CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 15 enrolled
Drug / intervention
SOF/VEL/VOX +2 moredrug
Likely dose
SOF/VEL/VOX 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02533427
NCT02533427Phase 1Completed
CompareCT.gov

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

Gilead Sciences·interventional·Posted Aug 26, 2015·Updated Sep 2, 2020

In Brief

A Phase 1 clinical trial evaluating SOF/VEL/VOX, VOX, and 1 other intervention for HCV Infection. Completed, enrolled 15 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHCV Infection
CountriesNew Zealand
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 26, 2015
Enrollment StartOct 29, 2015
Primary CompletionMar 18, 2016
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 10.8 years ago

Interventions

SOF/VEL/VOXdrug

400/100/100 mg FDC tablet administered orally once daily

VOXdrug

100 mg tablet administered orally once daily

Norgestimate/ethinyl estradioldrug

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