Healthy Volunteer
Conditions
Interventions
investigational material(s)
Generic name etc : TAK-438 (Single dose) and low-dose aspirin, loxoprofen sodium, diclofenac sodium or meloxicam (Multiple doses)
INN of investigational material :
Therape
Once per day, low-dose aspirin 100mg, loxoprofen sodium 60mg, diclofenac sodium 25mg or meloxicam 10mg
Oral (Single dose), and 3 times or once per day, Oral (Multiple doses)
control material(s)
Generic name etc : low-dose aspirin, loxoprofen sodium, diclofenac sodium or meloxicam (Single dose) and TAK
3 times or once per day, Oral (Single dose), and Once per day, TAK-438 40mg Oral (Multiple doses)
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.The subject is a healthy adult Japanese male volunteer. 2.The subject is aged 20 to 45 years, inclusive, at time of informed consent. 3.The subject is capable of understanding and complying with protocol requirements. 4.The subject signs a written informed consent form prior to the initiation of any study procedures. 5.The subject weighs at least 50 kg and has a body mass index (BMI) between 18.5 and 24.9 kg/m^2 inclusive at screening. 6.The subject with a maximum platelet-aggregating activity of at least 70% in the results on platelet aggregation test (platelet-aggregation inducing agent: collagen, arachidonic acid) at screening. (cohort 5 only) 7.The subject has negative results for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus (HIV) antigen/antibody and serological reactions for syphilis. 8.The subject whom the investigator or subinvestigator confirmed to be eligible to participate in the study based on the results of the screening tests, and medical examination, physical findings, vital signs, electrocardiogram (ECG), laboratory tests etc.
Exclusion criteria
Exclusion criteria: 1.The subject presently has or has a history of hepatic disorder, renal disorder, cardiovascular system disease, hematological disease, endocrine disease, metabolic disease, pulmonary disease, gastrointestinal disease, neurological disease, urological disease, immunological disease or psychiatric disease that makes him not eligible to participate in this study. 2.The subject presently has or has a history of hypersensitivity or allergy towards drugs or food. 3.The subject has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 5 years prior to the start of study drug administration. 4.The subject has poor peripheral venous access. 5.The subject has undergone whole blood collection of at least 200 mL within 4 weeks (28 days) or at least 400 mL within 12 weeks (84 days) prior to the start of study drug administration. 6.The subject has undergone whole blood collection of at least 800 mL in total within 52 weeks (364 days) prior to the start of study drug administration. 7.The subject has undergone blood component collection within 2 weeks (14 days) prior to the start of study drug administration. 8.The subject has used a prescription drug (including nonprescription medications) within 4 weeks (28 days) prior to the start of study drug administration. 9.The subject has used vitamins, Chinese herbal remedies, or supplement (including St. John's Wort, ginseng, kava kava, ginkgo biloba, melatonin) within 4 weeks (28 days) prior to the start of study drug administration. 10.The subject has ingested any foods or beverages containing grapefruit (juice or flesh of fruit), caffeine, alcohol within 72 hours prior to the start of study drug administration. 11.The subject has received another study drug within 16 weeks (112 days) prior to the start of study drug administration. 12.The subject participated in a previous clinical study of TAK-438. 13.The subject who, in the opinion of the investigator or subinvestigator, is unlikely to comply with the protocol or is unsuitable for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentrations; TAK-438F and its metabolites (M-I, M-II, M-III and M-IV-Sul), Unchanged aspirin and its metabolite (salicylic acid), Unchanged loxoprofen and its active metabolite (trans-OH metabolite), Unchanged diclofenac, Unchanged meloxicam Timeframe; Cohort 1 to 4, 6 and 7; 15days, Cohort 5; 26days, Cohort 8; 17days | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: Adverse events (AEs), vital signs, weight, electrocardiograph (ECG) findings and laboratory test results. Timeframe; Cohort 1 to 4, 6 and 7; 15days, Cohort 5; 26days, Cohort 8; 17days | — |
Outcome results
None listed