A Preliminary Drug Drug Interaction Study With TA-8995 | NCT02124954

Studies
A Preliminary Drug Drug Interaction Study With TA-8995

NCT02124954

Sponsor

Xention Ltd

Status

Completed

Last Update Posted

Oct 3, 2016Estimated

Enrollment

18Actual

Phase

Phase 1

Conditions

Pharmacokinetic Interactions

Interventions

TA-8995
Midazolam
Digoxin

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

Sep 2016

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

May 2014

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Apr 17, 2014

First Submission Date that Met QC Criteria

Apr 24, 2014

First Posted Date

Apr 28, 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

Sep 30, 2016

Last Update Posted Date

Oct 3, 2016Estimated

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 to look at how multiple doses of TA-8995 affect blood levels and rate of removal of other drugs, using single doses of digoxin and midazolam as examples, to see if there are any potential drug interactions that might affect patients in future studies. The study will examine whether co-administration of TA-8995 affects the pharmacokinetics of digoxin and midazolam measured by area under the curve (AUC).

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

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Digoxin with/without TA-8995	Experimental	Digoxin with/without TA-8995	Drug: TA-8995 Drug: Digoxin
Midazolam with/without TA-8995	Experimental	Midazolam with/without TA-8995	Drug: TA-8995 Drug: Midazolam

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TA-8995	Drug		Digoxin with/without TA-8995 Midazolam with/without TA-8995
Midazolam

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasma concentrations of TA-8995, midazolam and digoxin		Over 16 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Healthy male subjects

Exclusion Criteria

Receiving any other drug therapy
Clinically significant medical history
Abnormal laboratory results or ECGs

Accepts Healthy Volunteers

Yes

Sex

Male

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		Leeds		LS2 9LH	United Kingdom

Intervention Browse Module

MeSH Terms

ID	Term
C000597751	TA-8995
D008874	Midazolam
D004077	Digoxin

Ancestor Terms

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

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Browse Branches

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