ADME Study in Healthy Male Subjects With TA-8995

September 30, 2016 updated by: Xention Ltd

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Leeds, United Kingdom, LS2 9LH
        • Covance Clinical Research Unit Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male subjects

Exclusion Criteria:

  • Clinically significant abnormalities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Radiolabelled TA-8995
Drug: TA-8995

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUC of TA-8995
Time Frame: 35 days
35 days
Mass balance recovery of total radioactivity from excreta for radiolabelled TA-8995
Time Frame: 35 days
35 days
Measure the amount of radiolabelled TA-8995 recovered from urine and faeces.
Time Frame: 35 days
35 days
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
35 days
Elimination of half-life of radiolabelled TA-8995
Time Frame: 35 days
35 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of adverse events
Time Frame: 35 days
35 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xention Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (ACTUAL)

August 1, 2015

Study Completion (ACTUAL)

August 1, 2015

Study Registration Dates

First Submitted

February 25, 2015

First Submitted That Met QC Criteria

March 30, 2015

First Posted (ESTIMATE)

April 3, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

October 3, 2016

Last Update Submitted That Met QC Criteria

September 30, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TA-8995-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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