NCT04314206
Completed
Phase 1
A Randomized, Double-Blind, Placebo-Controlled, Sequential Group, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Single and Repeat Doses of VNRX-5024 Administered Orally for 10 Days in Healthy Adult Volunteers
ConditionsHealthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- VNRX-5024
- Conditions
- Healthy Subjects
- Sponsor
- Basilea Pharmaceutica
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Number of subjects with adverse events
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief Summary
This is a 2-part dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-5024. Subjects will be enrolled in one of three dose cohorts. They will receive a single dose on Day 1 in Part 1 and will proceed into the multiple dose Part 2 of the study after safety assessments and PK samples are collected. In the multiple dose part of the study, subjects will receive multiple doses of VNRX-5024 for 10 days.
Investigators
Eligibility Criteria
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
- •Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder
- •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
Arms & Interventions
VNRX-5024
Capsule formulation
Intervention: VNRX-5024
Placebo
Placebo for VNRX-5024
Intervention: Placebo for VNRX-5024
Outcomes
Primary Outcomes
Number of subjects with adverse events
Time Frame: Day 19
Secondary Outcomes
- Part 1: Cmax(Days 1-2)
- Part 2: Cmax(Days 3-12)
- Part 1: tmax(Days 1-2)
- Part 2: tmax(Days 3-12)
- Part 1: CLr(Days 1-2)
- Part 2: CLr(Days 3-12)
- Part 1: AUC0-tau(Days 1-2)
- Part 2: AUC0-tau(Days 3-12)
Study Sites (1)
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