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Drug-Drug Interaction Study Between TAK-272 and Itraconazole, Digoxin or Midazolam | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Drug-Drug Interaction Study Between TAK-272 and Itraconazole, Digoxin or Midazolam

A Phase 1, Drug-Drug Interaction Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of TAK-272 and the Effect of TAK-272 on the Pharmacokinetics of Digoxin or Midazolam In the Healthy Adult Participants

NCT02370615•Takeda

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the effect of repeated-dose administration of itraconazole on the pharmacokinetics of TAK-272, as well as the effect of repeated-dose administration of TAK-272 on the pharmacokinetics of digoxin or midazolam in healthy Japanese adult males.

Detailed Description

In Cohort 1, the effect of repeated-dose administration of itraconazole on the pharmacokinetics of TAK-272 was evaluated by comparing between participants receiving TAK-272 alone and those receiving TAK-272 in combination with itraconazole. In Cohort 2, the effect of repeated-dose administration of TAK-272 on the pharmacokinetics of digoxin or midazolam was evaluated by comparing between participants receiving digoxin or midazolam alone and those receiving either of the drugs in combination with TAK-272.

Eligibility

Age

20 - 35 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. Is capable of understanding and complying with protocol requirements.
•2. Who can sign and date the informed consent form before the initiation of the study procedure.
•3. Healthy Japanese adult male volunteer.
•4. Is of 20 to 35 years of age at the time of informed consent
•5. Weighs 50 kilogram (kg) or more with a body mass index (BMI) of 18.5 to less than 25.0 kilogram per square meter (kg/m\^2) at the screening test.
•6. Male participant who was nonsterilized and sexually active with a female partner of childbearing potential had to agree to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after the completion of the study.

Exclusion Criteria

•1. Who was administered any investigational product within 16 weeks (112 days) prior to the initial drug administration.
•2. Who has received TAK-272 in previous.
•3. Employees of the study site, their family members, those who are in a dependency relationship with employees of the study site involved in the conduct of the study (example, spouse, parents, children, brothers and sisters), or those who might be coerced to consent to participate in the study.
•4. Who has poorly controlled, clinically significant abnormalities of the nervous system, cardiovascular system, lungs, liver, kidneys, metabolism, gastrointestinal system, urinary system, endocrinological system or other organs or systems, and which may possibly affect study participation or study results.
•5. Who has a history of serious hepatic disease.
•6. Who has atrioventricular block or sinoatrial block.
•7. Has digitalis intoxication.
•8. Has acute narrow-angle glaucoma.
•9. Has myasthenia gravis.
•10. Has hypersensitivity to TAK-272 or any other renin inhibitors.
+19 more criteria

Locations (1)

Osaka, Osaka, Japan

Key Dates

Start Date

February 1, 2015

Primary Completion Date

April 1, 2015

Completion Date

April 1, 2015

Last Updated

May 23, 2016

Enrollment

ACTUAL participants

Conditions

Japanese Healthy Adult Males

Interventions

TAK-272

DRUG

Digoxin

DRUG

Itraconazole

DRUG

Midazolam

DRUG