Food Effect, Efficacy and Safety of MKP10241 in Healthy and Obese Adult Participants, With and Without Diabetes
- Conditions
- Type 2 Diabetes Mellitus (T2DM)Food EffectSafety and TolerabilityObesity
- Interventions
- Drug: Placebo
- Registration Number
- NCT07098663
- Lead Sponsor
- Mankind Pharma Limited
- Brief Summary
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 :
1. Does food effects the pharmacokinetic parameters following a single dose of MKP10241 in healthy participants?
2. Will multiple ascending doses of MKP10241 in obese participants with or without T2DM characterize changes in the plasma pharmacokinetic profile and pharmacodynamic effects?
3. 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:
1. 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
2. Visit the clinical research unit for dose administration, admission or follow up.
3. Will be monitored by the Safety Monitoring Committee.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 68
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1- MKP10241 400 mg MKP10241 Participants will receive MKP10241 400 mg on Day 1 and Day 8. Part 3 - Placebo Placebo Participants will receive placebo daily from Day 1 to Day 28 Part 1 - Placebo Placebo Participants will receive placebo 400 mg on Day 1 and Day 8. Part 2 - Placebo Placebo Participants will receive placebo daily from Day 1 to Day 28 Part 3 - MKP10241 300 mg and 400 mg MKP10241 Participants will receive MKP10241 300 mg and 400 mg daily from Day 1 to Day 28 Part 2 - MKP10241 200 mg, 300 mg and 400 mg MKP10241 Participants will receive MKP10241 200 mg, 300 mg and 400 mg daily from Day 1 to Day 28
- Primary Outcome Measures
Name Time Method Part 1 - Food effect of single dose of MKP10241 on Maximum concentration of drug (Cmax) 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) 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) 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 ) 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) 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) 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 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) 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) 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) 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. 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.
- Secondary Outcome Measures
Name Time Method 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 Pharmacodynamic parameters - Triglyceride
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 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.
Part 2 - Pharmacokinetics and Pharmacodynamics of MKP10241 following multiple doses in obese adult participants Day 1, 2, 28 and 29 Pharmacodynamic parameters - leptin levels pre-dose, 0.25 hours, 0.5 hours, 1.0 hour, 2.0 hours, 3.0 hours, 4.0 hour, 6.0 hours, 8.0 hours, and 12 hours on Day 1 and 28, and 24 hours post-dose on Day 2 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 Pharmacodynamic parameters - Triglyceride
Part 2 - Pharmacokinetics and Pharmacodynamics of MKP10241 following multiple doses in obese adult participants. At baseline and Day 28 Pharmacodynamic parameters - Lipase
Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM 35 days Pharmacokinetic parameter evaluation - Area under the curve from time 0 extrapolated to infinity AUC(0-inf)
Trial Locations
- Locations (1)
Veritus Research
🇦🇺Bayswater, Victoria, Australia
Veritus Research🇦🇺Bayswater, Victoria, AustraliaStephen Hall, MBBS,MDContact03 8736 1758 Or 0494 062 402info@veritusresearch.com