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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen R&D Ireland
ClinicalTrials.gov Identifier:
NCT01519128
First received: December 27, 2011
Last updated: March 1, 2013
Last verified: March 2013

December 27, 2011
March 1, 2013
January 2012
April 2012   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
    Pharmacokinetic parameter Cmax of digoxin was measured following single dose administration of digoxin co-administered with TMC278, compared to single dose administration of digoxin.
  • 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 ] [ Designated as safety issue: No ]
    Pharmacokinetic parameter AUC of digoxin was measured following single dose administration of digoxin co-administered with TMC278, compared to single dose administration of digoxin.
  • Change in the Peak Plasma Concentration (Cmax) of digoxin following single dose administration of digoxin co-administered with TMC278, compared to single dose administration of digoxin. [ Time Frame: Measured on Day 1 (treatment A) and Day 11 (treatment B). Reference is Day 1 of treatment A. ] [ Designated as safety issue: No ]
    Change in the Peak Plasma Concentration (Cmax) of digoxin following co-administration of single dose digoxin with steady-state concentration of TMC278 as compared to Cmax of single dose digoxin alone. Cmax of digoxin is determined based on the plasma levels at Day 1 for treatment A, and at Day 11 for treatment B.
  • Change in the 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: Measured on Day 1 (treatment A) and Day 11 (treatment B). Reference is Day 1 of treatment A. ] [ Designated as safety issue: No ]
    Change in the Area under the plasma concentration versus time curve (AUC) of digoxin following co-administration of single dose digoxin with steady-state concentration of TMC278 as compared to AUC of single dose digoxin alone. AUC of digoxin is determined based on the plasma levels at Day 1 for treatment A, and at Day 11 for treatment B.
Complete list of historical versions of study NCT01519128 on ClinicalTrials.gov Archive Site
Number of participants with adverse events [ Time Frame: Up to 58 Days ] [ Designated as safety issue: No ]
Number of participants with adverse events as a measure of safety and tolerability when combining digoxin with TMC278. [ Time Frame: Up to Day 58. ] [ Designated as safety issue: No ]
to explore the short-term safety and tolerability following coadministration of TMC278 at steady-state concentration and a single dose of digoxin in healthy participants.
Not Provided
Not Provided
 
A Study to Investigate the Effect of Steady-State TMC278 on the Pharmacokinetics of a Single Dose of Digoxin
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • Drug: Treatment A: Digoxin
    Type=exact number, unit=mg, number=0.5, form=tablet, route=oral. Digoxin administered on Day 1.
    Other Name: 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 Name: TMC278
  • 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.
    Interventions:
    • Drug: Treatment A: Digoxin
    • Drug: Treatment B: 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.
    Interventions:
    • Drug: Treatment A: Digoxin
    • Drug: Treatment B: TMC278
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01519128
CR100750, TMC278IFD1001, 2011-004159-38
No
Janssen R&D Ireland
Janssen R&D Ireland
Not Provided
Study Director: Janssen R&D Ireland Clinical Trial Janssen R&D Ireland
Janssen R&D Ireland
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP