Study of the Electrocardiographic Effects of TA-8995

Xention

Status and phase: Completed; Phase 1

Conditions: Dyslipidaemia

Treatments: Drug: Moxifloxacin; Drug: Placebo; Drug: TA-8995

Study type: Interventional

Funder types: Industry

Identifiers

NCT02241759

TA-8995-04

Details and patient eligibility

About

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.

Enrollment: 136 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

136 participants in 3 patient groups

TA-8995

Experimental group

Description:

Single oral dose of 150mg TA-8995

Treatment:

Drug: TA-8995

Placebo

Experimental group

Description:

Single oral dose of placebo to TA-8995

Treatment:

Drug: Placebo

Moxifloxacin

Active Comparator group

Description:

Single open-label oral dose of 400mg moxifloxacin

Treatment:

Drug: Moxifloxacin