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

Study Overview
=================
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.

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

Conditions
-----------------
Chronic Hepatitis C

Intervention / Treatment
-----------------
* Drug: MP-424 (Telaprevir)


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Hepatitis C, Protease Inhibitor