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

March 1, 2013 updated by: Janssen R&D Ireland

A Phase I, Open Label, Randomized, Crossover Trial in Healthy Subjects to Investigate the Effect of Steady-state TMC278 on the Pharmacokinetics of a Single Dose of Digoxin

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: Treatment A: Digoxin
Type=exact number, unit=mg, number=0.5, form=tablet, route=oral. Digoxin administered on Day 1.
Other Names:
  • Digoxin
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.
Other Names:
  • TMC278
EXPERIMENTAL: 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.
Drug: Treatment A: Digoxin
Type=exact number, unit=mg, number=0.5, form=tablet, route=oral. Digoxin administered on Day 1.
Other Names:
  • Digoxin
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.
Other Names:
  • TMC278

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum plasma concentration (Cmax) of digoxin following single dose administration of digoxin co-administered with TMC278, compared to single dose administration of digoxin
Time Frame: Up to 46 Days
Pharmacokinetic parameter Cmax of digoxin was measured following single dose administration of digoxin co-administered with TMC278, compared to single dose administration of digoxin.
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
Time Frame: Up to 46 Days
Pharmacokinetic parameter AUC of digoxin was measured following single dose administration of digoxin co-administered with TMC278, compared to single dose administration of digoxin.
Up to 46 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events
Time Frame: Up to 58 Days
Up to 58 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen R&D Ireland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

April 1, 2012

Study Completion (ACTUAL)

April 1, 2012

Study Registration Dates

First Submitted

December 27, 2011

First Submitted That Met QC Criteria

January 23, 2012

First Posted (ESTIMATE)

January 26, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 4, 2013

Last Update Submitted That Met QC Criteria

March 1, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR100750
  • TMC278IFD1001 (OTHER: Janssen R&D Ireland)
  • 2011-004159-38 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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