Clinical Trials Logo
  1. Home
  2. Hepatic Impairment
  3. NCT01271387

Pharmacokinetics of Tasimelteon in Subjects With Mild or Moderate Hepatic Impairment

Hepatic Impairment Clinical Trial

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

Clinical Trial Summary

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 in individuals with mild or moderate liver disease compared to individuals who have normal liver function.

Clinical Trial Description

The study will employ an open-label, parallel-group design. Up to 32 subjects will be enrolled in 3 groups: Group 1 will consist of 8 subjects with mild hepatic impairment; Group 2 will consist of 8 subjects with moderate hepatic impairment; Group 3 will consist of up to 16 healthy subjects matched by gender, age, smoking status, and body mass index, to Groups 1 and/or 2. For each group, there will be a 21-day screening period, a baseline period, a single-dose treatment period with an on-site observation period of 36 hours, and a study completion evaluation conducted after the last PK blood sample is drawn. Each subject will receive a single 20-mg dose of tasimelteon, after which safety assessments will be performed. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01271387
Study type Interventional
Source Vanda Pharmaceuticals
Contact
Status Completed
Phase Phase 1
Start date January 2011
Completion date August 2011
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05009680 - A Single and Repeat Dose Trial in Participants With Hepatic Impairment Phase 1/Phase 2
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Terminated NCT05517226 - Pharmacokinetics of Cotadutide in Participants With Hepatic Impairment Phase 1
Completed NCT03983161 - A Pharmacokinetics and Tolerability Study of Fedratinib in Subjects With Moderate and Severe Hepatic Impairment Phase 1
Completed NCT04546789 - Effect of Hepatic Impairment on M2951 (BTK Inhibitor) PK Phase 1
Completed NCT03282513 - A Study of AG-120 (Ivosidenib) in Subjects With Mild or Moderate Hepatic Impairment or Normal Hepatic Function Phase 1
Recruiting NCT05976321 - A Study of TAK-279 in Adults With or Without Liver Damage Phase 1
Completed NCT04473664 - A Study of Quizartinib Pharmacokinetics in Participants With Moderate Hepatic Impairment Phase 1
Recruiting NCT05484206 - Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434 Phase 1
Completed NCT03290443 - A Study to Assess the Pharmacokinetics of Enasidenib (CC-90007) in Subjects With Moderate and Severe Hepatic Impairment. Phase 1
Completed NCT02244827 - Pharmacokinetics of WCK 2349 In Patients With Hepatic Impairment Phase 1
Completed NCT02245243 - Pharmacokinetics of Delafloxacin in Subjects With and Without Hepatic Impairment Phase 1
Completed NCT02004587 - Influence of Hepatic Impairment on Pharmacokinetic (PK) and Pharmacodynamic (PD) of Gemigliptin PK and PD After Multiple Oral Doses in Healthy White Volunteers Phase 1
Completed NCT01621633 - A Study of LCZ696 in Subjects With Mild and Moderate Hepatic Impairment Compared With Normal Healthy Volunteers Phase 2
Completed NCT01493869 - Study to Assess the Pharmacokinetics of Cabozantinib (XL184) in Hepatic Impaired Adult Subjects Phase 1
Completed NCT04482270 - A Study to Investigate the Effect of Mild and Moderate Hepatic Impairment on the Safety and Tolerability of Fezolinetant Compared to Participants With Normal Hepatic Function Phase 1
Completed NCT02115347 - Pharmacokinetics, Safety, and Tolerability of Ertugliflozin (MK-8835/PF-04971729) in Participants With Hepatic Impairment and in Healthy Participants (MK-8835-014) Phase 1
Recruiting NCT04950764 - An Open-Label Study Following Oral Dosing of Seladelpar to Subjects With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI) Phase 1
Completed NCT06161259 - Pharmacokinetics of Leritrelvir(RAY1216) in Participants With Hepatic Impairment Phase 1
Completed NCT05409911 - A Study to Assess S-217622 in Participants With Mild and Moderate Hepatic Impairment and Healthy Control Participants Phase 1