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

A Phase 1, Open-Label, Drug Interaction Study Evaluating the Effect of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination on the Pharmacokinetics of a Representative Hormonal Contraceptive Medication, Norgestimate/Ethinyl Estradiol

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• HCV Infection

Interventions

Type	Name	Description
DRUG	SOF/VEL/VOX	400/100/100 mg FDC tablet administered orally once daily
DRUG	VOX	100 mg tablet administered orally once daily
DRUG	Norgestimate/ethinyl estradiol	Norgestimate 0.180 mg/0.215 mg/0.25 mg/ethinyl estradiol 0.025 mg tablet administered orally once daily according to the package insert

Timeline

• Start date: 2015-10-29
• Primary completion: 2016-03-18
• Completion: 2016-03-18
• First posted: 2015-08-26
• Last updated: 2020-09-02
• Results posted: 2020-09-02

Locations

1 site across 1 country: New Zealand

Regulatory

• FDA-regulated drug study