Pharmacokinetics of Tasimelteon Alone and in Combination With a CYP3A4 Inhibitor, Ketoconazole, or a CYP3A4 Inducer, Rifampin.
An Open-label, Single-sequence Study in Two Cohorts of Healthy Subjects to Evaluate the Single-dose Pharmacokinetics of Tasimelteon Alone and in Combination With a CYP3A4 Inhibitor, Ketoconazole, or a CYP3A4 Inducer, Rifampin.
Sponsor: Vanda Pharmaceuticals
Listed as NCT01637636, this PHASE1 trial focuses on Healthy and remains completed. Sponsored by Vanda Pharmaceuticals, it has been updated 6 times since 2012, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
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
▶ Show 1 earlier version
-
Jan 2017 — Feb 2017 [monthly]
Completed PHASE1
First recorded
Jun 2012
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Vanda Pharmaceuticals
For direct contact, visit the study record on ClinicalTrials.gov .