jRCT2080224969已完成1 期
A randomized, single-center, double-blind, placebo-controlled, phase 1 study to investigate the safety, tolerability, and pharmacokinetics of single and repeated oral doses of SCO-267 in healthy adults and subjects with impaired glucose tolerance
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- safety
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Randomized, single-center, double-blind, placebo-controlled study
- 主要目的
- Other
入排标准
- 年龄范围
- 20age old over 至 85age old under（—）
- 性别
- Male
入选标准
- •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)
排除标准
- •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.
结局指标
主要结局
safety
时间窗: Repeat-dose part
Adverse events, vital signs, body weight, safety assessment electrocardiogram, laboratory tests
pharmacokinetics
时间窗: Repeat-dose part
Plasma concentrations and urinary excretions of SCO-267
次要结局
- plasma insulin concentration(Single-dose part)
- 75 g oral glucose tolerance test (75 g OGTT)(Single-dose part)
- plasma glucagon concentration(Single-dose part)
- plasma GLP-1 concentration(Single-dose part)
- plasma GIP concentration(Single-dose part)
- plasma PYY concentration(Single-dose part)
- Plasma GLP-1 concentration(Repeat-dose part)
- Plasma GIP concentration(Repeat-dose part)
- Plasma PYY concentration(Repeat-dose part)
- Plasma glucagon concentration(Repeat-dose part)
- Plasma insulin concentration(Repeat-dose part)
研究者
研究点 (1)
Loading locations...
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