JPRN-jRCT2080222758
Unknown
Phase 1
An Open-label, 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 and Midazolam in the Healthy Adult Subjects
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- TAKEDA PHARMACEUTICAL COMPANY LTD.
- Enrollment
- 34
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- •2\.The participant who can sign and date the informed consent form before the initiation of the study procedure.
- •3\.Healthy Japanese adult male volunteer.
- •4\.The participant whois 20 to 35 years of age at the time of informed consent
- •5\.The participant who weighs 50 kg or more with a body mass index (BMI) of 18\.5 to less than 25\.0 kg/m2 at the screening test.
- •6\.A male participant who is nonsterilized and sexually active with a female partner of childbearing potential and who agrees to use adequate contraception from the signing of informed consent to 12 weeks after the last dose of erythromycin.
Exclusion Criteria
- •1\.The participant who was administered any investigational product within 16 weeks (112 days) prior to the initial drug administration.
- •2\.The participant who has received TAK\-272 in previous.
- •3\.Employees of the study site, their family members, those who are in a dependency relationsip with employees of the study site involved in the conduct of the study (e.g., spouse, parents, children, brothers and sisters), or those who might be coerced to consent to participate in the study.
- •4\.The participant 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\.The participant who has a history of serious hepatic disease.
- •6\.The participant who has atrioventricular block or sinoatrial block.
- •7\.The participant with digitalis intoxication.
- •8\.The participant with acute narrow\-angle glaucoma.
- •9\.The participant with myasthenia gravis.
- •10\.The participant with hypersensitivity to TAK\-272 or any other renin inhibitors.
Outcomes
Primary Outcomes
Not specified
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