P1, DDI & MAD PK and Safety Study of Xeruborbactam Oral Prodrug in Combo With Ceftibuten in Healthy Participants
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.
Study details:
Qpex Biopharma, Inc. is developing an oral dosage form that delivers Xeruborbactam, a new boron-based beta-lactamase inhibitor with activity against both serine and metallo-beta-lactamases, for oral treatment in combination with a beta-lactam antibiotic. Ceftibuten is a cephalosporin antibiotic approved in the US for acute exacerbations of chronic bronchitis, acute bacterial otitis media and pharyngitis/tonsillitis.
This Phase 1 study will assess if a PK interaction exists between xeruborbactam oral prodrug and ceftibuten when given in combination at doses of each drug that have previously been shown to be safe. The study will also assess the safety of the combination with dosing over 10 days. Study Objectives:.
1. To assess the safety, tolerability, and PK of single and multiple doses of xeruborbactam oral prodrug and ceftibuten both in combination and alone, in healthy adult participants. 2.
To assess whether there is any PK interaction between xeruborbactam oral prodrug and ceftibuten when administered in combination to healthy adult participants.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- Participant must be a healthy adult male or female, 18 to 55 years of age (inclusive) at the time of screening.
- 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.
- Body mass index (BMI) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive).
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- If male, agree to be sexually abstinent or agree to use 2 approved methods of contraception 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.
- 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.
- 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.
Exclusion criteria
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- 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.
- Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- Females who are pregnant or lactating.
- Surgery within the past 3 months prior to Day 1 determined by the investigator, sub-investigator, or medical officer to be clinically relevant.
- Any acute illness within 30 days prior to Day 1.
- 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.
- Use of any prescription medication (with the exception of hormonal contraceptives or hormone replacement therapy for females) within 14 days prior to Day 1.
- Use of any over-the-counter medication, including herbal products, probiotics and vitamins, within the 7 days prior to Day 1.
- Use of antacids, H2 receptor blockers or proton pump inhibitors 7 days prior to Day 1.
- 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.
- 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).
- Calculated creatinine clearance < 80 mL/min (Cockcroft-Gault method) at screening or check-in (Day -1).
- Any clinically significant abnormalities in laboratory values at screening or check-in (Day -1).
- Blood donation or significant blood loss (ie, > 500 mL) within 56 days prior to Day 1.
- Plasma donation within 7 days prior to Day 1.
- Positive urine drug/alcohol testing at screening or check-in (Day -1).
- History or presence of alcoholism or drug abuse within the 2 years prior to Day 1.
- Use of more than 5 packs/week of cigarettes (or equivalent amount of nicotine-containing product) within 6 months prior to Day 1.
- Excessive intake of alcohol, defined as an average daily intake of > 2 standard drinks for women and > 4 standard drinks for men.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE1
Study ID
NCT06079775
Intervention or treatment
DRUG: Xeruborbactam Oral Prodrug
DRUG: Ceftibuten
DRUG: Xeruborbactam Oral Prodrug Placebo
DRUG: Ceftibuten Placebo
Conditions
- Bacterial Infections
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Research sites nearby
Closest Location:
CMAX
Select from list below to view details:
CMAX
Adelaide, South Australia, Australia
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Who is running the clinical trial?
Qpex Biopharma, Inc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Single Dose Drug-Drug-Interaction Crossover & Multiple Dose Cohorts
| Drug: Xeruborbactam Oral Prodrug, Drug: Ceftibuten |
PLACEBO_COMPARATOR: Placebo Comparator to maintain the blind
| Drug: Xeruborbactam Oral Prodrug Placebo, Drug: Ceftibuten Placebo |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment -Emergent Adverse events by subject and by cohort (single dose, multiple doses) | Number of patients with Treatment-Emergent Adverse Events by subject, by cohort, severity and relationship to treatment | 16 days |
| Number of patients with changes from baseline in safety parameters | Number of patients with changes in safety parameters before and after dosing by subject and cohort | 16 days |
| Peak plasma Concentration measurements by subject and by cohort (Cmax) | Comparison will be performed between the cohorts for concentration measurements (Cmax). Mean graphical presentation of the data will be reported. Statistical analysis of exposure parameters will be performed. | 16 days |
| Time concentration data measurements by subject and by cohort (Tmax) | Comparison will be performed between the cohorts for time concentration data measurements (Tmax) | 16 days |
| Area under the plasma concentration versus time curve (AUC) between cohorts | Comparison will be performed between the cohorts for area under the plasma concentration versus time curve (AUC). Mean graphical presentation of the data will be reported. Statistical analysis of exposure parameters will be performed. | 16 days |
| Urine Pharmacokinetic (PK) amount excreted by subject and by cohort | Urine Pharmacokinetic (PK) parameters such as amount excreted will be calculated from urinary excretion data | 16 days |
| Urine Pharmacokinetic (PK) % dose excreted by subject and by cohort | Urine Pharmacokinetic (PK) parameters such as amount of % dose excreted will be calculated from urinary excretion data | 16 days |
Secondary Outcome
References
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