The purpose of this study is to evaluate the effect of steady-state concentrations of odalasvir (ODV), AL-335 and the combination of the 3-direct-acting anti-viral agents (3-DAA) ODV, AL-335, and simeprevir (SMV) on the single-dose pharmacokinetic (PK) of drospirenone and ethinylestradiol in healthy female participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
24
Each tablet contains 3 mg drospirenone and 0.02 mg ethinylestradiol to be taken orally on Days 1, 6, 25, and 32.
AL-335 (800 mg) tablet once daily on Days 5-7 and then on Days 26-32 (as a component of 3-DAA combination) to be taken orally.
ODV 25 mg tablet once daily on Days 12-25 and then on Days 26-32 (as a component of 3-DAA combination) to be taken orally.
Unnamed facility
Overland Park, Kansas, United States
Maximum Observed Analyte Concentration (Cmax) of Drospirenone
Cmax is the maximum observed analyte concentration.
Time frame: Day 1, 7, 25 and 32: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours postdose
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of Drospirenone
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
Time frame: Day 1, 7, 25 and 32: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours postdose
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Drospirenone
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(0-last) and C(last)/lambda(z); wherein AUC(0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Time frame: Day 1, 7, 25 and 32: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours postdose
Maximum Observed Plasma Concentration (Cmax) of Ethinylestradiol
Cmax is the maximum observed analyte concentration.
Time frame: Day 1, 7, 25 and 32: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours postdose
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of Ethinylestradiol
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
Time frame: Day 1, 7, 25 and 32: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours postdose
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Ethinylestradiol
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SMV 75 mg capsule as a component of 3-DAA combination to be taken orally on Days 26-32.
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(0-last) and C(last)/lambda(z); wherein AUC(0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Time frame: Day 1, 7, 25 and 32: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours postdose
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: Approximately 4 Months