Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02185794 | Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Voxilaprevir in Adults With Chronic Hepatitis C Virus Infection | PHASE1 | COMPLETED | 101 | — | — | Jun 13, 2014 | Sep 28, 2015 | Sep 17, 2020 | 11 | United States, Puerto Rico |
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The severity of laboratory abnormalities was assessed as Grade 0, 1 (mild), 2 (moderate), 3 (severe), or 4 (potentially life threatening) using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. The most severe graded abnormality from all tests was counted for each participant.
The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6). Data are summarized by treatment/cohort and placebo.
| Arm | Type | Description |
|---|---|---|
| Placebo (GT 1a, Cohort 1) | PLACEBO_COMPARATOR | Participants with genotype (GT) 1a HCV infection will receive placebo once daily for 3 days under fasted conditions. |
| Voxilaprevir 50 mg (GT 1a, Cohort 1) | EXPERIMENTAL | Participants with GT 1a HCV infection will receive voxilaprevir 50 mg once daily for 3 days under fasted conditions. |
| Voxilaprevir 100 mg (GT 1a, Cohort 1) | EXPERIMENTAL | Participants with GT 1a HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions. |
| Voxilaprevir 300 mg (GT 1a, Cohort 1) | EXPERIMENTAL | Participants with GT 1a HCV infection will receive voxilaprevir 300 mg once daily for 3 days under fasted conditions. |
| Placebo (GT 3, Cohort 2) | PLACEBO_COMPARATOR | Participants with GT 3 HCV infection will receive placebo once daily for 3 days under fasted conditions. |
| Voxilaprevir 50 mg (GT 3, Cohort 2) | EXPERIMENTAL | Participants with GT 3 HCV infection will receive voxilaprevir 50 mg once daily for 3 days under fasted conditions. |
| Voxilaprevir 100 mg (GT 3, Cohort 2) | EXPERIMENTAL | Participants with GT 3 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions. |
| Voxilaprevir 300 mg (GT 3, Cohort 2) | EXPERIMENTAL | Participants with GT 3 HCV infection will receive voxilaprevir 300 mg once daily for 3 days under fasted conditions. |
| Placebo (GT 2, Cohort 3) | PLACEBO_COMPARATOR | Participants with GT 2 HCV infection will receive placebo once daily for 3 days under fasted conditions. |
| Voxilaprevir 100 mg (GT 2, Cohort 3) | EXPERIMENTAL | Participants with GT 2 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions. |
| Voxilaprevir 100 mg (GT 4, Cohort 4) | EXPERIMENTAL | Participants with GT 4 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions. |
| Voxilaprevir 100 mg (GT 1b, Cohort 5) | EXPERIMENTAL | Participants with GT 1b HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions. |
| Voxilaprevir 100 mg Fed (GT 3a, Cohort 6) | EXPERIMENTAL | Participants with GT 3a HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fed conditions. |
| Voxilaprevir 600 mg (Cohorts 7-9) | EXPERIMENTAL | 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 100 mg + SOF/VEL 400/100 mg (Group 1, Cohort 10) | EXPERIMENTAL | 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 100 mg + SOF/VEL 400/100 mg (Group 2, Cohort 10) | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| Voxilaprevir | DRUG | Voxilaprevir tablets administered orally once daily |
| Placebo to match voxilaprevir | DRUG | Placebo to match voxilaprevir tablets administered orally once daily |
| SOF/VEL | DRUG | 400 mg/100 mg FDC tablet administered orally once daily |
Key Inclusion Criteria: * Chronic genotype 1-4 HCV infection * 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 sex...