NCT02523391

Brief Summary

The purpose of this study is to compare the pharmacokinetics of capsule and tablet formulations of TA-8995 in healthy male subjects aged 18 to 55 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 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

Study Start

First participant enrolled

July 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 12, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

January 29, 2016

Status Verified

January 1, 2016

Enrollment Period

4 months

First QC Date

August 12, 2015

Last Update Submit

January 28, 2016

Conditions

Dyslipidaemia

Outcome Measures

Primary Outcomes (2)

  • Area under the plasma concentration versus time curve (AUC) of TA-8995 capsule and tablet formulations

    72 hours

  • Peak Plasma Concentration (Cmax) of TA-8995 capsule and tablet formulations

    72 hours

Study Arms (2)

Treatment Period 1

EXPERIMENTAL

Either 5mg TA-8995 Capsule or Tablet

Drug: TA-8995

Treatment Period 2

EXPERIMENTAL

Either 5mg TA-8995 Capsule or Tablet

Drug: TA-8995

Interventions

TA-8995DRUG

Capsule

Treatment Period 1Treatment Period 2

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males aged 18-55
  • Body Mass Index (BMI) between 18.0 and 32.0 kg/m2, inclusive

You may not qualify if:

  • Subject has a known hypersensitivity to any of the inactive ingredients of the study treatments.
  • Subject has any other condition which, in the Investigator's opinion will interfere with the study.
  • Subjects who are still participating in another clinical study (eg, attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) within 3 months or 5 half-lives (whichever is longer) prior to the first dose in this study.

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 Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2015

First Posted

August 14, 2015

Study Start

July 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

January 29, 2016

Record last verified: 2016-01

Locations

GB(1)