A Study to Investigate the Effect of Steady-State TMC278 on the Pharmacokinetics of a Single Dose of Digoxin

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

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-04-30

Brief Summary

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The purpose of this study is to investigate the effect of steady-state (constant concentration of medication in the blood) TMC278 on the single dose pharmacokinetics (what the body does to the medication) of digoxin.

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Detailed Description

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This is an open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), crossover (method used to switch patients from one treatment arm to another in a clinical study) study to investigate the effect of steady-state TMC278 on the single dose pharmacokinetics of digoxin. The study consists of 3 phases, including screening phase, treatment phase, and follow-up phase. After the screening phase, participants will be randomized to one of 2 treatment sequences consisting of Treatments A and B, ie, Sequence AB (11 participants), and Sequence BA (11 participants). Treatment phase includes, Treatment A: digoxin 0.5 mg (single oral dose), and Treatment B: TMC278 25 mg once daily with digoxin 0.5 mg (single oral dose). The 2 consecutive sequences will be separated by a washout period (period when receiving no treatment) of at least 14 days. Safety evaluations for adverse events, clinical laboratory tests, electrocardiograms, cardiac telemetry, vital signs, physical examination, alcohol breath test, and specific toxicities will be monitored throughout the study.The study duration for treatment phase will be at least 26 days.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment sequence AB

In Treatment A, digoxin 0.5 mg (single oral dose) will be administered on Day 1. In Treatment B, TMC278 at 25 mg, once daily will be administered for 16 days, with digoxin 0.5 mg (single oral dose) administered in the morning on Day 11.

Group Type EXPERIMENTAL

Treatment A: Digoxin

Intervention Type DRUG

Type=exact number, unit=mg, number=0.5, form=tablet, route=oral. Digoxin administered on Day 1.

Treatment B: TMC278

Intervention Type DRUG

Type=exact number, unit=mg, number=25, form=tablet, route=oral. TMC278 administered for 16 days, with digoxin administered in the morning on Day 11.

Treatment sequence BA

In Treatment B, TMC278 at 25 mg, once daily will be administered for 16 days, with digoxin 0.5 mg (single oral dose) administered in the morning on Day 11. In Treatment A, digoxin 0.5 mg (single oral dose) will be administered on Day 1.

Group Type EXPERIMENTAL

Treatment A: Digoxin

Intervention Type DRUG

Type=exact number, unit=mg, number=0.5, form=tablet, route=oral. Digoxin administered on Day 1.

Treatment B: TMC278

Intervention Type DRUG

Type=exact number, unit=mg, number=25, form=tablet, route=oral. TMC278 administered for 16 days, with digoxin administered in the morning on Day 11.

Interventions

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Treatment A: Digoxin

Type=exact number, unit=mg, number=0.5, form=tablet, route=oral. Digoxin administered on Day 1.

Intervention Type DRUG

Treatment B: TMC278

Type=exact number, unit=mg, number=25, form=tablet, route=oral. TMC278 administered for 16 days, with digoxin administered in the morning on Day 11.

Intervention Type DRUG

Other Intervention Names

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Digoxin TMC278

Eligibility Criteria

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Inclusion Criteria

* Women must be postmenopausal for at least 2 years, or be surgically sterile
* Men must agree to use a highly effective method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study medication

Exclusion Criteria

* A positive HIV-1 or HIV-2 test at screening
* Hepatitis A, B or C infection at screening
* History of clinically relevant heart rhythm disturbances
* History of idiopathic hypertrophic subaortic stenosis, atrioventricular block, ventricular tachycardia/ventricular fibrillation or family history of sudden cardiac death

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes