Hepatitis C viral liver inflammation
Conditions
Interventions
Active substance: BMS-790052, tenofovir
Sponsors
Bristol-Myers Squibb
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety | — |
Countries
Netherlands
Outcome results
None listed