Study of the Electrocardiographic Effects of TA-8995

Dyslipidaemia Clinical Trial

Official title:

A Phase I, Single-Centre, Randomised, Placebo and Positive- Controlled, Parallel-Group Study of the Electrocardiographic Effects of TA-8995 in Healthy Male and Female Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02241759
• Other study ID #: TA-8995-04
• Status: Completed
• Phase: Phase 1
• First received: August 20, 2014
• Last updated: February 12, 2015
• Start date: August 2014
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Xention Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A study in healthy males and females to see if a high single dose of TA-8995 has an effect on the ECG QTcF interval.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male or females of non-child bearing potential

Exclusion Criteria:

• Receiving any other drug therapy

• Clinically significant medical history

• Abnormal ECGs or vital signs

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidaemia
• Dyslipidemias

Intervention

Drug:
• TA-8995

• Moxifloxacin

• Placebo

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	Change from baseline in QT interval corrected for heart rate (QTc) for TA-8995 versus placebo		4 days	Yes
Secondary	Relationship between plasma levels of TA-8995 and the QTcF effect		4 days	No