Healthy adult Japanese male
Conditions
Interventions
investigational material(s)
Generic name etc : TAK-272, Itraconazole, Digoxin, Midazolam
INN of investigational material :
Therapeutic category code : --- Other
Dosage and Administration for Investig
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
Male
Inclusion 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
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. 11.The participant with hypersensitivity to itraconazole, digoxin, digitalis preparation, or midazolam. 12.The participant with allergy to cherries. 13.The participant with a positive to urine test for drug abuse at the screening. 14.The participant with a history of drug abuse (defined as illegal drug use) or alcohol addiction within 1 year prior to the screening visit, and those who are not willing to give up alcohol or drugs during the study period. 15.The participant who needs to use prohibited concomitant drugs,vitamins, or foods listed in the table of prohibited concomitant drugs and foods, and the participant who has used any of them during the period prohibiting the concomitant use. 16.Male participants who plans to donate sperm during the study period or up to 12 weeks after the end of the study. 17.The participant who currently has cardiovascular, central nervous, hepatic, or hematopoietic disease, renal insufficiency, metabolic or endocrinological disorder, serious allergy, asthma, hypoxemia, hypertension, convulsions, or allergic rash. 18.The participant with a disease history, examination findings, or clinical test findings related to safety that reasonably suggest a disease for which TAK 272 or related renin inhibitors in the same class, itraconazole, digoxin, or midazolam is contraindicated or a disease that may affect the study conduct (which includes, for example, peptic ulcer disease, convulsive disorder, and arrhythmia). 19.The participant who curently has or recently had (within the past 6 months) gastrointestinal disease that may affect drug absorption (malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [at least once a week] heartburn, surgical intervension [e.g., cholecystectomy]). 20.The participant with a past history of cancer. 21.The participant who is postive for any of the following at screening: hepatitis B virus surface antigen (HBs), antibody against hepatitis C virus (HCV), human immunodeficiency virus (HIV) antigen, anti-HIV antibody, or serological tests for syphilis. 22.The participant with difficulty having blood collected from a peripheral vein. 23.The participant who donated 200 mL or more whole blood within the 4 weeks (28 days) or 400 mL or more whole blood within the 12 weeks (84 days) before starting the study drug a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics and safety Timeframe; Cohort 1: 19 days, Cohort 2: 15 days Pharmacokinetics: (Cohort 1) - Maximum observed plasma concentrations (Cmax) of TAK-272F and TAK-272 metabolite - Area under the plasma concentration-time curve (AUC) of TAK-272F and TAK-272 metabolite - Urinary excretion rates of TAK-272F and TAK-272 metabolite (Cohort 2) - Maximum observed plasma concentrations (Cmax) of digoxin - Area under the plasma concentration-time curve (AUC) of digoxin - Urinary excretion rates of digoxin - Maximum observed plasma concentrations (Cmax) of midazolam and its metabolite - Area under the plasma concentration-time curve (AUC) of midazolam and its metabolite Safety: (Cohort 1 and Cohort 2) Number of participants who experience at least 1 treatment-emergent adverse event | — |
Outcome results
None listed