drugset
drugset / Trial / NCT03032536

Study of the Relative Oral Bioavailability of AL-3778 Tablets and Drug Interaction With Entecavir or Tenofovir Disoproxil Fumarate in Healthy Volunteers

NCT03032536 ↗

Phase 1 Terminated 54 enrolled Alios Biopharma Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label, randomized, multi-part study to evaluate the relative oral bioavailability of a tablet formulation of AL-3778 (formerly NVR 3-778) administered under fasted and fed conditions (Parts 1 and 2) and the drug-drug interaction between AL-3778 and entecavir or tenofovir disoproxil fumarate (Part 3).

Timeline

Start
2017-01-31
Primary completion
2017-06-28
Completion
2017-06-28

Drugs

EvaluationDrugModalityDoseRoute
Subject AL-3778 Unknown 600 mg Oral
Subject AL-3778 Unknown 700 mg Oral
Subject AL-3778 Unknown 800 mg Oral
Subject AL-3778 Unknown 1000 mg Oral
Subject Entecavir Small molecule 0.5 mg —
Subject Tenofovir disoproxil fumarate Small molecule 300 mg —

Indications

chronic hepatitis B virus infection