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Completed Phase 1 Interventional Accepts healthy volunteers

Pharmacokinetics of Tasimelteon in Subjects With Renal Impairment and Matched Control Subjects With Relatively Normal Renal Function

ClinicalTrials.gov ID: NCT01526746

Public ClinicalTrials.gov record NCT01526746. 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 Sep 3, 2026, 7:21 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-Dose, Parallel-Group Study to Compare the Pharmacokinetics of Tasimelteon in Subjects With Renal Impairment With That in Matched Control Subjects With Relatively Normal Renal Function

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this research study is to understand whether there is any difference in the amount of tasimelteon (including its breakdown products) in the blood of individuals with severe renal impairment compared to individuals who have normal renal function. The safety and tolerability of tasimelteon will also be assessed throughout this study.

Study identification

NCT ID
NCT01526746
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Vanda Pharmaceuticals
Industry
Enrollment
32 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 79 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
Jan 31, 2012
Primary completion
May 31, 2012
Completion
May 31, 2012
Last update posted
Feb 16, 2014

2012

United States locations

U.S. sites
3
U.S. states
2
U.S. cities
3
Facility City State ZIP Site status
Clinical Pharmacology of Miami, Inc. Miami Florida 33014
Orlando Clinical Research Center Orlando Florida 32809
DaVita Clinical Research Minneapolis Minnesota

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 NCT01526746, 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 Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01526746 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →