Study of the Electrocardiographic Effects of TA-8995 | NCT02241759

Studies
Study of the Electrocardiographic Effects of TA-8995

NCT02241759

Sponsor

Xention Ltd

Status

Completed

Last Update Posted

Feb 16, 2015Estimated

Enrollment

136Actual

Phase

Phase 1

Conditions

Dyslipidaemia

Interventions

TA-8995
Moxifloxacin
Placebo

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Nov 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Aug 20, 2014

First Submission Date that Met QC Criteria

Sep 12, 2014

First Posted Date

Sep 16, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2015

Last Update Posted Date

Feb 16, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

136Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
TA-8995	Drug		TA-8995
Moxifloxacin

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ashley Brooks	Covance	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Covance Clinical Research Unit Ltd		Leeds		LS2 9LH	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D050171	Dyslipidemias

Ancestor Terms

ID	Term
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000597751	TA-8995
D000077266	Moxifloxacin

Ancestor Terms

ID	Term
D024841	Fluoroquinolones
D042462	4-Quinolones
D015363	Quinolones
D011804	Quinolines

Browse Leaves

Not provided

Browse Branches

Not provided