Status:
COMPLETED
A Study of Drug-drug Interaction Between Ritonavir and TMC435350 in Healthy Volunteers
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the drug-drug interaction between steady-state concentrations of CYP3A4 or ritonavir and TMC435350 after its first and the last dose of the multiple dosing reg...
Detailed Description
This trial is a Phase I, open label trial (meaning that both the research physician and study participants will know which medication is being administered during the trial) in 12 healthy volunteers (...
Eligibility Criteria
Inclusion
- non-smoking for at least 3 months prior to selection
- normal weight as defined by a Quetelet Index (Body Mass Index: weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included
- Informed Consent Form signed voluntarily, prior to the first trial related activity
- normal 12-lead electrocardiogram (ECG) at screening
- healthy on the basis of a medical evaluation and results fo the laboratory tests at screening.
Exclusion
- past history of heart arrhythmias,
- female, except if postmenopausal for more than two years, or post-hysterectomy or post-tubal ligation (without reversal operation)
- history or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use
- hepatitis A, B and C infections or human immunodeficiency virus type 1 (HIV-1) or HIV-2 infections at study screening
- donation of blood or plasma in the 60 days preceding the first intake of trial medication
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01891851
Start Date
October 1 2007
End Date
January 1 2008
Last Update
October 14 2013
Active Locations (1)
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1
Aalst, Belgium