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

Tanabe Pharma Corporation

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis C

Treatments: Drug: MP-424 (Telaprevir)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00591214

G060-A3

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

MP-424

Experimental group

Treatment:

Drug: MP-424 (Telaprevir)