Status:
COMPLETED
Effects of Tipranavir (With Ritonavir) Capsule and Liquid Formulation on Cytochrome P450 and P-glycoprotein Activity in Healthy Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
Primary: To quantify the influence of single-dose and steady-state tipranavir/ritonavir 500/200 mg on intestinal and hepatic cytochrome P450 (CYP) and P-glycoprotein (P-gp) biomarkers, as a means of p...
Eligibility Criteria
Inclusion
- Signed informed consent
- Healthy subjects aged between 18 years and 45 years inclusive
- Weighing at least 50 kg
- Volunteers must be hospitalized on Days 1-4, 7-9, and 17-20 for pharmacokinetic assessments for each biomarker and TPV/r (Days 7-9 and 17-20)
- Volunteers must be willing to complete all study-related activities
- Each volunteer must have a valid social security number
- Each volunteer must have acceptable medical history, physical examination and laboratory test
Exclusion
- History or presence of allergy to the study drugs or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation
- Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
- History or diagnosis of any significant medical conditions: Including but not limited to gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hematological, psychiatric, neurological, oncological or hormonal disorders
- Known elevated liver enzymes in past clinical trials with any compound (experimental or marketed)
- Clinically relevant laboratory abnormalities (e.g. Hgb\<11g/dL, Hct\<30g/dL, total cholesterol \>240mg/dL, triglycerides \>500mg/dL, fasting glucose \>130mg/dL, liver function tests \>2.5x upper limit of normal, baseline international normalized ratio \>1.2)
- History of evidence of clinically significant hepatic, cardiac, pulmonary, endocrine, immunological, gastrointestinal, hematological, vascular or collagen disease
- History of alcohol abuse or use of any illicit drugs
- Unable to abstain from more than one beer or alcohol equivalent per day for the duration of the study
- Use of tobacco products and/or history of smoking within the past 2 months
- Pregnant or breast feeding
- Sexually active women of childbearing age who do not use an acceptable barrier method of birth control
- Hypersensitivity to caffeine, warfarin, vitamin K, omeprazole, dextromethorphan, midazolam, tipranavir, ritonavir or their excipients
- Concomitant treatment with other experimental compounds
- Concomitant administration of any prescription or over the counter medications known to alter P450 enzyme or P-gp activity
- Concomitant administration of any prescription or over the counter medications known to be highly dependent on P450 or P-gp for clearance for which elevated plasma concentrations are known to be associated with serious toxicity
- Concomitant administration of any food product known to alter P450 enzyme or P-gp activity such as grapefruit juice, Seville oranges
- Concomitant administration of any drug that could affect bleeding (e.g., aspirin, clopidogrel, ticlopidine, warfarin, heparin, low-molecular weight heparin)
- Concomitant administration of oral contraceptives (may be included with 7-day washout period)
- Concomitant administration of any herbal medications
- Inadequate venous access
- Renal or hepatic insufficiency
- Clinically unacceptable result at the screening physical examination
- Use of investigational medications within 30 days before study entry
- HIV-positive
- Body Mass Index (BMI) \> 30 kg/m²
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT02243553
Start Date
January 1 2006
Last Update
September 18 2014
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