Clinical trial NCT01193478: A Multiple Ascending Dose Study of GS 5885 in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Escalating, Multiple, Oral Doses of GS 5885 in Treatment Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HCV Infection
Keywords: Hepatitis C
HCV RNA
multiple ascending dose
NS5A
GS-5885
chronic genotype 1 HCV infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2010-09-02
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and activity of escalating, multiple, oral doses of GS-5885 in subjects with chronic genotype 1 Hepatitis C Virus (HCV) infection. Each participant in the study will be sequestered in the clinic for the initial 5 days of the study.


Eligibility criteria: Inclusion Criteria:

* Chronically infected with HCV genotype 1
* HCV treatment-naïve
* Not co-infected with HIV or HBV
* HCV RNA viral load of at least 100,000 IU/mL
* BMI 19 to 35 kg/m2
* Subject agrees to use highly effective contraception methods if female of childbearing potential or sexually active male.

Exclusion Criteria:

* History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
* Decompensated liver disease or cirrhosis or evidence of hepatocellular carcinoma
* Serological evidence of co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype
* Subjects with known, current use of amphetamines and/or cocaine; subjects taking methadone or buprenorphine (opioid replacement therapy) or ongoing alcohol abuse

Primary outcomes:
measure: Number of subjects reporting an adverse event or experiencing a laboratory abnormality
timeFrame: Safety and tolerability assessments will be performed up to Study Day 14 following administration of multiple doses of GS-5885 or placebo for 3 days
measure: Antiviral activity measures: measured by change in plasma HCV RNA levels form baseline
timeFrame: Assessed up to Study Day 14 following administration of multiple doses of GS-5885 or placebo for 3 days
Secondary outcomes:
measure: Measure of GS-5885 plasma concentration over time
timeFrame: Assessed up to Study Day 14 following administration of multiple doses of GS-5885 or placebo for 3 days
measure: Emergence of viral resistance
timeFrame: Up to 48 weeks following Study Day 14
Other outcomes:
Locations:
city: Anaheim
country: United States
state: California
city: Cypress
country: United States
state: California
city: National City
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Deland
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: St. Louis
country: United States
state: Missouri
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Tacoma
country: United States
state: Washington
Study officials:
affiliation: Gilead Sciences
name: Diana Brainard, MD
role: STUDY_DIRECTOR
References:
citation: Wong KA, Worth A, Martin R, Svarovskaia E, Brainard DM, Lawitz E, Miller MD, Mo H. Characterization of Hepatitis C virus resistance from a multiple-dose clinical trial of the novel NS5A inhibitor GS-5885. Antimicrob Agents Chemother. 2013 Dec;57(12):6333-40. doi: 10.1128/AAC.02193-12. Epub 2013 Jul 22.