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NCT Number: NCT01224197

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

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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shatin, Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TMC435

Drug

100 or 200 mg capsule, one single dose

Primary outcomes

  1. 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

  2. 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

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Tibotec Pharmaceuticals, Ireland

Industry

Registry information

Official study title

Phase I, Open Label, Randomized Study to Examine the Pharmacokinetics, Safety and Tolerability of Different Oral Doses of TMC435 After Single and Repeated Dosing in Healthy Chinese Subjects

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 19, 2010
Registry last updated
May 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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