Phase I, Open Label Study to Examine the Pharmacokinetics, Safety and Tolerability of TMC435 Following Multiple Oral Doses of 100 and 150 mg q.d. in Healthy Chinese Subjects

Janssen Research & Development, LLC0 sites32 target enrollmentApril 2014

ConditionsHealthy

InterventionsTMC435 100 mg TMC435 150 mg

DrugsTMC435 100 mg TMC435 150 mg

Overview

Phase: Phase 1
Intervention: TMC435 100 mg
Conditions: Healthy
Sponsor: Janssen Research & Development, LLC
Enrollment: 32
Primary Endpoint: Minimum plasma concentration of TMC435
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the pharmacokinetics (what the body does to a medication) of TMC435 after multiple oral doses of 100 and 150 mg TMC435 once daily for 7 days in healthy Chinese participants.

Detailed Description

This is an open-label (both \[participants and investigator\] know what treatment participants will receive) and randomized (study medication is assigned by chance) study. The study consists of 3 phases: a screening phase (within 21 days prior to administration of study medication), a treatment phase (from day -1 \[1 days before the administration of study medication\] to Day 10 including pharmacokinetics sample collection), and follow-up phase (up to 16 days after the last dose of study medication or after dropout \[other than withdrawal of consent\]). Approximately 32 healthy participants will be equally divided into 2 groups (Group 1 and Group 2) to receive TMC435 for 7 days. Safety will be evaluated by the assessment of adverse events, clinical laboratory tests, vital signs, and physical examination which will be monitored at various timepoints throughout the study. The total duration of study participation for each participant will be approximately 47 days.

Registry

clinicaltrials.gov

Start Date

April 2014

End Date

June 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Janssen Research & Development, LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy Chinese participants on the basis of physical examination, medical history, vital signs, 12-lead electrocardiogram, and clinical laboratory tests performed at screening
•Must be non-smoking for at least 3 months prior to screening as confirmed by a urine cotinine test
•A Body Mass Index (BMI) of 18.0 to 30.0 kg/square meter, extremes included (BMI is calculated as BMI = body weight in kg divided by the square of height in meters)
•Participants must agree to use one of the contraception methods defined in the protocol

Exclusion Criteria

•Positive human immunodeficiency virus - type 1 and 2; syphilis; hepatitis A, B or C infection at screening
•History or presence of liver or renal clearance insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances
•History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic medicines use
•Any history of significant skin disease such as but not limited to, rash or eruptions, allergies, dermatitis, eczema (inflammation of the skin), psoriasis (an inflammatory skin disease), or urticarial (a raised and itchy rash that appears on the skin)
•Female participants who are breastfeeding at screening

Arms & Interventions

Group 1

Participants will receive 100 mg TMC435 once daily for 7 days.

Intervention: TMC435 100 mg

Group 2

Participants will receive 150 mg TMC435 once daily for 7 days.

Intervention: TMC435 150 mg