A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Entecavir Extended Release (XR) in Healthy Subjects
- Registration Number
- NCT03239353
- Lead Sponsor
- Aucta Pharmaceuticals, Inc
- Brief Summary
This is a phase 1, randomized, parallel-group, single-center study in healthy adult subjects. The study will be conducted in two parts sequentially:
Part 1 is an open-label, two-arm, active-controlled design to evaluate the PK and safety of single oral dose of ETV XR tablet (1.5 mg) in healthy subjects. Part 1 will consist of 16 healthy subjects.
Part 2 is a double-blind, three-arm, placebo-controlled design to evaluate the PK and safety of higher oral doses of ETV XR tablet (3 mg and 6 mg) in healthy subjects. Part 2 will consist of 24 healthy subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 mg ETV XR tablet Entecavir - 6 mg ETV XR tablet Entecavir - 1.5 mg ETV XR tablet Entecavir - Placebo-to-match 1.5 mg ETV XR tablet Entecavir - 0.5 mg ETV IR tablet Entecavir -
- Primary Outcome Measures
Name Time Method To characterize the Pharmacokinetics (PK) of ETV XR tablet after single oral doses in healthy subjects. 22 days Peak Plasma Concentration(Cmax)
To characterize the Pharmacokinetics (PK) of ETV XR tablet after single oral doses 22 days half life (t1/2)
- Secondary Outcome Measures
Name Time Method To assess ETV XR tablet in healthy subjects. 22 days 12-lead electrocardiograms (ECGs)
To evaluate the dose linearity of ETV XR tablet 60 days 1.5mg, 3mg and 6mg PK linearity
Trial Locations
- Locations (1)
Linear Clinical Research Ltd
π¦πΊNedlands, Western Australia, Australia