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Bioequivalence Study of Capsule and Tablet Formulations of TA-8995

Primary Purpose

Dyslipidaemia

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
TA-8995
TA-8995
Sponsored by
Xention Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidaemia

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Covance Clinical Research Unit Ltd

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment Period 1

Treatment Period 2

Arm Description

Either 5mg TA-8995 Capsule or Tablet

Either 5mg TA-8995 Capsule or Tablet

Outcomes

Primary Outcome Measures

Area under the plasma concentration versus time curve (AUC) of TA-8995 capsule and tablet formulations
Peak Plasma Concentration (Cmax) of TA-8995 capsule and tablet formulations

Secondary Outcome Measures

Full Information

First Posted
August 12, 2015
Last Updated
January 28, 2016
Sponsor
Xention Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02523391
Brief Title
Bioequivalence Study of Capsule and Tablet Formulations of TA-8995
Official Title
A Phase I, Randomised, Open-label Cross-over Bioequivalence Study of Capsule and Tablet Formulations of TA-8995 in Healthy Male Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidaemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Period 1
Arm Type
Experimental
Arm Description
Either 5mg TA-8995 Capsule or Tablet
Arm Title
Treatment Period 2
Arm Type
Experimental
Arm Description
Either 5mg TA-8995 Capsule or Tablet
Intervention Type
Drug
Intervention Name(s)
TA-8995
Intervention Description
Capsule
Intervention Type
Drug
Intervention Name(s)
TA-8995
Intervention Description
Tablet
Primary Outcome Measure Information:
Title
Area under the plasma concentration versus time curve (AUC) of TA-8995 capsule and tablet formulations
Time Frame
72 hours
Title
Peak Plasma Concentration (Cmax) of TA-8995 capsule and tablet formulations
Time Frame
72 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy males aged 18-55 Body Mass Index (BMI) between 18.0 and 32.0 kg/m2, inclusive Exclusion Criteria: 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.
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

Bioequivalence Study of Capsule and Tablet Formulations of TA-8995

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