A Phase 1, Open-label, Fixed-sequence Study to Investigate the Effects of EDP 305 on the Pharmacokinetics of a Combined Oral Contraceptive in Healthy Adult Female Subjects
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
43
Subjects will receive EDP-305 on on Days 11 through 21 of cycle 3
Subjects will receive active Oral Contraceptive on Days 1-21 and inert OC on Days 22-28 of cycles 1, 2 and 3
Covance Clinical Research Unit
Madison, Wisconsin, United States
Area under the plasma concentration-time (AUC0-τ) curve for OC with and without coadministration with EDP-305
Time frame: Day 21 (cycle 2 and cycle 3)
Cmax for OC with and without coadministration with EDP-305
Time frame: Day 21 (cycle 2 and cycle 3)
Area under the plasma concentration-time (AUC0-τ) curve for EDP-305 when coadministration with OC
Time frame: Days 14, 20-22 (cycle 3)
Cmax for EDP-305 when coadministration with OC
Time frame: Days 14, 20-22 (cycle 3)
Safety measured by adverse events
Time frame: Approximately 91 days
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