ADME Study in Healthy Male Subjects With TA-8995

Phase 1

Completed

• Conditions: Dyslipidemia
• Interventions: Drug: TA-8995

• Registration Number: NCT02408055
• Lead Sponsor: Xention Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-25
• Study First Submitted QC: 2015-03-30
• Study First Posted: 2015-04-03
• Study Start: 2015-06
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-30
• Last Update Posted: 2016-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

Inclusion Criteria

• Healthy male subjects

Exclusion Criteria

• Clinically significant abnormalities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiolabelled TA-8995	TA-8995	-

Primary Outcome Measures

Name	Time	Method
Mass balance recovery of total radioactivity from excreta for radiolabelled TA-8995	35 days
AUC of TA-8995	35 days
Measure the amount of radiolabelled TA-8995 recovered from urine and faeces.	35 days
Measure the levels of major metabolites of TA-8995 in plasma, urine and faeces after oral administration of radiolabelled TA-8995	35 days
Elimination of half-life of radiolabelled TA-8995	35 days

Secondary Outcome Measures

Name	Time	Method
Number of adverse events	35 days

Trial Locations

Locations (1)

Covance Clinical Research Unit Ltd; 🇬🇧 Leeds, United Kingdom