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

Phase 1

Completed

• Conditions: Chronic Hepatitis C
• Interventions: Drug: MP-424 (Telaprevir)

• Registration Number: NCT00591214
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-26
• Study First Submitted QC: 2007-12-26
• Study First Posted: 2008-01-11
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2012-09-19
• Results First Submitted QC: 2012-09-19
• Results First Posted: 2012-10-22
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-15
• Last Update Posted: 2014-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MP-424	MP-424 (Telaprevir)	-

Primary Outcome Measures

Name	Time	Method
Cmax (Maximum Observed Concentration in Plasma) of MP-424	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.
Tmax (Time of Maximum Plasma Concentration) of MP-424	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.
AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424	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.
Ctrough (Plasma Trough Concentration) of MP-424	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.
t1/2 (Half Life Period) of MP-424	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 Outcome Measures

Name	Time	Method
Change in HCV RNA Levels of MP-424	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)).

Trial Locations

Locations (1)

Toranomon Hospital; 🇯🇵 Kawasaki City, Takatsu-ku, Japan