NCT03239353

A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Entecavir Extended Release (XR) in Healthy Subjects

A Phase 1, Randomized, Partially-Blind, Parallel-Group, Active and Placebo Controlled Study to Evaluate the Safety and Pharmacokinetics of Single Oral Doses of Entecavir Extended Release (XR) in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Aucta Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• HBV

Interventions

Type	Name	Description
DRUG	Entecavir	Study drug (entecavir or placebo) will be administered with 240 mL of water following an overnight fast (no food or drink, except water, for at least 10 hours). Subjects will be required to fast (no food or beverages other than water) until after collection of the 4-hour blood draw.

Timeline

• Start date: 2017-10-20
• Primary completion: 2018-05-29
• Completion: 2018-06-20
• First posted: 2017-08-04
• Last updated: 2018-06-27

Locations

1 site across 1 country: Australia