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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Treatment B: TMC278; Drug: Treatment A: Digoxin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01519128

2011-004159-38 (EudraCT Number)

CR100750

TMC278IFD1001 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Treatment sequence AB

Experimental group

Description:

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.

Treatment:

Drug: Treatment A: Digoxin

Drug: Treatment B: TMC278

Treatment sequence BA

Experimental group

Description:

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.

Treatment:

Drug: Treatment A: Digoxin

Drug: Treatment B: TMC278