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A Preliminary Drug Drug Interaction Study With TA-8995

NCT ID: NCT02124954

Last Updated: 2016-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-07-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Pharmacokinetic Interactions

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Digoxin with/without TA-8995

Digoxin with/without TA-8995

Group Type EXPERIMENTAL

TA-8995

Intervention Type DRUG

Digoxin

Intervention Type DRUG

Midazolam with/without TA-8995

Midazolam with/without TA-8995

Group Type EXPERIMENTAL

TA-8995

Intervention Type DRUG

Midazolam

Intervention Type DRUG

Interventions

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TA-8995

Intervention Type DRUG

Midazolam

Intervention Type DRUG

Digoxin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects

Exclusion Criteria

* Receiving any other drug therapy
* Clinically significant medical history
* Abnormal laboratory results or ECGs
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Xention Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ashley Brooks

Role: PRINCIPAL_INVESTIGATOR

Covance

Locations

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Covance

Leeds, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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TA-8995-05

Identifier Type: -

Identifier Source: org_study_id

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