P1, DDI & MAD PK and Safety Study of Xeruborbactam Oral Prodrug in Combo With Ceftibuten in Healt… (NCT06079775) | Clinical Trial Compass
CompletedPhase 1
P1, DDI & MAD PK and Safety Study of Xeruborbactam Oral Prodrug in Combo With Ceftibuten in Healthy Participants
Australia53 participantsStarted 2024-01-30
Plain-language summary
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
Who can participate
Age range18 Years – 55 Years
SexALL
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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). Note: BMI = kg/m2 where kg is a weight in kilograms and m2 is a height in meters squared.
✓. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
✓. Female participants:
✓. 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
✓. 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
✓. 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
Exclusion criteria
✕. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
What they're measuring
1
Incidence of Treatment -Emergent Adverse events by subject and by cohort (single dose, multiple doses)
Timeframe: 16 days
2
Number of patients with changes from baseline in safety parameters
Timeframe: 16 days
3
Peak plasma Concentration measurements by subject and by cohort (Cmax)
Timeframe: 16 days
4
Time concentration data measurements by subject and by cohort (Tmax)
Timeframe: 16 days
5
Area under the plasma concentration versus time curve (AUC) between cohorts
Timeframe: 16 days
6
Urine Pharmacokinetic (PK) amount excreted by subject and by cohort
Timeframe: 16 days
7
Urine Pharmacokinetic (PK) % dose excreted by subject and by cohort
. 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.