Study of the Electrocardiographic Effects of TA-8995

Phase 1

Completed

• Conditions: Dyslipidaemia
• Interventions: Drug: Placebo; Drug: Moxifloxacin; Drug: TA-8995

• Registration Number: NCT02241759
• Lead Sponsor: Xention Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-20
• Study First Submitted QC: 2014-09-12
• Study First Posted: 2014-09-16
• Primary Completion: 2014-11
• Study Completion: 2014-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-12
• Last Update Posted: 2015-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Single oral dose of placebo to TA-8995
Moxifloxacin	Moxifloxacin	Single open-label oral dose of 400mg moxifloxacin
TA-8995	TA-8995	Single oral dose of 150mg TA-8995

Primary Outcome Measures

Name	Time	Method
Change from baseline in QT interval corrected for heart rate (QTc) for TA-8995 versus placebo	4 days

Secondary Outcome Measures

Name	Time	Method
Relationship between plasma levels of TA-8995 and the QTcF effect	4 days

Trial Locations

Locations (1)

Covance Clinical Research Unit Ltd; 🇬🇧 Leeds, United Kingdom