A Phase 1 interventional study of Treatment A: Digoxin and Treatment B: TMC278 in Healthy, sponsored by Janssen R&D Ireland. Completed at 1 site in Belgium. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-03-04.
Sponsored by Janssen R&D Ireland (part of Johnson & Johnson) · Phase 1, Interventional, and Treatment
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.
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This study's enrollment of 22 is below the median of 104 across 1,590 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Janssen R&D Ireland is the lead sponsor of 32 studies on the registry; none are open to participants now.
First submitted after Janssen R&D Ireland became part of Johnson & Johnson.
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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 · Drug: Treatment B: TMC278
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 · Drug: Treatment B: TMC278
Type=exact number, unit=mg, number=0.5, form=tablet, route=oral. Digoxin administered on Day 1.
Also known as: Digoxin
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.
Also known as: TMC278
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
Number of participants with adverse events
Time frame: Up to 58 Days
This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Digoxin · Rilpivirine
Acquired Immunodeficiency Syndrome →