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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:
NCT01224197
First received: October 18, 2010
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Hepatitis C
Drug: TMC435
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Tibotec Pharmaceuticals, Ireland:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: October 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 001
TMC435 100 or 200 mg capsule one single dose
Drug: TMC435
100 or 200 mg capsule, one single dose
Experimental: 002
TMC435 100 or 200 mg capsule once daily for 5 days
Drug: TMC435
100 or 200 mg capsule, once daily for 5 days

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01224197

Locations
Hong Kong
Sha Tin, Hong Kong
Sponsors and Collaborators
Tibotec Pharmaceuticals, Ireland
Investigators
Study Director: Tibotec Pharmaceuticals Clinical Trial Tibotec Pharmaceutical Limited
  More Information

No publications provided

Responsible Party: Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier: NCT01224197     History of Changes
Other Study ID Numbers: CR017482
Study First Received: October 18, 2010
Last Updated: May 7, 2014
Health Authority: Ireland: Irish Agriculture and Food Development Authority

Keywords provided by Tibotec Pharmaceuticals, Ireland:
TMC435HPC1004
TMC435
HCV
Hepatitis C
Healthy Chinese volunteer

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Simeprevir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014