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

This study has been completed.
Sponsor:
Collaborator:
Vertex Pharmaceuticals Incorporated
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00591214
First received: December 26, 2007
Last updated: November 21, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C
Drug: MP-424 (Telaprevir)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Phase I, Open-Label, Single-Dose Study of MP-424 in Patients With Genotype 1b Hepatitis C

Resource links provided by NLM:


Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Cmax (Maximum Observed Concentration in Plasma) of MP-424 [ Time Frame: Date were collected at Day1 to Day85 ] [ Designated as safety issue: No ]
    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.

  • Tmax (Time of Maximum Plasma Concentration) of MP-424 [ Time Frame: Date were collected at Day1 to Day85 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Ctrough (Plasma Trough Concentration) of MP-424 [ Time Frame: Date were collected at Day1 to Day85 ] [ Designated as safety issue: No ]
    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.

  • t1/2 (Half Life Period) of MP-424 [ Time Frame: Date were collected at Day1 to Day85 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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)).



Enrollment: 10
Study Start Date: December 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00591214

Locations
Japan
Toranomon Hospital
Kawasaki City, Takatsu-ku, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Vertex Pharmaceuticals Incorporated
Investigators
Principal Investigator: Fumitaka Suzuki, MD Department of Hepatology, Toranomon Hospital
  More Information

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00591214     History of Changes
Other Study ID Numbers: G060-A3
Study First Received: December 26, 2007
Results First Received: September 19, 2012
Last Updated: November 21, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Chronic Hepatitis C
Protease Inhibitor

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 15, 2014