NCT01519128

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2011

Completed
5 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 26, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

March 4, 2013

Status Verified

March 1, 2013

Enrollment Period

3 months

First QC Date

December 27, 2011

Last Update Submit

March 1, 2013

Conditions

Healthy

Keywords

HealthyTMC278TMC278IFD1001Human immunodeficiency virus - type 1PharmacokineticsDigoxin

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Up to 46 Days

Secondary Outcomes (1)

  • Number of participants with adverse events

    Up to 58 Days

Study Arms (2)

Treatment sequence AB

EXPERIMENTAL

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: DigoxinDrug: Treatment B: TMC278

Treatment sequence BA

EXPERIMENTAL

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: DigoxinDrug: Treatment B: TMC278

Interventions

Treatment A: DigoxinDRUG

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

Also known as: Digoxin
Treatment sequence ABTreatment sequence BA
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.

Also known as: TMC278
Treatment sequence ABTreatment sequence BA

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Merksem, Belgium

Location

Related Links

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

DigoxinRilpivirine

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Digitalis GlycosidesCardenolidesCardiac GlycosidesCardanolidesSteroidsFused-Ring CompoundsPolycyclic CompoundsGlycosidesCarbohydratesNitrilesOrganic ChemicalsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Janssen R&D Ireland Clinical Trial

    Janssen R&D Ireland

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2011

First Posted

January 26, 2012

Study Start

January 1, 2012

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

March 4, 2013

Record last verified: 2013-03

Locations

BE(1)