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Completed Phase 1 Interventional Accepts healthy volunteers

A Study to Assess the Effect Tasimelteon on the Cytochrome P450 3A4 and 2C8 Enzymes in Healthy Subjects

ClinicalTrials.gov ID: NCT01402076

Public ClinicalTrials.gov record NCT01402076. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jun 26, 2026, 8:39 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-Label, Single-Sequence Study to Assess the Effect of Multiple Doses of Tasimelteon on the Cytochrome P450 3A4 and 2C8 Enzymes Using Midazolam and Rosiglitazone as Substrates in Healthy Subjects

Study identification

NCT ID
NCT01402076
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Vanda Pharmaceuticals
Industry
Enrollment
24 participants

Conditions and interventions

Interventions

  • Tasimelteon Drug
  • Rosiglitazone Drug
  • Midazolam Drug

Drug

Eligibility (public fields only)

Age range
18 Years to 55 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 31, 2011
Primary completion
Jul 31, 2011
Completion
Jul 31, 2011
Last update posted
Feb 16, 2014

2011

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Bio-Kinetic Clinical Applications Springfield Missouri 65802

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01402076, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 16, 2014 · Synced Jun 26, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01402076 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →