An Open-Label Two-Way Drug-Drug Interaction Study to Assess the Effect of Tenofovir on the Pharmacokinetics of BMS-790052 and the Effect of BMS-790052 on the Pharmacokinetics of Tenofovir in Healthy Subjects
- Conditions
- Hepatitis C10047438viral liver inflammation
- Registration Number
- NL-OMON36725
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 21
Age: 18-49 years, inclusive
BMI: 18.0 - 32.0 kg/m2, inclusive
Women of child bearing potential should use adequate contraception (e.g., double barrier method) until at least 12 weeks after last dose of study medication
- Any significant acute or chronic medical illness (especially renal disease).
- Current or recent (within 3 months of study drug administration) gastrointestinal disease indicated as clinically relevant by the Medical Investigator.
- Any major surgery within 4 weeks of study drug administration.
- Any gastrointestinal surgery that could impact upon the absorption of study drug.
- Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 90 days of study drug administration.
- Blood transfusion within 90 days of study drug administration.
- Inability to tolerate oral medication.
- Inability to swallow oral medication in the form of tablets or capsules.
- Inability to be venipunctured and/or tolerate venous access.
- Smoking more than 5 cigarettes per day.
- History of renal disease including but not limited to acute renal failure and Fanconi syndrome.
- History of pathologic fracture or other significant risk factors for osteoporosis or bone loss.
- Recent (within 6 months of study drug administration) drug or alcohol abuse
- Any other sound medical, psychiatric and/or social reason as determined by the investigator.
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population.
- Positive urine screen for drugs of abuse.
- Positive blood screen for hepatitis C antibody, hepatitis B surface antigen (HBsAg), HIV viral load or HIV-1, -2 antibody
- Serum creatinine > upper limit of normal (ULN).
- History of any significant drug allergy (such as anaphylaxis, hepatotoxicity or rash).
- Pregnancy or lactation (females only).
- Prisoners or subjects who are involuntarily incarcerated.
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacokinetics</p><br>
- Secondary Outcome Measures
Name Time Method <p>Safety</p><br>