VNRX-5133 Drug-Drug Interaction in Healthy Adult Volunteers
Phase 1
Completed
- Conditions
- Bacterial Infections
- Interventions
- Registration Number
- NCT03332732
- Lead Sponsor
- Venatorx Pharmaceuticals, Inc.
- Brief Summary
This is a 2-part, drug-drug interaction study to evaluate potential PK interactions after single doses in Part 1 and multiple doses in Part 2. In Part 1, subjects will receive single dose of 5 treatments in a cross-over design; in Part 2 subjects will receive treatment for 10 days.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
- Healthy adults
- Males or non-pregnant, non-lactating females
- Body Mass Index (BMI) between 18.5 - 32.0, inclusive
- Weight greater than or equal to 50 kg
- Suitable veins for cannulation
Exclusion Criteria
- Employee of site or the sponsor
- Any disease that poses an unacceptable risk to participants
- Abnormal ECG
- Abnormal labs
- Abnormal vital signs
- Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder
- Positive serology for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) type 1
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 2 - 2B VNRX-5022 Multiple dose administration of High Dose VNRX-5133 + VNRX-5022 Part 1B VNRX-5133 In part 1B, subjects from Part 1A will receive metronidazole with or without VNRX-5133 + VNRX-5022. All subjects will receive all treatments in the sequence specified by the randomization schedule. Part 1A VNRX-5133 In Part 1A, subjects will receive single doses of VNRX-5133 and VNRX-5022 alone and in combination. All subjects will receive all treatments in the sequence specified by the randomization schedule.. Part 1A VNRX-5022 In Part 1A, subjects will receive single doses of VNRX-5133 and VNRX-5022 alone and in combination. All subjects will receive all treatments in the sequence specified by the randomization schedule.. Part 1B VNRX-5022 In part 1B, subjects from Part 1A will receive metronidazole with or without VNRX-5133 + VNRX-5022. All subjects will receive all treatments in the sequence specified by the randomization schedule. Part 1B Metronidazole In part 1B, subjects from Part 1A will receive metronidazole with or without VNRX-5133 + VNRX-5022. All subjects will receive all treatments in the sequence specified by the randomization schedule. Part 2 - 2C Placebo Multiple dose administration of Placebo (matching VNRX-5133 + VNRX-5022) Part 2 - 2A VNRX-5133 Multiple dose administration of Low Dose VNRX-5133 + VNRX-5022 Part 2 - 2A VNRX-5022 Multiple dose administration of Low Dose VNRX-5133 + VNRX-5022 Part 2 - 2B VNRX-5133 Multiple dose administration of High Dose VNRX-5133 + VNRX-5022
- Primary Outcome Measures
Name Time Method Peak Plasma Concentration (Cmax) of VNRX-5133 and VNRX-5022 following single doses alone and in combination (Part 1A) 0-48 hours Cmax
Area under the plasma concentration versus time curve (AUC) of VNRX-5133 and VNRX-5022 following single doses alone and in combination (Part 1A) 0-48 hours AUCinf
- Secondary Outcome Measures
Name Time Method Area under the plasma concentration versus time curve (AUC) of metronidazole, VNRX-5133, and VNRX-5022 (Part 1B) 0-48 hours AUCinf
Number of Subjects with Treatment Emergent Adverse Events First dose to 7 days after last dose: Part 1: 20 days / Part 2: 17 days TEAEs based on patient reporting, physical exams, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis.
Accumulation of VNRX-5133 + VNRX-5022 following multiple dose administration Part 2: 10 days Trough concentration levels from Day 1 - Day 10
Peak Plasma Concentration (Cmax) of metronidazole, VNRX-5133, and VNRX-5022 (Part 1B) 0-48 hours Cmax
Trial Locations
- Locations (1)
PRAHS
🇺🇸Lenexa, Kansas, United States