NCT02408055

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

October 3, 2016

Status Verified

September 1, 2016

Enrollment Period

2 months

First QC Date

February 25, 2015

Last Update Submit

September 30, 2016

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (5)

  • AUC of TA-8995

    35 days

  • Mass balance recovery of total radioactivity from excreta for 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

  • Elimination of half-life of radiolabelled TA-8995

    35 days

Secondary Outcomes (1)

  • Number of adverse events

    35 days

Study Arms (1)

Radiolabelled TA-8995

EXPERIMENTAL
Drug: TA-8995

Interventions

TA-8995DRUG
Radiolabelled TA-8995

Eligibility Criteria

Age30 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male subjects

You may not qualify if:

  • Clinically significant abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Clinical Research Unit Ltd

Leeds, LS2 9LH, United Kingdom

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

TA-8995

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ashley Brooks

    Covance

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2015

First Posted

April 3, 2015

Study Start

June 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

October 3, 2016

Record last verified: 2016-09

Locations

GB(1)