NCT03032536

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

A Randomized, Open-label, Multi-part Study of the Relative Oral Bioavailability of AL-3778 Tablets and Drug Interaction With Entecavir or Tenofovir Disoproxil Fumarate in Healthy Volunteers

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Alios Biopharma Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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).

Conditions

• Hepatitis B
• Chronic Hepatitis B
• Viral Hepatitis B

Interventions

Type	Name	Description
DRUG	AL-3778	AL-3778 tablets or capsules
DRUG	Entecavir	Entecavir once daily for 14 days
DRUG	Tenofovir disoproxil fumarate	Tenofovir disoproxil fumarate once daily for 14 days

Timeline

• Start date: 2017-01-31
• Primary completion: 2017-06-28
• Completion: 2017-06-28
• First posted: 2017-01-26
• Last updated: 2017-10-16

Locations

2 sites across 1 country: New Zealand

Regulatory

• FDA-regulated drug study