Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Velpatasvir in Participants With Chronic HCV Infection

Gilead Sciences

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis C Virus

Treatments: Drug: Velpatasvir; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01740791

GS-US-281-0102

Details and patient eligibility

About

The primary objective of the study is to evaluate the safety, tolerability, and antiviral activity of velpatasvir (formerly GS-5816) in HCV treatment naive participants with genotypes 1-6.

Enrollment: 103 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• HCV treatment-naive adult participants (18-65 years of age) with chronic HCV infection and plasma HCV RNA ≥ 5 log10 IU/mL at screening
• Agree to use protocol defined precautions against pregnancy

Key Exclusion Criteria:

• Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, α1 antitrypsin deficiency, cholangitis)
• Evidence of cirrhosis
• Evidence of current drug abuse
• Screening laboratory results outside the protocol specified requirements

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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103 participants in 12 patient groups

Velpatasvir 5 mg (GT 1a)

Experimental group

Description:

Participants with genotype (GT) 1a HCV infection will receive velpatasvir 5 mg or placebo once daily for 3 days under fasted conditions.

Treatment:

Drug: Velpatasvir

Drug: Placebo

Velpatasvir 25 mg (GT 1a)

Experimental group

Description:

Participants with GT 1a HCV infection will receive velpatasvir 25 mg or placebo once daily for 3 days under fasted conditions.

Treatment:

Drug: Velpatasvir

Drug: Placebo

Velpatasvir 50 mg (GT 1a)

Experimental group

Description:

Participants with GT 1a HCV infection will receive velpatasvir 50 mg or placebo once daily for 3 days under fasted conditions.

Treatment:

Drug: Velpatasvir

Drug: Placebo

Velpatasvir 100 mg (GT 1a)

Experimental group

Description:

Participants with GT 1a HCV infection will receive velpatasvir 100 mg or placebo once daily for 3 days under fasted conditions.

Treatment:

Drug: Velpatasvir

Drug: Placebo

Velpatasvir 150 mg (GT 1a)

Experimental group

Description:

Participants with GT 1a HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions.

Treatment:

Drug: Velpatasvir

Drug: Placebo

Velpatasvir 150 mg (GT 1b)

Experimental group

Description:

Participants with GT 1b HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions.

Treatment:

Drug: Velpatasvir

Drug: Placebo

Velpatasvir 150 mg (GT 2)

Experimental group

Description:

Participants with GT 2 HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions.

Treatment:

Drug: Velpatasvir

Drug: Placebo

Velpatasvir 25 mg (GT 3)

Experimental group

Description:

Participants with GT 3 HCV infection will receive velpatasvir 25 mg or placebo once daily for 3 days under fasted conditions.

Treatment:

Drug: Velpatasvir

Drug: Placebo

Velpatasvir 50 mg (GT 3)

Experimental group

Description:

Participants with GT 3 HCV infection will receive velpatasvir 50 mg or placebo once daily for 3 days under fasted conditions.

Treatment:

Drug: Velpatasvir

Drug: Placebo

Velpatasvir 150 mg (GT 3)

Experimental group

Description:

Participants with GT 3 HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions.

Treatment:

Drug: Velpatasvir

Drug: Placebo

Velpatasvir 150 mg (GT 4)

Experimental group

Description:

Participants with GT 4 HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions.

Treatment:

Drug: Velpatasvir

Drug: Placebo

Velpatasvir up to 400 mg (GT 2)

Experimental group

Description:

Participants with GT 2 HCV infection will receive velpatasvir up to 400 mg or placebo once daily for 3 days under fasted conditions.

Treatment:

Drug: Velpatasvir

Drug: Placebo