Skip to main content
OpenTrials
Completed

NCT Number: NCT02408055

ADME Study in Healthy Male Subjects With TA-8995

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit Ltd

Leeds, LS2 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male subjects

Exclusion criteria

  • Clinically significant abnormalities

Treatment and study plan

TA-8995

Drug

Primary outcomes

  1. AUC of TA-8995

    Time frame: 35 days

  2. Mass balance recovery of total radioactivity from excreta for radiolabelled TA-8995

    Time frame: 35 days

  3. Measure the amount of radiolabelled TA-8995 recovered from urine and faeces.

    Time frame: 35 days

  4. Measure the levels of major metabolites of TA-8995 in plasma, urine and faeces after oral administration of radiolabelled TA-8995

    Time frame: 35 days

  5. Elimination of half-life of radiolabelled TA-8995

    Time frame: 35 days

Secondary outcomes

  1. Number of adverse events

    Time frame: 35 days

Sponsors and collaborators

Lead sponsor

Xention Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 3, 2015
Registry last updated
Oct 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.