TMC435 HPC1004 - Phase I Study Investigating the Pharmacokinetics of TMC435 in Healthy Chinese Volunteers

Tibotec Pharmaceuticals, Ireland32 enrolled

Overview

The purpose of this study is to assess the pharmacokinetics, safety and tolerability of single and multiple oral doses of TMC435 in Chinese healthy volunteers. Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body.

TMC435 is being investigated for the treatment of chronic hepatitic C infection. The results of this study will provide dosing recommendations for the administration of TMC435 in Chinese HCV-infected patients. This is a Phase I, open label (both participant and investigator know the name of the medication given at certain moment), randomized (study medication is assigned by chance) study to investigate the pharmacokinetics, safety and tolerability of TMC435 after single and repeated intakes. Each participant will receive 2 treatments. First, participants will receive TMC435 as a single dose of 100 or 200 mg. Thereafter, in the multiple dose part, 100 or 200 mg TMC435 will be administered during 5 consecutuve days every morning. Both treatments will be administered with food. There will be a washout period of at least 72 hours between the 2 treatments. The main focus of the trial is the pharmacokinetic characteristics (level-profile of TMC435 over time in the blood stream). This evaluation requires multiple blood samples from Day 1 till Day 3 in the first session and from Day 1 till Day 11 in the second session. Safety assessments (blood and urine tests, blood pressure, pulse, electrocardiogram, and physical examination) will follow a different schedule and will be performed during each treatment period, up to 4 weeks after the last. Each volunteer participate in 2 treatments, i.e., single dose period and multiple dose period. In the single dose part, planned doses will be 100 or 200 mg TMC435. In the multiple dose part, TMC435 will be administered during 5 consecutive days every morning.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis C

Interventions

TMC435DRUG

100 or 200 mg capsule, one single dose

TMC435DRUG

100 or 200 mg capsule, once daily for 5 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy based on a medical evaluation including medical history, physical examination, blood tests and electrocardiogram. Body Mass Index of 18.0 to 30.0 kg/m² and non-smoker or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months. Exclusion Criteria: * Infection with Hepatitis A, B or C virus * infection with the Human Immunodeficiency Virus (HIV) * Women who are pregnant or breastfeeding * History of, or any current medical condition which could impact the safety of the participant in the study.

Locations (1)

Unnamed facility

Shatin, Hong Kong

Outcomes

Primary Outcomes

plasma concentration of TMC435 after a single oral dose of 100 and 200 mg TMC435 in healthy Chinese volunteers in fed conditions

Time frame: measured on Day 1, 2, 3

plasma concentration of TMC435 after a multiple oral dose of 100 and 200 mg TMC435 in healthy Chinese volunteers in fed conditions

Time frame: measured on Day 4 until 11

Secondary Outcomes

Safety and tolerability of TMC435 after single oral dose of 100 and 200 mg in healthy Chinese volunteers

Time frame: Day 1 until Day 3

Safety and tolerability of TMC435 after multiple oral dose of 100 and 200 mg q.d. for 5 days in healthy Chinese volunteers

Time frame: Day 4 until Day 11 and 12 to 15 days and 38 to 43 days after last intake as safety follow up

Data from ClinicalTrials.gov

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