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Completed

NCT Number: NCT00591214

Safety and PK Study of MP-424 to Treat Chronic 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.

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Toranomon Hospital

Kawasaki, Takatsu-ku, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MP-424 (Telaprevir)

Drug

Three tablets of MP-424 250mg tablet at a time, every 8 hours, 12 weeks administration (dose in a day: 2250 mg)

Primary outcomes

  1. Cmax (Maximum Observed Concentration in Plasma) of MP-424

    Time frame: Date were collected at Day1 to Day85

    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.

  2. Tmax (Time of Maximum Plasma Concentration) of MP-424

    Time frame: Date were collected at Day1 to Day85

    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.

  3. AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424

    Time frame: Date were collected at Day1 to Day85

    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.

  4. Ctrough (Plasma Trough Concentration) of MP-424

    Time frame: Date were collected at Day1 to Day85

    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.

  5. t1/2 (Half Life Period) of MP-424

    Time frame: Date were collected at Day1 to Day85

    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.

Secondary outcomes

  1. Change in HCV RNA Levels of MP-424

    Time frame: Day1 (2.5, 4, 8, 16 hours), Day2, Day3, Day8, Day14, Day29, Day43, Day57 and Day86

    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)).

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Collaborators

  • Vertex Pharmaceuticals Incorporated

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 11, 2008
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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