and AST), ALP, or total bilirubin levels > 1.25 × the laboratory-defined ULN at screening or at check-in, confirmed by repeat testing (except participants with Gilbert disease, for which total bilirubin must be = 2.0 × ULN).
* History of malignancy within 5 years of screening, with the exception of cured basal cell or squamous cell carcinoma of the skin, ductal carcinoma in situ, or prostate cancer.
* Current or recent (within 3 months of screening) clinically significant gastrointestinal disease or surgery (including cholecystectomy) that could affect the absorption of study drug, with the exception of appendectomy.
* Any major surgery within 12 weeks of screening.
* Donation of blood to a blood bank within 4 weeks of screening (within 2 weeks for plasma only).
* Blood transfusion within 4 weeks of check-in.
* Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.
* Positive test for hepatitis B virus, hepatitis C virus, or human immunodeficiency virus.

Note: Participants whose results are compatible with prior immunization or immunity due to infection for hepatitis B may be included at the discretion of the investigator.

* Regular alcohol consumption > 21 units per week (1 unit = ½ pint beer or a 25-mL shot of 40% spirit, 1.5 to 2 units = 125-mL glass of wine, depending on type).
* Positive urine or breath test for ethanol or positive urine or serum screen for drugs of abuse that are not otherwise explained by permitted concomitant medications or diet.
* Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug with another investigational medication or current enrollment in another investigational drug protocol.
* Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug with an inducer or inhibitor of CYP3A4, P-gp, or BCRP (refer to the Drug Interaction Database for prohibited drugs).
* History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) deemed clinically relevant by the investigator.
* Known hypersensitivity or severe reaction to INCB160058 or any excipients of INCB160058 (refer to the IB).
* Inability to undergo venipuncture or tolerate venous access.
* Inability or unlikeliness of the participant to comply with the dose schedule and study evaluations, in the opinion of the investigator.
* Use of tobacco- or nicotine-containing products within 1 month of screening.
* Use of prescription drugs (including oral, implantable, transdermal, injectable, intravaginal, or hormonal intrauterine contraceptives) or topical steroids within 14 days prior to study drug administration or nonprescription medications/products (including vitamins, minerals, and phytotherapeutic, herbal, or plant-derived preparations) within 7 days prior to study drug administration and during the study.

Note: Occasional use of acetaminophen (see Section 6.6.1) is permitted during the study.

* Women who are pregnant or breastfeeding.
* eGFR < 90 mL/min/1.73 m2 based on the Chronic Kidney Disease Epidemiology Collaboration formula.
* Any history of hypersensitivity or intolerance to esomeprazole or any other PPI.
* Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/09/2024
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
03004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Incyte Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Incyte Medical
Address 0 0
Incyte Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Incyte Corporation Call Center (US)
Address 0 0
Country 0 0
Phone 0 0
1.855.463.3463
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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/NCT06213818