Japanese healthy adult males
Conditions
Interventions
investigational material(s)
Generic name etc : SYR-472
INN of investigational material :
Therapeutic category code : 396 Antidiabetic agents
Dosage and Administration for Investigational material : S
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Participants who understand the outline of the clinical study and are capable of complying with their responsibilities as participants, as judged by the investigator or subinvestigator. 2.Participants who can sign and date the informed consent form before the initiation of the study procedure 3.Healthy Japanese adult males. 4.Participants who are 20 to 35 years of age at the time of informed consent. 5.Participants who weigh 50.0 kg or more with a body mass index (BMI) of 18.5 to less than 25.0 kg/m2 in the screening period.
Exclusion criteria
Exclusion criteria: 1.Participants who were administered any investigational product within 16 weeks (112 days) before the start of the study drug administration in stage 1. 2.Participants who have received SYR-472 in the past. 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 (e.g., spouse, parents, children, brothers and sisters), and those who might be coerced to consent to participate in the study. 4.Participants who have poorly controlled, clinically significant abnormalities of the nervous system, cardiovascular system, lung, liver, kidneys, metabolism, gastrointestinal system, urinary system, or endocrinological system, which possibly may affect study participation or study results. 5.Participants who have a positive urine drug test in the screening period. 6.Participants who need to use drugs or foods listed in the table of prohibited concomitant drugs and foods. 7.Participants who have a history of hypersensitivity or allergy to drugs (including SYR-472 and its ingredients). 8.Participants who currently have 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 intervention [e.g., cholecystectomy]). 9.Participants with a past history of cancer. 10.Participants who are postive for any of the following during the screening period: hepatitis B virus surface antigen (HBsAg), antibody against hepatitis C virus (HCV), human immunodeficiency virus (HIV) antigen, anti-HIV antibody, or serological test for syphilis. 11.Participants with difficulty having blood collected from a peripheral vein. 12.Participants who donated 200 mL or more of whole blood within the 4 weeks (28 days) or 400 mL or more of whole blood within the 12 weeks (84 days) before starting the study drug administration in stage 1. 13.Participants who donated a total of 800 mL or more of whole blood within the 52 weeks (364 days) before starting the study drug administration in stage 1. 14.Participants who donated blood components within the 2 weeks (14 days) before starting the study drug administration in stage 1. 15.Participants who show clinically significant abnormalities in electrocardiogram (ECG) during the screening period or on Day 1 (before the study drug administration). 16.Participants who have laboratory test abnormalities suggestive of a clinically significant primary disease or who have abnormal values in any of the following parameters: ALT or AST exceeding 1.5 times the upper limit of the normal range. 17.Participants who are unlikely to comply with the study protocol or are ineligible for the study for any other reason, as judged by the investigator or subinvestigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: AUC and Cmax of unchanged SYR-472 (hereinafter referred to as SYR-472Z) Timeframe; 9 days AUC is measure of area under the curve over the dosing interval (tau) (AUC(0-tau)), where tau is the length of the dosing interval) . Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: AUC, Tmax, MRT, and Lz of SYR-472Z Safety: Adverse events, 12-lead ECG, laboratory tests, vital signs, body weight Timeframe; 9 days AUC is measure of area under the curve over the dosing interval (tau) (AUC(0-tau)), where tau is the length of the dosing interval) . Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Mean Residence Time is the mean of the time that a drug spend in the body. Terminal elimination rate constant (Lz) is the rate at which drugs are eliminated from the body. The frequencies of all adverse events observed during the observation period will be tabulated by type and seriousness, and causal relationship to SYR-472. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, reported from the first dose to the last dose of SYR-472. TEAEs are defined as events occurring after the start of administration of an investigational product or events that occur due to the worsening of the present illnes | — |
Outcome results
None listed