A Study to Examine the Pharmacokinetics, Safety and Tolerability of Multiple Oral Doses of TMC435 in Healthy Chinese Participants

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: TMC435 100 mg

Drug: TMC435 150 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT02071355

CR018526

TMC435HPC1001 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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