Bioequivalence Study of Capsule and Tablet Formulations of TA-8995

Dyslipidaemia Clinical Trial

Official title:

A Phase I, Randomised, Open-label Cross-over Bioequivalence Study of Capsule and Tablet Formulations of TA-8995 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02523391
• Other study ID #: TA-8995-08
• Status: Completed
• Phase: Phase 1
• First received: August 12, 2015
• Last updated: January 28, 2016
• Start date: July 2015
• Est. completion date: November 2015

Study information

• Verified date: January 2016
• Source: Xention Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidaemia
• Dyslipidemias

Intervention

Drug:
• TA-8995
Capsule
• TA-8995
Tablet

Locations

Country	Name	City	State
United Kingdom	Covance Clinical Research Unit Ltd	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Xention Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration versus time curve (AUC) of TA-8995 capsule and tablet formulations		72 hours	No
Primary	Peak Plasma Concentration (Cmax) of TA-8995 capsule and tablet formulations		72 hours	No