Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Voxilaprevir in Adults With Chronic Hepatitis C Virus Infection
NCT ID: NCT02185794
Last Updated: 2020-09-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
101 participants
INTERVENTIONAL
2014-06-13
2015-09-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo (GT 1a, Cohort 1)
Participants with genotype (GT) 1a HCV infection will receive placebo once daily for 3 days under fasted conditions.
Placebo to match voxilaprevir
Placebo to match voxilaprevir tablets administered orally once daily
Voxilaprevir 50 mg (GT 1a, Cohort 1)
Participants with GT 1a HCV infection will receive voxilaprevir 50 mg once daily for 3 days under fasted conditions.
Voxilaprevir
Voxilaprevir tablets administered orally once daily
Voxilaprevir 100 mg (GT 1a, Cohort 1)
Participants with GT 1a HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.
Voxilaprevir
Voxilaprevir tablets administered orally once daily
Voxilaprevir 300 mg (GT 1a, Cohort 1)
Participants with GT 1a HCV infection will receive voxilaprevir 300 mg once daily for 3 days under fasted conditions.
Voxilaprevir
Voxilaprevir tablets administered orally once daily
Placebo (GT 3, Cohort 2)
Participants with GT 3 HCV infection will receive placebo once daily for 3 days under fasted conditions.
Placebo to match voxilaprevir
Placebo to match voxilaprevir tablets administered orally once daily
Voxilaprevir 50 mg (GT 3, Cohort 2)
Participants with GT 3 HCV infection will receive voxilaprevir 50 mg once daily for 3 days under fasted conditions.
Voxilaprevir
Voxilaprevir tablets administered orally once daily
Voxilaprevir 100 mg (GT 3, Cohort 2)
Participants with GT 3 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.
Voxilaprevir
Voxilaprevir tablets administered orally once daily
Voxilaprevir 300 mg (GT 3, Cohort 2)
Participants with GT 3 HCV infection will receive voxilaprevir 300 mg once daily for 3 days under fasted conditions.
Voxilaprevir
Voxilaprevir tablets administered orally once daily
Placebo (GT 2, Cohort 3)
Participants with GT 2 HCV infection will receive placebo once daily for 3 days under fasted conditions.
Placebo to match voxilaprevir
Placebo to match voxilaprevir tablets administered orally once daily
Voxilaprevir 100 mg (GT 2, Cohort 3)
Participants with GT 2 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.
Voxilaprevir
Voxilaprevir tablets administered orally once daily
Voxilaprevir 100 mg (GT 4, Cohort 4)
Participants with GT 4 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.
Voxilaprevir
Voxilaprevir tablets administered orally once daily
Voxilaprevir 100 mg (GT 1b, Cohort 5)
Participants with GT 1b HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.
Voxilaprevir
Voxilaprevir tablets administered orally once daily
Voxilaprevir 100 mg Fed (GT 3a, Cohort 6)
Participants with GT 3a HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fed conditions.
Voxilaprevir
Voxilaprevir tablets administered orally once daily
Voxilaprevir 600 mg (Cohorts 7-9)
Participants with genotypes 1a, 1b, 2, 3, or 4 HCV infection will receive voxilaprevir up to 600 mg under fasted or fed conditions for 3 days.
Voxilaprevir
Voxilaprevir tablets administered orally once daily
Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 1, Cohort 10)
Participants with any GT HCV infection received voxilaprevir 100 mg on Day 1 after moderate fat meal and voxilaprevir 100 mg plus sofosbuvir (SOF)/velpatasvir (VEL) (400/100 mg) fixed-dose combination (FDC)on Days 2 and 3 after either a light or moderate-fat meal.
Voxilaprevir
Voxilaprevir tablets administered orally once daily
SOF/VEL
400 mg/100 mg FDC tablet administered orally once daily
Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 2, Cohort 10)
Participants with any GT HCV infection received voxilaprevir 100 mg on Day 1 and voxilaprevir 100 mg plus SOF/VEL (400/100 mg) FDC on Days 2 and 3 after moderate fat meal.
Voxilaprevir
Voxilaprevir tablets administered orally once daily
SOF/VEL
400 mg/100 mg FDC tablet administered orally once daily
Interventions
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Voxilaprevir
Voxilaprevir tablets administered orally once daily
Placebo to match voxilaprevir
Placebo to match voxilaprevir tablets administered orally once daily
SOF/VEL
400 mg/100 mg FDC tablet administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* For Cohorts 1-9, HCV RNA ≥ 100,000 IU/mL at screening (no HCV RNA restriction for Cohort 10)
* Screening laboratory values within defined thresholds
* Use of two effective contraception methods if female of childbearing potential or sexually active male
Exclusion Criteria
* Presence of cirrhosis
* Prior exposure to approved or experimental HCV Protease Inhibitors
* Co-infection with HIV or hepatitis B virus (HBV)
* Current or prior history of clinical hepatic decompensation
* Chronic use of systemic immunosuppressive agents
* History of clinically significant illness or any other medical disorder that may interfere with participant's treatment, assessment or compliance with the protocol
18 Years
65 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Costa Mesa, California, United States
DeLand, Florida, United States
Orlando, Florida, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Berlin, New Jersey, United States
Marlton, New Jersey, United States
Philadelphia, Pennsylvania, United States
Knoxville, Tennessee, United States
San Antonio, Texas, United States
San Juan, , Puerto Rico
Countries
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References
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Rodriguez-Torres M, Glass S, Hill J, Freilich B, Hassman D, Di Bisceglie A, Taylor J, Kirby B, Yang J, An D, Stamm L, Brainard D, Kim S, Krefetz D, Smith W, Marbury T, Lawitz E. The Pangenotypic NS3/4A Protease Inhibitor GS-9857 Demonstrates Potent Antiviral Activity in Patients Infected With HCV Genotype 1, 2, 3, or 4 in a 3-Day Monotherapy Study [Poster P0901]. Presented at the European Association for the Study of the Liver (EASL) 50th International Liver Congress 2015, April 22-26, 2015, Vienna, Austria.
Lawitz E, Yang JC, Stamm LM, Taylor JG, Cheng G, Brainard DM, Miller MD, Mo H, Dvory-Sobol H. Characterization of HCV resistance from a 3-day monotherapy study of voxilaprevir, a novel pangenotypic NS3/4A protease inhibitor. Antivir Ther. 2018;23(4):325-334. doi: 10.3851/IMP3202.
Other Identifiers
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GS-US-338-1121
Identifier Type: -
Identifier Source: org_study_id
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