A Study to Assess 11 Beta-hydroxysteroid Dehydrogenase Type 1 Inhibition in Adipose Tissue by SPI-62
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (Cmax)
研究概览
简要总结
This will be an exploratory, open-label study of 11β-hydroxysteroid dehydrogenase type 1 (HSD-1) inhibition by SPI-62 in obese subjects with type 2 diabetes mellitus (T2DM)
详细描述
The main objective of the study is to characterize the relationship between SPI-62 plasma concentration and adipose tissue inhibition of HSD-1 in obese subjects with T2DM.Additional objectives of the study are to characterize the relationship between adipose SPI-62 concentration and HSD-1 inhibition, to characterize the relationship between SPI-62 plasma concentration and liver inhibition of HSD-1, and to monitor the safety and tolerability of SPI-62, in obese subjects with T2DM. This will be a Phase I, open-label study in male and non-menstruating female subjects. Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the first dose administration. Subjects will receive SPI-62 daily for up to 14 days. Subjects will also receive cortisone-d8, a mass-labeled HSD-1 substrate, by infusion during one or two confined study visits during the period of SPI-62 administration. Subjects may also receive cortisone-d8 during one to four additional confined study visits after cessation of SPI-62. Subjects will receive a follow-up call approximately 30 days after the last dose of study drug (SPI-62 or cortisone-d8). Results of population pharmacokinetic-pharmacodynamic modeling of data from this trial combined with those of prior trials will be reported separately from the Clinical Study Report.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or non-menstruating female
- •18 to 65 years of age
- •BMI 30.0 to 45.0 kg/m2
- •Diagnosis of T2DM for at least 3 months prior to the first dose of study drug.
排除标准
- •Uncontrolled T2DM with glycated hemoglobin ≥9.5%.
- •Any other current or prior medical condition expected to interfere with the conduct of the trial or the evaluation of its results.
- •Any clinically significant abnormal laboratory value which cannot be explained by a known and permitted clinical condition.
- •Positive urine drug screen (except tetrahydrocannabinol) or positive alcohol breath test result.
- •Participation in a clinical trial involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives, whichever is longer, or 90 days for a biological, prior to the first dose of study drug.
- •Use of, or intent to use, any medications/products (prescription or over-the-counter) or herbal supplements within 4 weeks prior to the first dose of study drug, except those specifically allowed in the protocol.
研究组 & 干预措施
Single Arm
Each subject will receive between 1 to 15 mg SPI-62 QD PO for up to 14 days.
Each subject will receive up to 12 mcg cortisone-d8 SC during each of one or more study visits.
干预措施: SPI-62 (Drug)
Single Arm
Each subject will receive between 1 to 15 mg SPI-62 QD PO for up to 14 days.
Each subject will receive up to 12 mcg cortisone-d8 SC during each of one or more study visits.
干预措施: Cortisone-d8 (Drug)
结局指标
主要结局
Pharmacokinetics (Cmax)
时间窗: Days 1 through 14
Pharmacokinetics of SPI-62 and its major metabolite AS2570469 by assessment of Observed Maximum Plasma Concentration (Cmax)
次要结局
- Pharmacokinetics (tmax)(Days 1 through 14)
- Pharmacokinetics (AUC0-t)(Days 1 through 14)
- Cortisone-d8 concentrations(Days 1 through 14)
- Urinary HSD-1 Ratio(Days -1 to 15)