Study of the Electrocardiographic Effects of TA-8995

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02241759

Enrollment

136

Registered

2014-09-16

Start date

2014-08-31

Completion date

2014-12-31

Last updated

2015-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidaemia

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.

Interventions

DRUGTA-8995

DRUGMoxifloxacin

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Relationship between plasma levels of TA-8995 and the QTcF effect	4 days

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026