Study to Evaluate Effect of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination on the Pharmacokinetics of a Representative Hormonal Contraceptive Medication, Norgestimate/Ethinyl Estradiol

• Status: Completed
• Trial end date: 2016-03-18
• Target enrollment: 0
• Participant gender: Female

Summary

This study will evaluate the effect of sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) fixed-dose combination (FDC) + voxilaprevir on the pharmacokinetics (PK) of a representative hormonal contraceptive medication, norgestimate/ethinyl estradiol (Ortho Tri-Cyclen® Lo (OC)) and will assess the effect of norgestimate/ethinyl estradiol on the PK of SOF/VEL/VOX+VOX.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Contraceptive Agents; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Norgestimate; Norgestimate, ethinyl estradiol drug combination; Norgestrel; Polyestradiol phosphate; Sofosbuvir

Criteria

Inclusion Criteria:

• Premenopausal female

• Must have a calculated body mass index (BMI) ≥ 19.0 and ≤ 30.0 kg/m^2 at screening

• Must have a negative serum pregnancy test at screening and urine pregnancy test at Day -1

• Be willing and able to comply with all study requirements.

Exclusion Criteria:

• Lactating female

• Have a history of any of the following:

• Significant drug sensitivity or drug allergy (such as anaphylaxis or hepatoxicity)

• Known hypersensitivity to the study drugs, the metabolites or formulation excipients

• Believed, by the study investigator, to be inappropriate for study participation for any reason