A Phase I, Open-Label, Two-Arm Study of MP-424 in Combination With Peginterferon Alfa 2b and Ribavirin in Patients With Genotype 1b Hepatitis C
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Tanabe Pharma Corporation
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Ctrough (Minimum Observed Concentration in Plasma) of MP-424
Study Overview
Brief Summary
The purpose of this study is to assess the safety, pharmacokinetics, HCV RNA kinetics, and other viral characteristics after administration of two arms of MP-424 in combination with Peginterferon Alfa 2b (PEG-IFN-a-2b) and Ribavirin (RBV) to patients with chronic hepatitis C.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients diagnosed with genotype 1b chronic hepatitis C
Exclusion Criteria
- •Patients diagnosed with decompensated cirrhosis
- •Patients diagnosed with positive HBs antigen in the test
Arms & Interventions
Group A (MP-424 High)
Intervention: MP-424(H), PEG-IFN-a-2b, RBV (Drug)
Group B (MP-424 Low)
Intervention: MP-424 (L), PEG-IFN-a-2b, RBV (Drug)
Outcomes
Primary Outcomes
Ctrough (Minimum Observed Concentration in Plasma) of MP-424
Time Frame: Data were collected at Day1 to Day85
Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.
Cmax (Maximum Observed Concentration in Plasma) of MP-424
Time Frame: Data were collected at Day1 to Day85
Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.
Tmax (Time of Maximum Concentration in Plasma) of MP-424
Time Frame: Data were collected at Day1 to Day85
Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.
AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424
Time Frame: Data were collected at Day1 to Day85
Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.
T1/2(Time of Half-Life) of MP-424
Time Frame: Data were collected at Day1 to Day85
Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.
Secondary Outcomes
- Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels(37 weeks)