A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of TMC647055 in Combination With Ritonavir (Part 1) and the Co-administration of TMC435, TMC647055 and Ritonavir (Part 2) in Healthy Japanese Participants

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-04-30

Brief Summary

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The purpose of the study is to investigate the safety, tolerability, and pharmacokinetics of TMC647055 in combination with ritonavir (Part 1); potential pharmacokinetic drug-drug interactions between TMC435 and the combination of TMC647055 with ritonavir; and to evaluate the short-term safety and tolerability when TMC435, TMC647055 and Ritonavir are co-administered (Part 2) in healthy Japanese participants.

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Detailed Description

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This is a single-center study which consists of 2 parts, sequentially conducted in 2 separate panels of 24 healthy adult Japanese participants each. Part 1 is a double-blinded (neither physician nor participant knows the treatment that the participant receives), placebo-controlled (placebo is compared with the study medication to test whether the study medication has a real effect in clinical study), randomized (the study medication is assigned by chance) single ascending dose (SAD) part which will consist of a screening phase, a treatment phase, and a follow-up visit. Part 1 will have 3 cohorts (Cohort A, B, and C) with 8 participants each and they will be randomly assigned to receive either a single oral dose of TMC647055 (6 participants) or placebo (2 participants) in combination with RTV. The study duration for each participant will be approximately 5 weeks from screening to follow-up visit as maximum in Part 1. Part 2 is an open-label, randomized, 3-way crossover part which will consist of a screening phase, 3 treatment phases, and a follow-up phase. Each of the 24 participants will receive Treatment A, B, and C in 6 sequences (Treatment ABC, BCA, CAB, ACB, BAC, and CBA) with a washout period of at least 7 days between consecutive treatments. Safety evaluation will include assessment of adverse events, clinical laboratory tests, vital signs, electrocardiogram, and physical examination. The study duration for each participant will be approximately 10 weeks from screening to follow-up visit as maximum.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TMC647055 150 mg or placebo + ritonavir (RTV)

Participants in Part 1 will receive a single oral dose of 150 mg of TMC647055 or placebo with 30 mg of RTV on Day 1.

Group Type EXPERIMENTAL

TMC647055

Intervention Type DRUG

TMC647055 150 mg (1 capsule), 450 mg (3 capsules), 600 mg (4 capsules) taken orally (by mouth) once daily on Day 1 in Part 1. TMC647055 450 mg (3 capsules), and 600 mg (4 capsules) taken orally once daily on Days 1 to 7 in Part 2

Placebo

Intervention Type DRUG

Placebo capsule once daily taken orally on Day 1 in Part 1

Ritonavir (RTV)

Intervention Type DRUG

RTV 30 mg (ie, 0.38 mL oral solution of RTV \[80 mg/mL strength\]) taken orally on Day 1 in Part 1 and on Days 1 to 7 in Part 2

TMC647055 450 mg or placebo + RTV

Participants in Part 1 will receive a single oral dose of 450 mg of TMC647055 or placebo with 30 mg of RTV on Day 1.

Group Type EXPERIMENTAL

TMC647055

Intervention Type DRUG

TMC647055 150 mg (1 capsule), 450 mg (3 capsules), 600 mg (4 capsules) taken orally (by mouth) once daily on Day 1 in Part 1. TMC647055 450 mg (3 capsules), and 600 mg (4 capsules) taken orally once daily on Days 1 to 7 in Part 2

Placebo

Intervention Type DRUG

Placebo capsule once daily taken orally on Day 1 in Part 1

Ritonavir (RTV)

Intervention Type DRUG

RTV 30 mg (ie, 0.38 mL oral solution of RTV \[80 mg/mL strength\]) taken orally on Day 1 in Part 1 and on Days 1 to 7 in Part 2

TMC647055 600 mg or placebo + RTV

Participants in Part 1 will receive a single oral dose of 600 mg of TMC647055 or placebo with 30 mg of RTV on Day 1.

Group Type EXPERIMENTAL

TMC647055

Intervention Type DRUG

TMC647055 150 mg (1 capsule), 450 mg (3 capsules), 600 mg (4 capsules) taken orally (by mouth) once daily on Day 1 in Part 1. TMC647055 450 mg (3 capsules), and 600 mg (4 capsules) taken orally once daily on Days 1 to 7 in Part 2

Placebo

Intervention Type DRUG

Placebo capsule once daily taken orally on Day 1 in Part 1

Ritonavir (RTV)

Intervention Type DRUG

RTV 30 mg (ie, 0.38 mL oral solution of RTV \[80 mg/mL strength\]) taken orally on Day 1 in Part 1 and on Days 1 to 7 in Part 2

Sequence 1 (Treatment A-B-C)

Participants in Part 2 will receive Treatment ABC in the following sequence - Treatment A: TMC435 150 mg once daily on Days 1 to 7; Treatment B: TMC435 75 mg once daily + TMC647055 450 mg once daily in combination with RTV 30 mg once daily on Days 1 to 7; and Treatment C: TMC435 100 mg once daily + TMC647055 600 mg once daily in combination with RTV 30 mg once daily on Days 1 to 7 with a washout period of 7 days between consecutive treatment sessions in each individual participant.

Group Type EXPERIMENTAL

TMC647055

Intervention Type DRUG

TMC647055 150 mg (1 capsule), 450 mg (3 capsules), 600 mg (4 capsules) taken orally (by mouth) once daily on Day 1 in Part 1. TMC647055 450 mg (3 capsules), and 600 mg (4 capsules) taken orally once daily on Days 1 to 7 in Part 2

TMC435

Intervention Type DRUG

TMC435 1 capsule of 75 mg, 100 mg, and 150 mg taken orally on Days 1 to 7 in Part 2

Ritonavir (RTV)

Intervention Type DRUG

RTV 30 mg (ie, 0.38 mL oral solution of RTV \[80 mg/mL strength\]) taken orally on Day 1 in Part 1 and on Days 1 to 7 in Part 2

Sequence 2 (Treatment B-C-A)

Participants in Part 2 will receive Treatment BCA in the following sequence - Treatment B: TMC435 75 mg once daily + TMC647055 450 mg once daily in combination with RTV 30 mg once daily on Days 1 to 7; Treatment C: TMC435 100 mg once daily + TMC647055 600 mg once daily in combination with RTV 30 mg once daily on Days 1 to 7; and Treatment A: TMC435 150 mg once daily on Days 1 to 7 with a washout period of 7 days between consecutive treatment sessions in each individual participant.

Group Type EXPERIMENTAL

TMC647055

Intervention Type DRUG

TMC647055 150 mg (1 capsule), 450 mg (3 capsules), 600 mg (4 capsules) taken orally (by mouth) once daily on Day 1 in Part 1. TMC647055 450 mg (3 capsules), and 600 mg (4 capsules) taken orally once daily on Days 1 to 7 in Part 2

TMC435

Intervention Type DRUG

TMC435 1 capsule of 75 mg, 100 mg, and 150 mg taken orally on Days 1 to 7 in Part 2

Ritonavir (RTV)

Intervention Type DRUG

RTV 30 mg (ie, 0.38 mL oral solution of RTV \[80 mg/mL strength\]) taken orally on Day 1 in Part 1 and on Days 1 to 7 in Part 2

Sequence 3 (Treatment C-A-B)

Participants in Part 2 will receive Treatment CAB in the following sequence - Treatment C: TMC435 100 mg once daily + TMC647055 600 mg once daily in combination with RTV 30 mg once daily on Days 1 to 7; Treatment A: TMC435 150 mg once daily on Days 1 to 7; and Treatment B: TMC435 75 mg once daily + TMC647055 450 mg once daily in combination with RTV 30 mg once daily on Days 1 to 7 with a washout period of 7 days between consecutive treatment sessions in each individual participant.

Group Type EXPERIMENTAL

TMC647055

Intervention Type DRUG

TMC647055 150 mg (1 capsule), 450 mg (3 capsules), 600 mg (4 capsules) taken orally (by mouth) once daily on Day 1 in Part 1. TMC647055 450 mg (3 capsules), and 600 mg (4 capsules) taken orally once daily on Days 1 to 7 in Part 2

TMC435

Intervention Type DRUG

TMC435 1 capsule of 75 mg, 100 mg, and 150 mg taken orally on Days 1 to 7 in Part 2

Ritonavir (RTV)

Intervention Type DRUG

RTV 30 mg (ie, 0.38 mL oral solution of RTV \[80 mg/mL strength\]) taken orally on Day 1 in Part 1 and on Days 1 to 7 in Part 2

Sequence 4 (Treatment A-C-B)

Participants in Part 2 will receive Treatment ACB in the following sequence - Treatment A: TMC435 150 mg once daily on Days 1 to 7; Treatment C: TMC435 100 mg once daily + TMC647055 600 mg once daily in combination with RTV 30 mg once daily on Days 1 to 7; and Treatment B: TMC435 75 mg once daily + TMC647055 450 mg once daily in combination with RTV 30 mg once daily on Days 1 to 7 with a washout period of 7 days between consecutive treatment sessions in each individual participant.

Group Type EXPERIMENTAL

TMC647055

Intervention Type DRUG

TMC647055 150 mg (1 capsule), 450 mg (3 capsules), 600 mg (4 capsules) taken orally (by mouth) once daily on Day 1 in Part 1. TMC647055 450 mg (3 capsules), and 600 mg (4 capsules) taken orally once daily on Days 1 to 7 in Part 2

TMC435

Intervention Type DRUG

TMC435 1 capsule of 75 mg, 100 mg, and 150 mg taken orally on Days 1 to 7 in Part 2

Ritonavir (RTV)

Intervention Type DRUG

RTV 30 mg (ie, 0.38 mL oral solution of RTV \[80 mg/mL strength\]) taken orally on Day 1 in Part 1 and on Days 1 to 7 in Part 2

Sequence 5 (Treatment B-A-C)

Participants in Part 2 will receive Treatment BAC in the following sequence - Treatment B: TMC435 75 mg once daily + TMC647055 450 mg once daily in combination with RTV 30 mg once daily on Days 1 to 7; Treatment A: TMC435 150 mg once daily on Days 1 to 7; and Treatment C: TMC435 100 mg once daily + TMC647055 600 mg once daily in combination with RTV 30 mg once daily on Days 1 to 7 with a washout period of 7 days between consecutive treatment sessions in each individual participant.

Group Type EXPERIMENTAL

TMC647055

Intervention Type DRUG

TMC647055 150 mg (1 capsule), 450 mg (3 capsules), 600 mg (4 capsules) taken orally (by mouth) once daily on Day 1 in Part 1. TMC647055 450 mg (3 capsules), and 600 mg (4 capsules) taken orally once daily on Days 1 to 7 in Part 2

TMC435

Intervention Type DRUG

TMC435 1 capsule of 75 mg, 100 mg, and 150 mg taken orally on Days 1 to 7 in Part 2

Ritonavir (RTV)

Intervention Type DRUG

RTV 30 mg (ie, 0.38 mL oral solution of RTV \[80 mg/mL strength\]) taken orally on Day 1 in Part 1 and on Days 1 to 7 in Part 2

Sequence 6 (Treatment C-B-A)

Participants in Part 2 will receive Treatment CBA in the following sequence - Treatment C: TMC435 100 mg once daily + TMC647055 600 mg once daily in combination with RTV 30 mg once daily on Days 1 to 7; Treatment B: TMC435 75 mg once daily + TMC647055 450 mg once daily in combination with RTV 30 mg once daily on Days 1 to 7; and Treatment A: TMC435 150 mg once daily on Days 1 to 7 with a washout period of 7 days between consecutive treatment sessions in each individual participant.

Group Type EXPERIMENTAL

TMC647055

Intervention Type DRUG

TMC647055 150 mg (1 capsule), 450 mg (3 capsules), 600 mg (4 capsules) taken orally (by mouth) once daily on Day 1 in Part 1. TMC647055 450 mg (3 capsules), and 600 mg (4 capsules) taken orally once daily on Days 1 to 7 in Part 2

TMC435

Intervention Type DRUG

TMC435 1 capsule of 75 mg, 100 mg, and 150 mg taken orally on Days 1 to 7 in Part 2

Ritonavir (RTV)

Intervention Type DRUG

RTV 30 mg (ie, 0.38 mL oral solution of RTV \[80 mg/mL strength\]) taken orally on Day 1 in Part 1 and on Days 1 to 7 in Part 2

Interventions

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TMC647055

TMC647055 150 mg (1 capsule), 450 mg (3 capsules), 600 mg (4 capsules) taken orally (by mouth) once daily on Day 1 in Part 1. TMC647055 450 mg (3 capsules), and 600 mg (4 capsules) taken orally once daily on Days 1 to 7 in Part 2

Intervention Type DRUG

TMC435

TMC435 1 capsule of 75 mg, 100 mg, and 150 mg taken orally on Days 1 to 7 in Part 2

Intervention Type DRUG

Placebo

Placebo capsule once daily taken orally on Day 1 in Part 1

Intervention Type DRUG

Ritonavir (RTV)

RTV 30 mg (ie, 0.38 mL oral solution of RTV \[80 mg/mL strength\]) taken orally on Day 1 in Part 1 and on Days 1 to 7 in Part 2

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Man or woman of Japanese descent who has resided outside Japan for no more than 5 years and whose parents and grandparents are Japanese as determined by participant's verbal report
* Must have signed an informed consent form
* Women must be of non-child-bearing potential (postmenopausal for at least 2 years, surgically sterile, or otherwise incapable of becoming pregnant)
* Women, except for postmenopausal women, should have a negative serum b-human chorionic gonadotropin pregnancy test at screening
* Men heterosexually active with a woman of childbearing potential must agree to use two effective methods of birth control, and all men must also not donate sperm during the study and for 3 months after receiving the last dose of study medication
* Must have a body mass index between 16.0 and 30.0 kg/m2, inclusive, and body weight not less than 45 kg at screening

Exclusion Criteria

* History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use within the past 1 year which in the Investigator's opinion would compromise participant's safety and/or compliance with the study procedures
* Participant's with Hepatitis A, B, or C infection, or human immunodeficiency virus type 1 or 2 (HIV-1 or HIV-2) infection at study screening
* Female participants who are breastfeeding at screening
* History of liver or renal impairment, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances
* History of clinically relevant skin disease or history of allergy to any medication

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes