Back to resultsStudy of the Electrocardiographic Effects of TA-8995
Primary Purpose
Dyslipidaemia
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
TA-8995
Moxifloxacin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidaemia
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
Sites / Locations
- Covance Clinical Research Unit Ltd
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
TA-8995
Placebo
Moxifloxacin
Arm Description
Single oral dose of 150mg TA-8995
Single oral dose of placebo to TA-8995
Single open-label oral dose of 400mg moxifloxacin
Outcomes
Primary Outcome Measures
Change from baseline in QT interval corrected for heart rate (QTc) for TA-8995 versus placebo
Secondary Outcome Measures
Relationship between plasma levels of TA-8995 and the QTcF effect
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02241759
Brief Title
Study of the Electrocardiographic Effects of TA-8995
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xention Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidaemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TA-8995
Arm Type
Experimental
Arm Description
Single oral dose of 150mg TA-8995
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Single oral dose of placebo to TA-8995
Arm Title
Moxifloxacin
Arm Type
Active Comparator
Arm Description
Single open-label oral dose of 400mg moxifloxacin
Intervention Type
Drug
Intervention Name(s)
TA-8995
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change from baseline in QT interval corrected for heart rate (QTc) for TA-8995 versus placebo
Time Frame
4 days
Secondary Outcome Measure Information:
Title
Relationship between plasma levels of TA-8995 and the QTcF effect
Time Frame
4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashley Brooks
Organizational Affiliation
Covance
Official's Role
Principal Investigator
Facility Information:
Facility Name
Covance Clinical Research Unit Ltd
City
Leeds
ZIP/Postal Code
LS2 9LH
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Study of the Electrocardiographic Effects of TA-8995
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