drugset / Trial / NCT02533427
Study to Evaluate Effect of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination on the Pharmacokinetics of a Representative Hormonal Contraceptive Medication, Norgestimate/Ethinyl Estradiol
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2015-10-29
- Primary completion
- 2016-03-18
- Completion
- 2016-03-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Norgestimate/ethinyl estradiol | Unknown | — | Oral |
| Subject | SOF/VEL/VOX | Unknown | — | Oral |
| Subject | VOX | Unknown | 100 mg | Oral |