A Double-Blind, Randomized, Placebo-Controlled Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of CT-996 in Overweight/Obese Participants and in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
This study is designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of CT-996 in overweight/obese participants and participants with Type 2 Diabetes Mellitus (T2DM).
详细描述
This is a multi-center, randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of CT-996 when administered as single ascending doses (SAD) and multiple-ascending doses (MAD) in overweight/obese participants and as multiple doses (MD) in patients with T2DM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Participants 18-65 years old, inclusive
- •BMI of 25 - 40, inclusive
- •Stable body weight for two months
- •Additional Inclusion Criterion for Part 3 (MD T2DM cohorts) only:
- •Participants in Part 3 should have a documented diagnosis of Type 2 Diabetes Mellitus (T2DM)
- •Participants in Part 3 should have glycated hemoglobin (HbA1c) between 7.0% and 10.0%
排除标准
- •History of significant medical conditions and malignancy
- •Uncontrollable hypertension
- •History of alcoholism or drug addiction within 1 year prior to Screening
- •Current or recent participation in an investigational clinical trial
研究组 & 干预措施
Part 1: CT-996 SAD Cohort 1
干预措施: CT-996 (Drug)
Part 1: CT-996 SAD Cohort 2
干预措施: CT-996 (Drug)
Part 1: CT-996 SAD Cohort 3, Then SAD Cohort 5
During SAD Cohort 3, participants will be dosed under fasted conditions. During SAD Cohort 5, the same participants will receive the same dose under high-fat fed conditions.
干预措施: CT-996 (Drug)
Part 1: CT-996 SAD Cohort 4
干预措施: CT-996 (Drug)
Part 1: CT-996 SAD Cohort 6
干预措施: CT-996 (Drug)
Part 1: Placebo SAD Cohort
干预措施: Placebo (Drug)
Part 2: CT-996 MAD Cohort 1
干预措施: CT-996 (Drug)
Part 2: CT-996 MAD Cohort 2
干预措施: CT-996 (Drug)
Part 2: CT-996 MAD Cohort 3
干预措施: CT-996 (Drug)
Part 2: Placebo MAD Cohort
干预措施: Placebo (Drug)
Part 3: CT-996 MD T2DM Cohort 1
干预措施: CT-996 (Drug)
Part 3: CT-996 MD T2DM Cohort 2
干预措施: CT-996 (Drug)
Part 3: Placebo MD T2DM Cohort
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: From first study drug administration until last safety follow-up (up to 31 days [Part 1] or 58 days [Parts 2 and 3])
次要结局
- Maximum Observed Plasma Concentration (Cmax) of CT-996(At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3))
- Time to Maximum Observed Plasma Concentration (Tmax) of CT-996(At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3))
- Area Under the Concentration-Time Curve (AUC) from Time 0 to the Time of Last Measurable Concentration (AUC0-t) of CT-996(At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3))
- AUC from Time 0 Extrapolated to Infinity (AUC0-inf) of CT-996(At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3))
- Apparent Terminal Elimination Half-Life (t1/2) of CT-996(At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3))
- Part 1 Cohorts: Clearance (CL) of CT-996(At prespecified timepoints from Day 1 to Day 5)
- Part 1 Cohorts: Volume of Distribution (V) of CT-996(At prespecified timepoints from Day 1 to Day 5)
- Parts 2 and 3 Cohorts: Volume of Distribution Divided by the Bioavailable Fraction (Vz/F) of CT-996(At prespecified timepoints from Day 1 to Day 33)
- Part 2 Cohorts: Minimum Observed Plasma Concentration (Cmin) of CT-996(At prespecified timepoints from Day 1 to Day 33)
- Parts 2 and 3 Cohorts: Clearance Divided by the Bioavailable Fraction (CL/F) of CT-996(At prespecified timepoints from Day 1 to Day 33)
- Part 1 SAD Cohorts 3 and 5: Food Effect of a High-Fat Meal on Cmax of CT-996(At prespecified timepoints for up to 14 days)
- Part 1 SAD Cohorts 3 and 5: Food Effect of a High-Fat Meal on AUC of CT-996(At prespecified timepoints for up to 14 days)