Back to resultsADME Study in Healthy Male Subjects With TA-8995
Primary Purpose
Dyslipidemia
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
TA-8995
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemia
Eligibility Criteria
Inclusion Criteria:
- Healthy male subjects
Exclusion Criteria:
- Clinically significant abnormalities
Sites / Locations
- Covance Clinical Research Unit Ltd
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Radiolabelled TA-8995
Arm Description
Outcomes
Primary Outcome Measures
AUC of TA-8995
Mass balance recovery of total radioactivity from excreta for radiolabelled TA-8995
Measure the amount of radiolabelled TA-8995 recovered from urine and faeces.
Measure the levels of major metabolites of TA-8995 in plasma, urine and faeces after oral administration of radiolabelled TA-8995
Elimination of half-life of radiolabelled TA-8995
Secondary Outcome Measures
Number of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02408055
Brief Title
ADME Study in Healthy Male Subjects With TA-8995
Official Title
A Phase I Study to Assess the Mass Balance Recovery, Pharmacokinetics, Metabolism and Excretion of 14C-TA-8995 in Healthy Male Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xention Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A study to measure the absorption, metabolism and excretion of a single dose of radiolabelled TA-8995 (10mg) in healthy male subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radiolabelled TA-8995
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
TA-8995
Primary Outcome Measure Information:
Title
AUC of TA-8995
Time Frame
35 days
Title
Mass balance recovery of total radioactivity from excreta for radiolabelled TA-8995
Time Frame
35 days
Title
Measure the amount of radiolabelled TA-8995 recovered from urine and faeces.
Time Frame
35 days
Title
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
Title
Elimination of half-life of radiolabelled TA-8995
Time Frame
35 days
Secondary Outcome Measure Information:
Title
Number of adverse events
Time Frame
35 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male subjects
Exclusion Criteria:
Clinically significant abnormalities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashley Brooks
Organizational Affiliation
Covance
Official's Role
Principal Investigator
Facility Information:
Facility Name
Covance Clinical Research Unit Ltd
City
Leeds
ZIP/Postal Code
LS2 9LH
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
ADME Study in Healthy Male Subjects With TA-8995
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