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

NCT ID: NCT02071355

Last Updated: 2014-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-06-30

Brief Summary

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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

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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.

Conditions

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Healthy

Keywords

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Healthy Chinese participants TMC435 Multiple oral doses Pharmacokinetics Safety Tolerability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

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

Group Type EXPERIMENTAL

TMC435 100 mg

Intervention Type DRUG

Participants will receive TMC435 100 mg capsule once daily from Day 1 to Day 7 after food.

Group 2

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

Group Type EXPERIMENTAL

TMC435 150 mg

Intervention Type DRUG

Participants will receive TMC435 150 mg capsule once daily from Day 1 to Day 7 after food.

Interventions

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TMC435 100 mg

Participants will receive TMC435 100 mg capsule once daily from Day 1 to Day 7 after food.

Intervention Type DRUG

TMC435 150 mg

Participants will receive TMC435 150 mg capsule once daily from Day 1 to Day 7 after food.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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Beijing, , China

Site Status

Countries

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China

Other Identifiers

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TMC435HPC1001

Identifier Type: OTHER

Identifier Source: secondary_id

CR018526

Identifier Type: -

Identifier Source: org_study_id