Completed PHASE1 INTERVENTIONAL 3-arm NCT01271387

Pharmacokinetics of Tasimelteon in Subjects With Mild or Moderate Hepatic Impairment

An Open-Label, Single-Dose, Parallel-Group Study to Compare the Pharmacokinetics of Tasimelteon With That in Matched Healthy Control Subjects

Sponsor: Vanda Pharmaceuticals

Conditions Hepatic Impairment

Interventions tasimelteon

Updated 6 times since 2017 Last updated: Feb 14, 2014 Started: Jan 31, 2011 Primary completion: Aug 31, 2011 Completion: Aug 31, 2011

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

Listed as NCT01271387, this PHASE1 trial focuses on Hepatic Impairment and remains completed. Sponsored by Vanda Pharmaceuticals, it has been updated 6 times since 2011, 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

Jan 2011

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Vanda Pharmaceuticals

Data source: Vanda Pharmaceuticals

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

Study Locations

• Orlando, United States