NCT02512562

A Study to Evaluate the Effect of ACH-3102 and Simeprevir on AL-335 Pharmacokinetics in Healthy Volunteers

A Phase-1, Open-label, Two Group, Fixed-Sequence Study to Evaluate the Effect of ACH-3102 and Simeprevir on AL-335 Pharmacokinetics in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Alios Biopharma Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, two-group, fixed-sequence study to evaluate the effect of ACH-3102 and Simeprevir on AL-335 pharmacokinetics in healthy volunteers.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	AL-335	AL-335 is a prodrug being developed as an orally administered anti-HCV therapeutic.
DRUG	ACH-3102	ACH-3102 is an NS5A inhibitor being developed as an orally administered anti-HCV therapeutic.
DRUG	Simeprevir	Simeprevir is an orally active, small molecule inhibitor of the NS3/4A protease of HCV and indicated for the treatment of chronic HCV infection as a component of a combination antiviral treatment regimen.

Timeline

• Start date: 2015-07-31
• Primary completion: 2015-08-31
• Completion: 2015-08-31
• First posted: 2015-07-31
• Last updated: 2019-10-16

Locations

1 site across 1 country: France