Pharmacokinetics of Tasimelteon Alone and in Combination With CYP1A2 Inhibitor, Fluvoxamine
Summary
The purpose of this research study is to evaluate whether administration of a CYP1A2 inhibitor affects the single-dose pharmacokinetics of tasimelteon and its metabolites. The safety and tolerability of tasimelteon will also be assessed throughout the study.
Study Design
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Conditions
Healthy Volunteers
Intervention
Tasimelteon, Fluvoxamine
Location
Bio-Kinetic Clinical Applications
Springfield
Missouri
United States
65802
Status
Completed
Source
Vanda Pharmaceuticals
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01540500
- Information obtained from ClinicalTrials.gov on May 08, 2012
Medical and Biotech [MESH] Definitions
Fluvoxamine
A selective serotonin reuptake inhibitor. It is effective in the treatment of depression, obsessive-compulsive disorders, anxiety, panic disorders, and alcohol amnestic disorders.
Hospital Volunteers
Individuals who donate their services to the hospital.
Patient Escort Service
A special service provided by volunteers to accompany patients who need help in moving about the health facility.
Red Cross
International collective of humanitarian organizations led by volunteers and guided by its Congressional Charter and the Fundamental Principles of the International Red Cross Movement, to provide relief to victims of disaster and help people prevent, prepare for, and respond to emergencies.
Clinical Trial, Phase Ii
Work that is a report of a pre-planned, usually controlled, clinical study of the safety and efficacy of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques based on several hundred volunteers, including a limited number of patients, and conducted over a period of about two years in either the United States or a foreign country.
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