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

Phase 1CompletedNCT01519128

Janssen R&D Ireland22 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Treatment A: DigoxinDRUG

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

Treatment B: TMC278DRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Merksem, Belgium

Outcomes

Primary Outcomes

Maximum plasma concentration (Cmax) of digoxin following single dose administration of digoxin co-administered with TMC278, compared to single dose administration of digoxin

Pharmacokinetic parameter Cmax of digoxin was measured following single dose administration of digoxin co-administered with TMC278, compared to single dose administration of digoxin.

Time frame: Up to 46 Days

Area under the plasma concentration versus time curve (AUC) of digoxin following single dose administration of digoxin co-administered with TMC278, compared to single dose administration of digoxin

Pharmacokinetic parameter AUC of digoxin was measured following single dose administration of digoxin co-administered with TMC278, compared to single dose administration of digoxin.

Time frame: Up to 46 Days

Secondary Outcomes

Number of participants with adverse events

Time frame: Up to 58 Days

Data from ClinicalTrials.gov

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