Healthy adult male subject
Conditions
Interventions
investigational material(s)
Generic name etc : TAK-114
INN of investigational material :
Therapeutic category code : 239 Other agents affecting digestive organs
Dosage and Administration for Investig
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Healthy Japanese Subjects: - All subjects must be willing to provide written informed consent and in the investigator's opinion able to comply with the study protocol. - Male subjects aged 20 to 45 years, inclusive. - All subjects should weigh at least 45 kg (99 lb) and have a body mass index between 18.5 and 25.0 kg/m2. Healthy Caucasian Subjects: - All subjects must be willing to provide written informed consent and in the investigator's opinion able to comply with the study protocol. - Male subjects aged 20 to 45 years, inclusive; are of Caucasian descent (born to Caucasian parents and grandparents and has lived outside original country for less than 5 years) and maintains their original diet and lifestyle. - All subjects should weigh at least 45 kg (99 lb) and have a body mass index between 18.5 and 30.0 kg/m2.
Exclusion criteria
Exclusion criteria: - Subjects have a known hypersensitivity to any component of the formulation of TAK-114 or any herb medicine or supplement related to Indigo naturalis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of treatment emergent adverse events (TEAEs) Primary timeframe Single-dose Ascending Part: For 3 days during the treatment period Multiple -dose Ascending Part: For 12 days during the treatment period and 5 days during the follow-up period The frequencies of all adverse events observed during the observation period will be tabulated by type and seriousness, and causal relationship to TAK-114. 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 TAK-114. 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 illness. | — |
Secondary
| Measure | Time frame |
|---|---|
| -Pharmacokinetics: Plasma concentrations of unchanged TAK-114 Urinary excretion of TAK-114 (only for Cohorts 1A to 3A and Cohorts 1B to 3B) Secondary timeframe [Plasma concentrations] Single-dose Ascending Part: For 3 days during the treatment period Food Effect Part: For 3 days during the treatment period (excluding the 14-day washout interval between the two periods) Multiple-dose Ascending Part: For 12 days during the treatment period and 5 days during the follow-up period [Urinary excretion] Single-dose Ascending Part: For 3 days during the treatment period (1)Single-dose Ascending Part and Food Effect Part The pharmacokinetic parameters will be estimated from a model-independent analysis of the time course of changes in plasma concentration of TAK-114 until 48 hours after the administration of a single-dose. (2)Multiple-dose Ascending Part For the start day (Day 1) and end day (Day 10) of multiple-dose administration, the pharmacokinetic parameters of TAK-114 will be estimated from a model-independent analysis of the time course of changes in plasma concentration of TAK-114 during the specified period of each day - i.e., the time course on Day 1 is for the period from prior to the first dose until 12 hours after the first dose, and the time course on Day 10 is for the period from prior to the last dose (216 hours after the first dose) until 48 hours after the last dose (264 hours after the first dose). [Urinary excretion rate] For individual subjects, the cumulative urinary excretion rate (% of dose amount [equivalent to unchanged TAK-114]) until the end of the urine-collection period will be determined from the urinary concentration of TAK-114 and urine output during each urine-collection period. | — |
Outcome results
None listed