Study of the Electrocardiographic Effects of TA-8995

Phase 1CompletedNCT02241759

Xention Ltd136 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

136

Conditions

Dyslipidaemia

Interventions

TA-8995DRUG

MoxifloxacinDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Covance Clinical Research Unit Ltd

Leeds, United Kingdom

Outcomes

Primary Outcomes

Change from baseline in QT interval corrected for heart rate (QTc) for TA-8995 versus placebo

Time frame: 4 days

Secondary Outcomes

Relationship between plasma levels of TA-8995 and the QTcF effect

Time frame: 4 days

Data from ClinicalTrials.gov

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