NCT02241759

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2014

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 16, 2015

Status Verified

February 1, 2015

Enrollment Period

3 months

First QC Date

August 20, 2014

Last Update Submit

February 12, 2015

Conditions

Dyslipidaemia

Outcome Measures

Primary Outcomes (1)

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

    4 days

Secondary Outcomes (1)

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

    4 days

Study Arms (3)

TA-8995

EXPERIMENTAL

Single oral dose of 150mg TA-8995

Drug: TA-8995

Placebo

EXPERIMENTAL

Single oral dose of placebo to TA-8995

Drug: Placebo

Moxifloxacin

ACTIVE COMPARATOR

Single open-label oral dose of 400mg moxifloxacin

Drug: Moxifloxacin

Interventions

TA-8995DRUG
TA-8995
MoxifloxacinDRUG
Moxifloxacin
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male or females of non-child bearing potential

You may not qualify if:

  • Receiving any other drug therapy
  • Clinically significant medical history
  • Abnormal ECGs or vital signs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Clinical Research Unit Ltd

Leeds, LS2 9LH, United Kingdom

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

TA-8995Moxifloxacin

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Ashley Brooks

    Covance

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2014

First Posted

September 16, 2014

Study Start

August 1, 2014

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

February 16, 2015

Record last verified: 2015-02

Locations

GB(1)