Status:
COMPLETED
TMC435350-TiDP16-C105: Phase I, 3-way Crossover, Drug-drug Interaction Between TMC435350 and Rifampin After Multiple Dosing.
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Conditions:
Hepatitis C
HCV
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the interactions seen when somebody doses with TMC435350 and Rifampin (commercial form of antibiotic).
Detailed Description
This is a Phase I, open-label, randomized, 3-way crossover trial in 18 healthy volunteers to investigate the potential drug-drug interaction between rifampin and TMC435350. TMC435350 is a protease inh...
Eligibility Criteria
Inclusion
- Volunteers must meet all of the following inclusion criteria: Non smoking for at least 3 months prior to selection, Normal weight as defined by a body mass index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 32.0 kg/m2, extremes included), Informed Consent Form (ICF) signed voluntarily before the first trial related activity, Able to comply with protocol requirements, Normal 12-lead electrocardiogram (ECG) (in triplicate) at screening including: Normal sinus rhythm (heart rate \[HR\] between 40 and 100 bpm), QTc interval = 450 ms, QRS interval \< 120 ms, PR interval = 220 ms
- Healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical history, vital signs, and the results of blood biochemistry, and hematology tests and a urinalysis carried out at screening.
Exclusion
- Past history of heart arrhythmias (extrasystole, tachycardia at rest) or having baseline prolongation of QTc interval \> 450 ms
- history of risk factors for Torsade de Pointes syndrome (hypokalemia, family history of long QT syndrome)
- Female, except if postmenopausal since more than 2 years, or posthysterectomy, or post tubal ligation (without reversal operation)
- History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in the investigator's opinion would compromise subject's safety and/or compliance with the trial procedures
- Hepatitis A, B, or C infection (confirmed by hepatitis A antibody, hepatitis B surface antigen, or hepatitis C virus antibody, respectively) or human immunodeficiency virus - type 1 (HIV-1) or HIV-2 infection at screening
- A positive urine drug test at screening
- Currently active or underlying gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, or infectious disease
- Currently significant diarrhea, gastric stasis, or constipation that in the investigator's opinion could influence drug absorption or bioavailability
- Any history of significant skin disease.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00741169
Start Date
June 1 2008
End Date
December 1 2008
Last Update
April 18 2013
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