Japanese Healthy Male Participants
Conditions
Interventions
investigational material(s)
Generic name etc : TAK-906 50 mg, 100 mg or 10 mg
INN of investigational material : -
Therapeutic category code : 239 Other agents affecting digestive organs
Dosage and Adm
TAK-906 capsules, orally, once daily on Day 1 Multiple Dose Period
TAK-906 capsules, orally, twice daily from Day 3 to 7
control material(s)
Generic name etc : TAK-906 Placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Admin
Placebo capsules, orally, once daily on Day 1 Multiple Dose Period
Placebo capsules, orally, twice daily from Day 3 to 7
Sponsors
Takeda Pharmaceutical Company Limited
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.In the opinion of the investigator or sub-investigator, the participant is capable of understanding and complying with protocol requirements. 2.The participant signs and dates a written, informed consent form prior to the initiation of any study procedures. 3.The participant is a Japanese healthy adult male, aged 20 to 60 years, inclusive, at the time of informed consent. 4.The participant weighs at least 50 kg and has a body mass index (BMI) from 18.5 to 25 kg/m2, inclusive at Screening. 5.A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from the signing of informed consent to 12 weeks (84 days) after the last dose of study drug. The female partner of a male participant should also be advised to use adequate contraception.
Exclusion criteria
Exclusion criteria: 1.The participant has received any investigational compound within 16 weeks (112 days) prior to the first dose of study drug. 2.The participant has received TAK-906 in a previous clinical study or as a therapeutic agent. 3.The participant is an immediate family member of or an investigational site employee, or is in a dependent relationship with an investigational site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress. 4.The participant has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality, which may impact the ability of the participant to participate in the study or potentially confound its results. 5.The participant has a history of any psychiatric disease that would interfere with the evaluation of study drug activity (prolactin concentration) or safety. 6.The participant has a history of seizure or tardive dyskinesia. 7.The participant has a history of hyperprolactinemia, pituitary adenoma, and/or hypothyroidism. 8.The participant has a family history of prolonged QT. 9.The participant has undergone previous gastric bypass surgery or currently nad a gastric band fitted. 10.The participant has dysphagia and/or inability to swallow study medication whole. 11.The participant has a known hypersensitivity to any component of the TAK-906 formulation or related compounds. 12.The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 2 years prior to the Screening visit, or is unwilling to agree to abstain from alcohol and drugs throughout the study, or has a positive urine test result for drugs of abuse or a positive alcohol screen (urine alcohol test/breath test) result for alcohol at Screening. 13.The participant has taken any excluded medication, supplements, or dietary products during the time periods listed in the Excluded Medications, Supplements, and Dietary Products table. 14.If male, the participant intends to donate sperm during the course of this study or for at least 12 weeks (84 days) after the last dose of study drug. 15.The participant has current or recent (within 24 weeks [168 days]) gastrointestinal disease that would be expected to influence the absorption of drugs (ie, a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once per week] occurrence of heartburn, or any surgical intervention). 16.The participant has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1. 17.The participant has a positive test result for hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiencyvirus (HIV) antibody/antigen, or serological reactions for syphilis at Screening. 18.The participant has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 4 weeks (28 days) prior to the first dose of study drug. Cotinine test is positive at Screening. 19.The participant has poor peripheral venous access. 20.The participant 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. 21.The participant has undergone whole blood collection of at least 800 mL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE) Timeframe; Baseline up to Day 14 safety Number of Participants who Experience at Least One TEAE Related to Vital Signs Timeframe; Baseline up to Day 14 safety Number of Participants who Experience at Least One TEAE Related to Clinical Laboratory Tests Timeframe; Baseline up to Day 14 safety Number of Participants who Experience at Least One TEAE Related to 12-lead electrocardiogram (ECG) Timeframe; Baseline up to Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics AUC(inf): Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-906 and its Metabolite M23 on Day 1 of Single Dose Period Timeframe; Day 1: Pre-dose and at multiple time points (up to 24 hours) post-dose of Single Dose Period pharmacokinetics Cmax: Maximum Observed Plasma Concentration for TAK-906 and its Metabolite M23 on Day 1 of Single Dose Period Timeframe; Day 1: Pre-dose and at multiple time points (up to 24 hours) post-dose of Single Dose Period pharmacokinetics Ae(t): Amount of Drug Excreted in Urine from Time 0 to time t for TAK-906 and its Metabolite M23 on Day 1 of Single Dose Period Timeframe; Day 1: Pre-dose and at multiple time points (up to 24 hours) post-dose of Single Dose Period pharmacokinetics AUC(t,ss): Area Under the Plasma Concentration-time Curve from Time 0 during Dosing Interval at Steady State for TAK-906 and its Metabolite M23 on Day 7 of Multiple Dose Period Timeframe; Day 7: Pre-dose and at multiple time points (up to 24 hours) post-dose of Multiple Dose Period pharmacokinetics Cmax,ss: Maximum Observed Plasma Concentration During Dosing Interval at Steady State for TAK-906 and its Metabolite M23 on Day 7 of Multiple Dose Period Timeframe; Day 7: Pre-dose and at multiple time points (up to 24 hours) post-dose of Multiple Dose Period pharmacokinetics Ae(t): Amount of Drug Excreted in Urine during Dosing Interval for TAK-906 and its Metabolite M23 on Day 7 of Multiple Dose Period Timeframe; Pre-dose and at multiple time points (up to 24 hours) post-dose of Multiple Dose Period pharmacokinetics AUCt: Area Under the Serum Concentration-time Curve from Time 0 for Serum Prolactin on Day 1 of Single Dose Period Timeframe; Day 1: Pre-dose and at multiple time points (up to 24 hours) post-dose of Single Dose Period pharmacokinetics Cmax: Maximum Observed Serum Concentration for Serum Prolactin on Day 1 of Single Dose Period Timeframe; Day 1: Pre-dose and at multiple time points (up to 24 hours) post-dose | — |
Countries
Japan
Outcome results
None listed