Status:
COMPLETED
A Study to Investigate the Effect of Steady-State TMC278 on the Pharmacokinetics of a Single Dose of Digoxin
Lead Sponsor:
Janssen R&D Ireland
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 medicat...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01519128
Start Date
January 1 2012
End Date
April 1 2012
Last Update
March 4 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Merksem, Belgium