Safety and PK Study of MP-424 to Treat Chronic Hepatitis C

A Phase I, Open-Label, Single-Dose Study of MP-424 in Patients With Genotype 1b Hepatitis C

The purpose of this study is to assess the safety, pharmacokinetics and HCV(Hepatitis C virus) RNA (Ribonucleic Acid) kinetics after administration of MP-424 to patients with chronic hepatitis C.

Study Overview

• Status: Completed
• Conditions: Chronic Hepatitis C
• Intervention / Treatment: Drug: MP-424 (Telaprevir)

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Takatsu-ku
    • Kawasaki, Takatsu-ku, Japan
      • Toranomon Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients diagnosed with genotype 1b chronic hepatitis C
• Patients naive to the concomitant medications with interferon

Exclusion Criteria:

• Patients diagnosed with decompensated cirrhosis
• Patients diagnosed with positive HBs(Hepatitis B virus surface) antigen in the test

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MP-424	Drug: MP-424 (Telaprevir); Three tablets of MP-424 250mg tablet at a time, every 8 hours, 12 weeks administration (dose in a day: 2250 mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax (Maximum Observed Concentration in Plasma) of MP-424	Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.	Date were collected at Day1 to Day85
Tmax (Time of Maximum Plasma Concentration) of MP-424	Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.	Date were collected at Day1 to Day85
AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424	Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.	Date were collected at Day1 to Day85
Ctrough (Plasma Trough Concentration) of MP-424	Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.	Date were collected at Day1 to Day85
t1/2 (Half Life Period) of MP-424	Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.	Date were collected at Day1 to Day85

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HCV RNA Levels of MP-424	Date were collected at Day -28, Day1 (0 (pre-dose), 2.5, 4, 8, 16 hours post-dose), Day2, Day3, Day8, Day14, Day29, Day43, Day57, Day86. Change Value was calculated as the each time point minus the baseline point which was averaged Day -28 and Day0-0hour(pre-dose)).	Day1 (2.5, 4, 8, 16 hours), Day2, Day3, Day8, Day14, Day29, Day43, Day57 and Day86

Collaborators and Investigators

• Sponsor: Tanabe Pharma Corporation
• Collaborators: Vertex Pharmaceuticals Incorporated
• Investigators: Principal Investigator: Fumitaka Suzuki, MD, Department of Hepatology, Toranomon Hospital

Publications and helpful links

General Publications

• Yamada I, Suzuki F, Kamiya N, Aoki K, Sakurai Y, Kano M, Matsui H, Kumada H. Safety, pharmacokinetics and resistant variants of telaprevir alone for 12 weeks in hepatitis C virus genotype 1b infection. J Viral Hepat. 2012 Feb;19(2):e112-9. doi: 10.1111/j.1365-2893.2011.01514.x. Epub 2011 Oct 7.

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: December 26, 2007
• First Submitted That Met QC Criteria: December 26, 2007
• First Posted (Estimated): January 11, 2008

Study Record Updates

• Last Update Posted (Estimated): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Chronic Hepatitis C; Protease Inhibitor
• Additional Relevant MeSH Terms: Blood-Borne Infections; Pathologic Processes; Chronic Disease; Disease Attributes; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; Flaviviridae Infections; Hepatitis, Chronic; Hepatitis; Pathological Conditions, Signs and Symptoms; Hepatitis C; Hepatitis C, Chronic; telaprevir
• Other Study ID Numbers: G060-A3