A Preliminary Drug Drug Interaction Study With TA-8995

A Phase I, Open Label Study to Assess the Effects of TA-8995 on the Pharmacokinetics of Midazolam and Digoxin in Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02124954

Enrollment

Registered

2014-04-28

Start date

2014-05-31

Completion date

2014-07-31

Last updated

2016-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetic Interactions

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).

Interventions

DRUGTA-8995

DRUGMidazolam

DRUGDigoxin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male subjects

Exclusion criteria

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

Design outcomes

Primary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026