NCT00401947

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ACH-0137171 in Participants With Chronic Hepatitis C Infection

A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Multiple Doses of ACH-0137171 in Subjects With Chronic Hepatitis C Infection

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to investigate the safety, tolerability, pharmacokinetics (PK), and antiviral activity of multiple doses of ACH-0137171 in participants with chronic hepatitis C virus (HCV) infection.

Detailed description

This was a randomized, double-blind, placebo-controlled, dose-escalation study of ACH-0137171 in participants with chronic HCV infection. Sequential cohorts of 10 participants were randomized (8:2) to receive multiple doses of ACH-0137171 or placebo for 4 days (Days 1 through 4) with a single dose on Day 5 followed by a complete PK profile. Dosing was 300-600 milligrams (mg) administered either every 12 hours or every 6 hours (maximum daily dose of 2400 mg). All doses were administered with food. The dose cohorts were as follows: Study Schema: Cohort 1: 300 mg ACH-0137171/placebo every 12 hours (600 mg/day) Cohort 2: 300 mg ACH-0137171/placebo every 6 hours (1200 mg/day) Cohort 3: 600 mg ACH-0137171/placebo every 6 hours (2400 mg/day) A full review of all safety data will occur following each cohort. Depending on the data, the Sponsor, in consultation with the Principal Investigator(s), may consider modifying the planned dose escalation. The Sponsor may choose to interject an intermediate dose cohort between 2 planned dose escalations or repeat a given dose level, or extend the dosing period, or add an additional cohort. If a similar Grade 3 or 4 adverse event occurs in 3 or more participants and was considered to be at least possibly related to the study drug, escalation to a higher dose will not occur. Serial HCV ribonucleic acid (RNA) measurements, PK measurements of plasma concentrations of ACH-0137171, and periodic safety monitoring occurred on Days 1 through 5. Additional HCV RNA and PK measurements were taken on Days 6 through 9. Follow-up safety evaluations will be completed 14 days after the last study drug administration (that is, on Days 12 and 19).

Conditions

• HCV Infection

Interventions

Type	Name	Description
DRUG	ACH-0137171

Timeline

• Start date: 2006-11-30
• Completion: 2007-03-31
• First posted: 2006-11-22
• Last updated: 2022-09-15

Locations

9 sites across 3 countries: United States, Germany, Netherlands