Completed PHASE1 INTERVENTIONAL 1-arm NCT02885454

To Evaluate the Effects of Odalasvir and AL-335 With Simeprevir on the Single-Dose Pharmacokinetics of Ethinylestradiol and Drospirenone in Healthy Female Participants

A Phase 1, Open-label Study in Healthy Female Subjects to Investigate the Effects of Odalasvir and AL-335 at Steady-state, Given as Single Agents and in Combination With Simeprevir, on the Single-dose Pharmacokinetics of Ethinylestradiol and Drospirenone

Sponsor: Janssen Research & Development, LLC

Conditions Healthy

Interventions AL-335 Drospirenone/ethinylestradiol Odalasvir (ODV) Simeprevir (SMV)

Updated 6 times since 2017 Last updated: Jan 20, 2017 Started: Aug 31, 2016 Primary completion: Dec 31, 2016 Completion: Dec 31, 2016

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Healthy and is currently completed. Janssen Research & Development, LLC leads this study, which shows 6 recorded versions since 2016 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1
Feb 2017 — Jun 2018 [monthly]

Completed PHASE1

Status: Active Not Recruiting → Completed

▶ Show 1 earlier version

Jan 2017 — Feb 2017 [monthly]

Active Not Recruiting PHASE1

First recorded

Aug 2016

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Janssen Research & Development, LLC

Data source: Janssen Research & Development, LLC

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Overland Park, United States