NCT01525212

Multiple Ascending Dose Study of BMS-929075 in Hepatitis C Virus (HCV) Infected Patients

Double-Blinded, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Antiviral Activity, Safety, Tolerability, and Pharmacokinetics of BMS-929075 in Treatment Naive Subjects Infected With Hepatitis C Virus Genotype 1

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the change from baseline in HCV Ribonucleic acid (RNA) on Day 4 following three days of dosing with BMS-929075 in chronically genotype subtype 1a and 1b HCV infected subjects

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	BMS-929075	Oral Suspension, ≤ 25 mg, Once daily, 3 days
DRUG	BMS-929075	Oral Suspension, ≤ 100 mg, Once daily, 3 days
DRUG	BMS-929075	Oral Suspension, ≤ 400 mg, Once daily, 3 days
DRUG	BMS-929075	Oral Suspension, (≤ 800 mg, Once daily) OR (≤ 400 mg, Twice daily), 3 days
DRUG	Placebo matching BMS-929075	Oral Suspension, 0 mg, Once daily, 3 days
DRUG	Placebo matching BMS-929075	Oral Suspension, 0 mg, (Once daily for ≤ 800 mg group) OR (Twice daily for ≤ 400 mg group), 3 days

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2012-02-02
• Last updated: 2013-06-21

Locations

3 sites across 1 country: Australia