ADME Study in Healthy Male Subjects With TA-8995

Dyslipidemia Clinical Trial

Official title:

A Phase I Study to Assess the Mass Balance Recovery, Pharmacokinetics, Metabolism and Excretion of 14C-TA-8995 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02408055
• Other study ID #: TA-8995-07
• Status: Completed
• Phase: Phase 1
• First received: February 25, 2015
• Last updated: September 30, 2016
• Start date: June 2015
• Est. completion date: August 2015

Study information

• Verified date: September 2016
• Source: Xention Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

A study to measure the absorption, metabolism and excretion of a single dose of radiolabelled TA-8995 (10mg) in healthy male subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy male subjects

Exclusion Criteria:

• Clinically significant abnormalities

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• TA-8995

Locations

Country	Name	City	State
United Kingdom	Covance Clinical Research Unit Ltd	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Xention Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC of TA-8995		35 days	No
Primary	Mass balance recovery of total radioactivity from excreta for radiolabelled TA-8995		35 days	No
Primary	Measure the amount of radiolabelled TA-8995 recovered from urine and faeces.		35 days	No
Primary	Measure the levels of major metabolites of TA-8995 in plasma, urine and faeces after oral administration of radiolabelled TA-8995		35 days	No
Primary	Elimination of half-life of radiolabelled TA-8995		35 days	No
Secondary	Number of adverse events		35 days	Yes