Evaluation of the Safety, Tolerability, Pharmacokinetics, and Activity of GS-9450 in Subjects With Chronic HCV
NCT00725803 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2014-06-19
Summary
The purpose of this study is to examine the safety, tolerability, pharmacokinetics (studies how the body processes a drug), and initial activity of GS-9450 in preventing liver damage due to scarring, or fibrosis, caused by Hepatitis C Virus (HCV) infection.
Conditions
- HCV Infection
Interventions
- DRUG
-
GS-9450 Placebo
Placebo to match GS-9450 administered orally once daily
- DRUG
-
GS-9450
GS-9450 capsules administered orally once daily
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
David Oldach, MD · Gilead Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-04-30
- Primary Completion
- 2008-10-31
- Completion
- 2009-03-31
Countries
- United States
- Germany
- Netherlands
Study Locations
More Related Trials
-
A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-6620 in Treatment Naïve Subjects With Chronic Hepatitis C Virus Infection
NCT01316237 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, and Antiviral Activity of 24 or 48 Weeks of GS-9190 in Combination With Peginterferon Alfa 2a and Ribavirin for the Treatment of Genotype-1 Chronic HCV Infection
NCT00743795 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate the Pharmacokinetics and Safety of GSK2336805 in Subjects With Hepatic Impairment and Healthy Matched Control Subjects
NCT01827657 ·Status: COMPLETED ·Phase: PHASE1
-
A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis C
NCT01591668 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Response-Guided Duration of Combination Therapy With GS-9190, GS-9256, Pegasys® and Copegus® in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C
NCT01225380 ·Status: COMPLETED ·Phase: PHASE2
-
A First Time in Human Study to Assess GSK2336805 in Healthy Volunteers and Single Doses in Chronically Infected Hepatitis C Patients.
NCT01277692 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety Study of GS-9256 and GS-9190 Alone and in Combination With Ribavirin for 28 Days in Patients With Chronic Hepatitis C Virus Infection
NCT01072695 ·Status: COMPLETED ·Phase: PHASE2
-
Oral Antivirals (GS-5885, Tegobuvir, and/or GS-9451) With Peginterferon Alfa 2a and Ribavirin in Treatment Experienced Subjects With Chronic Genotype 1 Hepatitis C Virus Infection
NCT01371578 ·Status: COMPLETED ·Phase: PHASE2
-
A Single Ascending Dose Study of BMS-650032 in HCV Infected Subjects
NCT00559247 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of Repeat Doses of GSK2878175 in Subjects With Chronic Hepatitis C.
NCT02014571 ·Status: COMPLETED ·Phase: PHASE1
-
GS-5885, GS-9451 With Peginterferon Alfa 2a (PEG) and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 Hep C Virus Infection and IL28B CC Genotype
NCT01384383 ·Status: TERMINATED ·Phase: PHASE2
-
Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Voxilaprevir in Adults With Chronic Hepatitis C Virus Infection
NCT02185794 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1 Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
NCT01817985 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Velpatasvir in Participants With Chronic HCV Infection
NCT01740791 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of RO5428029 in Healthy Volunteers and Patients With Chronic Hepatitis C
NCT01371162 ·Status: COMPLETED ·Phase: PHASE1
-
A Multiple Ascending Dose Study of BMS-650032 in HCV Infected Subjects
NCT00722358 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-9669 in Subjects With Chronic Hepatitis C Virus Infection
NCT01431898 ·Status: COMPLETED ·Phase: PHASE1
-
Multiple Ascending Dose Study of BMS-929075 in Hepatitis C Virus (HCV) Infected Patients
NCT01525212 ·Status: WITHDRAWN ·Phase: PHASE1
-
Study in HCV-Infected Patients to Determine the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of JNJ-47910382
NCT01651767 ·Status: TERMINATED ·Phase: PHASE1
-
GS 5885 Administered Concomitantly With GS-9451, Tegobuvir and Ribavirin (RBV) in Chronic Genotype 1 Hepatitis C Virus (HCV) Infection
NCT01353248 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Hepatitis C Virus (HCV) Nonstructural Protein 5a (NS5A) Inhibitor IDX719 in Healthy and HCV-Infected Participants (MK-1894-001)
NCT01508156 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety, Antiviral Activity, and Pharmacokinetics of GSK2336805 With Peginterferon and Ribavirin in Chronic Hepatitis C Subjects
NCT01439373 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Chronic Hepatitis C Virus Infection Without Cirrhosis
NCT02114177 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase 1/2 Study of CF102 in Patients With Chronic Hepatitis C Genotype 1
NCT00790673 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Monotherapy Versus Placebo Over 14 or 17 Days in Healthy and Hepatitis C Infected Adults
NCT00439959 ·Status: TERMINATED ·Phase: PHASE1