The purpose of this study is to determine the change from baseline in HCV Ribonucleic acid (RNA) on Day 4 following three days of dosing with BMS-929075 in chronically genotype subtype 1a and 1b HCV infected subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Oral Suspension, ≤ 25 mg, Once daily, 3 days
Oral Suspension, ≤ 100 mg, Once daily, 3 days
Oral Suspension, ≤ 400 mg, Once daily, 3 days
Local Institution
Herston, Queensland, Australia
Local Institution
Adelaide, South Australia, Australia
Local Institution
Melbourne, Victoria, Australia
HCV RNA level on Day 4
Time frame: Within 4 days after the first dose
Maximum decrease from baseline in plasma HCV RNA levels during the period from Day 1 to Day 28
Time frame: Days 1-28
Time course of the change from baseline in plasma HCV RNA levels and the time of maximum decrease during the period of Day 1 through Day 28
Time frame: Days 1-28
Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests
Time frame: Days 1-28 (with SAE from screening to Day 30)
Maximum observed plasma concentration (Cmax) of BMS-929075 derived from plasma concentration versus time
Time frame: Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h)
Minimum observed plasma concentration (Cmin) of BMS-929075 derived from plasma concentration versus time
Time frame: Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h)
Trough observed plasma concentration (Ctrough) of BMS-929075 derived from plasma concentration versus time
Time frame: Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h)
Time of maximum observed plasma concentration (Tmax) of BMS-929075 derived from plasma concentration versus time
Time frame: Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h)
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Oral Suspension, (≤ 800 mg, Once daily) OR (≤ 400 mg, Twice daily), 3 days
Oral Suspension, 0 mg, Once daily, 3 days
Oral Suspension, 0 mg, (Once daily for ≤ 800 mg group) OR (Twice daily for ≤ 400 mg group), 3 days
Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-929075 derived from plasma concentration versus time
Time frame: Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h)
Plasma half-life (T-HALF) of BMS-929075 derived from plasma concentration versus time
Time frame: Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h)
Protein Binding (PB) of BMS-929075 derived from plasma concentration versus time
Time frame: Day 3 (0h and 2h)
Fraction of free drug in plasma (fu) of BMS-929075 derived from plasma concentration versus time
Time frame: Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h)
The relationship between antiviral activity and measures of exposure to BMS-929075
Time frame: Days 1-6