Healthy male adult, subjects with impaired glucose tolerance
Conditions
Interventions
investigational material(s)
Generic name etc : SCO-267
INN of investigational material : -
Therapeutic category code : 396 Antidiabetic agents
Dosage and Administration for Investigational material :
Sponsors
SCOHIA PHARMA, Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: -Healthy adult Japanese males or subjects with impaired glucose tolerance (both parents and grandparents of the subject are Japanese) or healthy adult Caucasian males (both parents and grandparents of the subject are Caucasian) -Subjects aged 20 to 45 years (excluding cohorts 8, 9, and 12) at the time of informed consent, subjects aged 20 to 70 years at the time of informed consent (cohorts 8 and 9 only), or subjects aged 65 to 85 years at the time of informed consent (cohort 12 only). -Subjects with body weight >= 50 kg at screening and BMI between 18.5 kg/m2 and 25.0 kg/m2 (excluding cohort 7b, 8, 9 and 12) or with body weight >= 50 kg at screening and BMI between 18.5 kg/m2 and 30.0 kg/m2 (cohort 7b, 8, 9 and 12 only) -Subjects with a screening HbA1c of 10% or less (cohorts 8 and 9 only) -Subjects with a blood glucose level of 230 mg/dL 2 hours after the screening 75g oral glucose tolerance test (75 g OGTT) (cohorts 8 and 9 only)
Exclusion criteria
Exclusion criteria: -Subjects who received investigational product within 16 weeks (112 days) prior to the initiation of investigational product treatment -Subjects with a C-peptide of 0.5 ng/mL or less at screening (cohorts 8 and 9 only) -Subjects with neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urinary or endocrine disorders or other abnormalities with poor control and clinically significant problems, who may affect the participation in the clinical trial or the results of the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety pharmacokinetics [Single-dose part] Safety: Adverse events, vital signs, body weight, safety assessment ECG, continuous digital 12-lead Holter ECG (Japanese healthy adult males only), laboratory tests Pharmacokinetics: Plasma concentrations and urinary excretions of SCO-267 [Repeat-dose part] Primary endpoint Safety: Adverse events, vital signs, body weight, safety assessment electrocardiogram, laboratory tests Pharmacokinetics: Plasma concentrations and urinary excretions of SCO-267 | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacodynamics [Single-dose part] Pharmacodynamic effects (only in subjects with impaired glucose tolerance):75 g oral glucose tolerance test (75 g OGTT), plasma insulin concentration, plasma glucagon concentration, plasma GLP-1 concentration, plasma GIP concentration, and plasma PYY concentration [Repeat-dose part] Pharmacodynamic effects: Plasma GLP-1 concentration, Plasma GIP concentration, Plasma PYY concentration, Plasma glucagon concentration, Plasma insulin concentration | — |
Countries
Japan
Outcome results
None listed