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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06079775




Registration number
NCT06079775
Ethics application status
Date submitted
6/10/2023
Date registered
12/10/2023

Titles & IDs
Public title
P1, DDI & MAD PK and Safety Study of Xeruborbactam Oral Prodrug in Combo With Ceftibuten in Healthy Participants
Scientific title
A Phase 1, Open-Label, Drug-drug Interaction, and Randomized, Double-blind, Controlled, Multiple-dose Pharmacokinetics and Safety Study of Xeruborbactam Oral Prodrug (QPX7831) in Combination With Ceftibuten in Healthy Adult Participants
Secondary ID [1] 0 0
Qpex-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bacterial Infections 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Xeruborbactam Oral Prodrug
Treatment: Drugs - Ceftibuten
Treatment: Drugs - Xeruborbactam Oral Prodrug Placebo
Treatment: Drugs - Ceftibuten Placebo

Experimental: Single Dose Drug-Drug-Interaction Crossover & Multiple Dose Cohorts - During the DDI crossover part of the study, 24 subjects will be enrolled into 3 cohorts of 8 subjects each, Cohorts 1, 2, \& 3 respectively.

All subjects in Cohorts 1, 2, and 3 will receive a single dose of xeruborbactam oral prodrug on Day 1. On Day 6, they will receive a single dose of ceftibuten. On Day 9 they will receive a single combined dose of xeruborbactam oral prodrug and ceftibuten.

During the MAD part of the study, 48 subjects will be enrolled into 3 cohorts of 16 subjects each, Cohorts 4, 5, \& 6 respectively.

All subjects in Cohorts 4, 5, and 6 will receive either a combined dose of xeruborbactam oral prodrug and ceftibuten, active ceftibuten, or active xeruborbactam oral prodrug.

Cohort 4 \& 5 will be dosed BID on Days 1 through 9, with last and final dose on the morning of Day 10.

Cohort 6 will be dosed BID on Day 1, and then QD on Days 2 through 10 with last dose on the morning of Day 10.

All subjects will be followed for safety and PK data collection.

Placebo comparator: Placebo Comparator to maintain the blind - During the multiple-dose portion of the study, Xeruborbactam Oral Prodrug Placebo and Ceftibuten placebo will be used to maintain the blind. In Cohorts 4, 5, and 6, ten (10) subjects in each cohort will receive a combined dose of xeruborbactam oral prodrug and ceftibuten. Three (3) subjects in each cohort will receive active ceftibuten capsules with xeruborbactam oral prodrug placebo capsules. Three (3) subjects in each cohort will receive active xeruborbactam oral prodrug capsules with ceftibuten placebo capsules.


Treatment: Drugs: Xeruborbactam Oral Prodrug
Experimental

Treatment: Drugs: Ceftibuten
Experimental

Treatment: Drugs: Xeruborbactam Oral Prodrug Placebo
Placebo Comparator

Treatment: Drugs: Ceftibuten Placebo
Placebo Comparator
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Treatment -Emergent Adverse events by subject and by cohort (single dose, multiple doses)
Timepoint [1] 0 0
16 days
Primary outcome [2] 0 0
Number of patients with changes from baseline in safety parameters
Timepoint [2] 0 0
16 days
Primary outcome [3] 0 0
Peak plasma Concentration measurements by subject and by cohort (Cmax)
Timepoint [3] 0 0
16 days
Primary outcome [4] 0 0
Time concentration data measurements by subject and by cohort (Tmax)
Timepoint [4] 0 0
16 days
Primary outcome [5] 0 0
Area under the plasma concentration versus time curve (AUC) between cohorts
Timepoint [5] 0 0
16 days
Primary outcome [6] 0 0
Urine Pharmacokinetic (PK) amount excreted by subject and by cohort
Timepoint [6] 0 0
16 days
Primary outcome [7] 0 0
Urine Pharmacokinetic (PK) % dose excreted by subject and by cohort
Timepoint [7] 0 0
16 days

Eligibility
Key inclusion criteria
Participants will be eligible to be included in the study only if all of the following criteria apply:

Age

1. Participant must be a healthy adult male or female, 18 to 55 years of age (inclusive) at the time of screening.

Type of Participant and Disease Characteristics
2. Participants who are overtly medically healthy with clinically insignificant screening results (eg, laboratory profiles, medical histories, ECGs, physical examination) as assessed by the investigator, sub-investigator, or medical officer.

Weight
3. Body mass index (BMI) = 18.5 and = 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive). Note: BMI = kg/m2 where kg is a weight in kilograms and m2 is a height in meters squared.

Sex and Contraceptive/Barrier Requirements
4. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Male participants:

If male, agree to be sexually abstinent or agree to use 2 approved methods of contraception (refer to inclusion criterion #5) when engaging in sexual activity from study check-in through 30 days following the last administration of the study drug, and to not donate sperm during this same period of time. If the sexual partner is surgically sterile, contraception is not necessary.
5. Female participants:

Females of childbearing potential must either be sexually abstinent for 14 days prior to Day 1 and agree to remain so through 30 days following the last administration of the study drug, OR have been using (or agree to use) 2 of the following acceptable methods of birth control for the times specified:
1. Intra-uterine device (IUD) in place for at least 3 months prior to Day 1 through 30 days following the final dosing of the study drug
2. Barrier method (condom or diaphragm) for at least 14 days prior to Day 1 through 30 days following the final dosing of the study drug
3. Stable hormonal contraceptive for at least 3 months prior to Day 1 and barrier method (condom or diaphragm) for at least 14 days prior to Day 1 through 30 days following final dosing of the study drug
4. Surgical sterilization (vasectomy) of partner at least 6 months prior to Day 1

Informed Consent
6. Capable of giving signed informed consent as described in Appendix 1 Informed Consent Form (Section 10.1.3) that includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded from the study if any of the following criteria apply:

Medical Conditions

1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
2. Documented hypersensitivity reaction or anaphylaxis to any medication, including ceftibuten or other beta-lactam antibiotics (e.g. cephalosporins, penicillins, carbapenems or monobactams) or any excipients used in this formulation.
3. Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
4. Females who are pregnant or lactating.
5. Surgery within the past 3 months prior to Day 1 determined by the investigator, sub-investigator, or medical officer to be clinically relevant.
6. Any acute illness within 30 days prior to Day 1.
7. Any other condition or prior therapy, which, in the opinion of the investigator, sub-investigator, or medical officer would make the participant unsuitable for this study.

Prior/Concomitant Therapy
8. Use of any prescription medication (with the exception of hormonal contraceptives or hormone replacement therapy for females) within 14 days prior to Day 1.
9. Use of any over-the-counter medication, including herbal products, probiotics and vitamins, within the 7 days prior to Day 1. Up to 2 grams per day of paracetamol is allowed for acute events at the discretion of the investigator, sub-investigator, or medical officer.
10. Use of antacids, H2 receptor blockers or proton pump inhibitors 7 days prior to Day 1. This includes calcium carbonate.

Prior/Concurrent Clinical Study Experience
11. Participation in another investigational clinical trial within 30 days prior to Day 1 or within 5 half-lives of the previous investigational drug, whichever is longer.

Diagnostic Assessments
12. QTc corrected according to Fridericia's formula (QTcF) interval > 450 msec for males and > 470 for females or history of prolonged QT syndrome at screening or check-in (Day -1).
13. Calculated creatinine clearance < 80 mL/min (Cockcroft-Gault method) at screening or check-in (Day -1).
14. Any clinically significant abnormalities in laboratory values at screening or check-in (Day -1), in particular:

1. White blood cell count < 3,000/mm3, hemoglobin < 11g/dL
2. Absolute neutrophil count < 1,200/mm3 or platelet count < 120,000/mm3
3. Liver function abnormalities at screening or check-in (Day -1) (defined by an elevation in bilirubin, AST, or ALT > ULN for participants based on age and sex)

Other Exclusion Criteria
15. Blood donation or significant blood loss (ie, > 500 mL) within 56 days prior to Day 1.
16. Plasma donation within 7 days prior to Day 1.
17. Positive urine drug/alcohol testing at screening or check-in (Day -1).
18. History or presence of alcoholism or drug abuse within the 2 years prior to Day 1.
19. Use of more than 5 packs/week of cigarettes (or equivalent amount of nicotine-containing product) within 6 months prior to Day 1. Use of all nicotine containing products 48 hours prior to admission to clinical research unit. Participants must agree to refrain from smoking for the duration of the study.
20. Excessive intake of alcohol, defined as an average daily intake of > 2 standard drinks for women and > 4 standard drinks for men, (standard drink is the equivalent to 4 oz of wine (approximately 12% abv), 12 oz of regular beer (approximately 5% abv), or 1.5 oz of spirits (80 proof).

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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
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
30/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
7/12/2024
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Qpex Biopharma, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Shionogi Inc.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Biomedical Advanced Research and Development Authority
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Jeff Loutit, MBChB
Address 0 0
Qpex Biopharma, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Shawnee Gehrke, MPH
Address 0 0
Country 0 0
Phone 0 0
(760) 419-7428
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/NCT06079775