A Phase 2a, Double-blind, Randomized, Placebo-controlled, Study to Assess Food Effect, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Oral Doses of MKP10241 in Healthy and Obese Adult Participants, With and Without Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Part 1 - Food effect of single dose of MKP10241 on Maximum concentration of drug (Cmax)
研究概览
简要总结
The goal of this intervention study is to evaluate the safety, tolerability and pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of MKP10241 in obese participants with and without T2DM in 3 parts. The main parameters it aims to answers are :
- Does food effects the pharmacokinetic parameters following a single dose of MKP10241 in healthy participants?
- Will multiple ascending doses of MKP10241 in obese participants with or without T2DM characterize changes in the plasma pharmacokinetic profile and pharmacodynamic effects?
- What treatment emergent adverse events or discontinuation is experienced following single and multiple ascending doses of MKP10241 in healthy and obese participants with or without T2DM?
This study will be compared against a placebo which is matched in appearance to MKP10241 at dosage strengths.
Participants will:
- Part 1: Take MKP10241 400 mg or Placebo on Day 1 and Day 8. Part 2: Take MKP10241 200 mg, 300 mg and 400 mg or Placebo daily from Day 1 to Day 28 Part 3: Take MKP10241 300 mg and 400 mg or Placebo daily from Day 1 to Day 28
- Visit the clinical research unit for dose administration, admission or follow up.
- Will be monitored by the Safety Monitoring Committee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Part 1 of the study is Open Label but Part 2 and 3 is a double blind ,in which participants/care providers/investigators/outcomes assessors, etc are blinded to study intervention
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Part 1- MKP10241 400 mg
Participants will receive MKP10241 400 mg on Day 1 and Day 8.
干预措施: MKP10241 (Drug)
Part 1 - Placebo
Participants will receive placebo 400 mg on Day 1 and Day 8.
干预措施: Placebo (Drug)
Part 2 - MKP10241 200 mg, 300 mg and 400 mg
Participants will receive MKP10241 200 mg, 300 mg and 400 mg daily from Day 1 to Day 28
干预措施: MKP10241 (Drug)
Part 2 - Placebo
Participants will receive placebo daily from Day 1 to Day 28
干预措施: Placebo (Drug)
Part 3 - MKP10241 300 mg and 400 mg
Participants will receive MKP10241 300 mg and 400 mg daily from Day 1 to Day 28
干预措施: MKP10241 (Drug)
Part 3 - Placebo
Participants will receive placebo daily from Day 1 to Day 28
干预措施: Placebo (Drug)
结局指标
主要结局
Part 1 - Food effect of single dose of MKP10241 on Maximum concentration of drug (Cmax)
时间窗: 18 days
Maximum concentration (Cmax) following a single 400 mg dose of MKP10241 under fasting and fed condition
Part 1 - Food effect of single dose of MKP10241 on Apparent total clearance of drug (CL/F)
时间窗: 18 days
Total Clearance of the drug following a single 400 mg dose of MKP10241 under fasting and fed conditions
Part 1 - Food effect of single dose of MKP10241 on Time to maximum concentration (Tmax)
时间窗: 18 days
Time to maximum concentration (Tmax) following a single 400 mg dose of MKP10241 under fasting and fed condition
Part 1 - Food effect of single dose of MKP10241 on elimination half life (t1/2 )
时间窗: 18 days
Elimination Half life (t1/2) following a single 400 mg dose of MKP10241 under fasting and fed conditions
Part 1 - Food effect of single dose of MKP10241 on Apparent Volume of distribution of drug (V/F)
时间窗: 18 days
Apparent Volume of distribution of drug(V/F) following a single 400 mg dose of MKP10241 under fasting and conditions
Part 1 - Food effect of single dose of MKP10241 on lag time (Tlag)
时间窗: 18 days
Delay between the time of dosing and the time of appearance of the drug concentration in sampling (Tlag) for single 400 mg dose of MKP10241 under fasting and fed conditions
Part 2 - To evaluate the incidence of treatment emergent adverse events and participant tolerance of MKP10241 following multiple doses in obese participants
时间窗: 35 days
It will be measured based on the Treatment emergent adverse events which includes significant changes in examination, blood and urine analysis, vital signs and ECG etc. Treatment discontinuation for any reason considered as intolerant.
Part 1 - Food effect of single dose of MKP10241 on Area under the curve from time 0 to 24hrs - AUC (0-24h)
时间窗: 18 days
Area under the plasma concentration time curve from time 0 to 24hrs - AUC(0-24h) following a single 400 mgMKP10241 under fasting and fed conditions
Part 1 - Food effect of single dose of MKP10241 on AUC(0-last)
时间窗: 18 days
Area under the curve from time 0 to the last value above the limit of quantification AUC(0-last) following a single dose of MKP10241 under fasting and fed conditions
Part 1 - Food effect of single dose of MKP10241 on AUC(0-inf)
时间窗: 18 days
Area under the curve from time 0 extrapolated to infinity AUC(0-inf) following a single 400 mg dose of MKP10241 fasting and fed conditions
Part 3 - To evaluate the incidence of treatment emergent adverse events and participant tolerance of MKP10241 following multiple doses in obese participants with T2DM.
时间窗: 35 days
It will be measured based on the Treatment emergent adverse events which includes significant changes in examination, blood and urine analysis, vital signs and ECG etc. Treatment discontinuation for any reason considered as intolerant.
次要结局
- Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM.(At Baseline,Day 1, 7, 14, 21 and Day 28)
- Part 1 - To evaluate the incidence of treatment emergent adverse events and of MKP10241 following a single dose administered orally under fasting and fed conditions.(18 days)
- Part 2 - Pharmacokinetics and Pharmacodynamics of MKP10241 following multiple doses in obese adult participants(Day 1, 2, 28 and 29)
- Part 2 - Pharmacokinetics and Pharmacodynamics of MKP10241 following multiple doses in obese adult participants with T2DM.(At Baseline,Day 1, 7, 14, 21 and Day 28)
- Part 2 - Pharmacokinetics and Pharmacodynamics of MKP10241 following multiple doses in obese adult participants.(At baseline and Day 28)
- Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM(35 days)