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), drug transporter and CYP probes, immunosuppressants, HIV anti- retrovirals.

Trial Profile

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), drug transporter and CYP probes, immunosuppressants, HIV anti- retrovirals.

Completed
Phase of Trial: Phase I

Latest Information Update: 23 Apr 2017

At a glance

  • Drugs Sofosbuvir/velpatasvir/voxilaprevir (Primary) ; Voxilaprevir (Primary) ; Bictegravir; Ciclosporin; Cobicistat; Dabigatran etexilate; Darunavir; Efavirenz; Elvitegravir; Emtricitabine; Ethinylestradiol/norgestimate; Pravastatin; Rifampicin; Rilpivirine; Rosuvastatin; Tenofovir alafenamide; Tenofovir disoproxil fumarate; Voriconazole
  • Indications Hepatitis C
  • Focus Pharmacokinetics
  • Sponsors Gilead Sciences
  • Most Recent Events

    • 04 Apr 2016 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 11 Feb 2016 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.
    • 30 Oct 2015 Planned End Date changed from 1 Jan 2016 to 1 Mar 2016 as reported by ClinicalTrials.gov.
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