A Preliminary Drug Drug Interaction Study With TA-8995

Phase 1

Completed

• Conditions: Pharmacokinetic Interactions
• Interventions: Drug: TA-8995; Drug: Digoxin; Drug: Midazolam

• Registration Number: NCT02124954
• Lead Sponsor: Xention Ltd

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 available

Study Timeline

• Study First Submitted: 2014-04-17
• Study First Submitted QC: 2014-04-24
• Study First Posted: 2014-04-28
• Study Start: 2014-05
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-30
• Last Update Posted: 2016-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Digoxin with/without TA-8995	TA-8995	Digoxin with/without TA-8995
Midazolam with/without TA-8995	TA-8995	Midazolam with/without TA-8995
Digoxin with/without TA-8995	Digoxin	Digoxin with/without TA-8995
Midazolam with/without TA-8995	Midazolam	Midazolam with/without TA-8995

Primary Outcome Measures

Name	Time	Method
Plasma concentrations of TA-8995, midazolam and digoxin	Over 16 days

Trial Locations

Locations (1)

Covance; 🇬🇧 Leeds, United Kingdom