ADME Study in Healthy Male Subjects With TA-8995

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02408055

Enrollment

Registered

2015-04-03

Start date

2015-06-30

Completion date

2015-08-31

Last updated

2016-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia

Brief summary

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

Interventions

DRUGTA-8995

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

30 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male subjects

Exclusion criteria

* Clinically significant abnormalities

Design outcomes

Primary

Measure	Time frame
Elimination of half-life of radiolabelled 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
AUC of TA-8995	35 days
Mass balance recovery of total radioactivity from excreta for radiolabelled TA-8995	35 days

Secondary

Measure	Time frame
Number of adverse events	35 days

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026