VNRX-7145 Drug-Drug Interaction in Healthy Adult Volunteers
Phase 1
Completed
- Conditions
- Healthy Subjects
- Interventions
- Registration Number
- NCT04877379
- Lead Sponsor
- Venatorx Pharmaceuticals, Inc.
- Brief Summary
This study will provide an initial assessment of the safety and PK of VNRX-7145 and VNRX-5024 (ceftibuten) when administered as single agents and with co-administration in a single dose cross-over design in Part 1. In Part 2, subjects will receive 500 mg of VNRX-7145 or matching placebo q8h for 10 days. VNRX-7145 and VNRX-5024 (ceftibuten) will be administered every 8 hours (q8h) for 10 days at 2 dose levels of VNRX-7145 in Part 3.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
Inclusion Criteria
- Healthy adults 18-55 years
- Males or non-pregnant, non-lactating females
- Body mass index (BMI): ≥18.5 kg/m2 and ≤32.0 kg/m2
- Normal blood pressure
- Normal lab tests
Exclusion Criteria
- History or presence of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorders
- History of drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug
- Use of antacid medications
- Abnormal ECG or history of clinically significant abnormal rhythm disorder
- Positive alcohol, drug, or tobacco use/test
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 3B VNRX-5024 (ceftibuten) Multiple dose administration of high dose VNRX-7145 + VNRX-5024 Part 3C Placebo Multiple dose administration of Placebo (matching VNRX-7145 + VNRX-5024) Part 1 VNRX-5024 (ceftibuten) Subjects will receive single doses of VNRX-7145 or VNRX-5024 alone and in combination. All subjects will receive study drug in the sequence specified by the randomization schedule. Part 3A VNRX-5024 (ceftibuten) Multiple dose administration of low dose VNRX-7145 + VNRX-5024 Part 1 VNRX-7145 Subjects will receive single doses of VNRX-7145 or VNRX-5024 alone and in combination. All subjects will receive study drug in the sequence specified by the randomization schedule. Part 2B Placebo Multiple dose administration of placebo q8h for 10 days Part 2A VNRX-7145 Multiple dose administration of VNRX-7145 q8h for 10 days Part 3A VNRX-7145 Multiple dose administration of low dose VNRX-7145 + VNRX-5024 Part 3B VNRX-7145 Multiple dose administration of high dose VNRX-7145 + VNRX-5024
- Primary Outcome Measures
Name Time Method Part 1: AUC0-inf 0-48 hours Area under the concentration-time curve from time-zero extrapolated to infinity based on collected PK
Parts 2&3: Number of subjects with adverse events Day 15 (+2) Part 1: Cmax 0-48 hours concentration time data
- Secondary Outcome Measures
Name Time Method Parts 2&3: AUC0-tau Day 10 Parts 2&3: Cmax Day 10 Part 1: Number of subjects with adverse events Day 14 (+2)
Trial Locations
- Locations (1)
PRA Health Sciences - Early Development Services
🇳🇱Groningen, Netherlands