A Preliminary Drug Drug Interaction Study With TA-8995

Xention

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetic Interactions

Treatments: Drug: Midazolam; Drug: Digoxin; Drug: TA-8995

Study type: Interventional

Funder types: Industry

Identifiers

NCT02124954

TA-8995-05

Details and patient eligibility

About

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).

Enrollment: 18 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Healthy male subjects

Exclusion Criteria

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

Trial design

18 participants in 2 patient groups

Digoxin with/without TA-8995

Experimental group

Description:

Digoxin with/without TA-8995

Treatment:

Drug: Digoxin

Drug: TA-8995

Midazolam with/without TA-8995

Experimental group

Description:

Midazolam with/without TA-8995

Treatment:

Drug: Midazolam

Drug: TA-8995