A Preliminary Drug Drug Interaction Study With TA-8995

Xention Ltd18 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

Pharmacokinetic Interactions

Interventions

TA-8995DRUG

MidazolamDRUG

DigoxinDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria * Healthy male subjects Exclusion Criteria * Receiving any other drug therapy * Clinically significant medical history * Abnormal laboratory results or ECGs

Locations (1)

Covance

Leeds, United Kingdom

Outcomes

Primary Outcomes

Plasma concentrations of TA-8995, midazolam and digoxin

Time frame: Over 16 days

Data from ClinicalTrials.gov

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