Food Effect, Efficacy and Safety of MKP10241 in Healthy and Obese Adult Participants, With and Without Diabetes

ConditionsType 2 Diabetes Mellitus (T2DM)Food Effect Safety and Tolerability Obesity

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-60

SponsorMankind Pharma Limited

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male or female participants between 18 to 60 years of age

Considered healthy by the Investigator. Part 1: BMI of 18 to 30 kg/m2, and weight being not less than 50 kg. Part 2/3: BMI of ≥32 kg/m2

Part 1/2: Fasting plasma glucose (FPG) between 3.9 mmol/L and 6.1 mmol/L. Part 3: FPG greater than or equal to 6.94 mmol/L and less than or equal to 14.43 mmol/L

A nonsmoker/social smoker, defined as not having smoked more than 5 cigarettes or equivalent per day in the 3 months prior to Screening.

Disqualifiers

Clinically significant haematological findings at Screening.

Hepatic impairment including aspartate aminotransferase (AST), alanine transaminase (ALT), or alkaline phosphatase ≥1.5 times upper limit of normal (ULN), total bilirubin ≥2.0 times ULN, albumin ≤3.0 g/L, serum amylase or lipase ≥1.5 times ULN at Screening.

Renal impairment, such as creatinine ≥ULN, estimated glomerular filtration rate (eGFR) of ≤80 mL/minute/1.73m2 in adults, as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula

Positive polymerase chain reaction (PCR) test for severe-acute-respiratory-syndrome-related coronavirus (SARS-CoV-2)

Trial design

Design model

Parallel

Treatments tested in this trial

MKP10241
Drug
Oral liquid suspension of unit dose strength 6.6 mg/mL
Placebo
Drug
Oral liquid suspension matched in appearance to MKP10241 at dosage strengths

Treatment groups

68 Participants

are divided into 6 treatment groups

Treatment groups

See each treatment group below.

Group A: Part 1- MKP10241 400 mgExperimental treatment 1 intervention

Group B: Part 1 - PlaceboPlacebo comparator 1 intervention

Group C: Part 2 - MKP10241 200 mg, 300 mg and 400 mgExperimental treatment 1 intervention

Group D: Part 2 - PlaceboPlacebo comparator 1 intervention

Group E: Part 3 - MKP10241 300 mg and 400 mgExperimental treatment 1 intervention

Group F: Part 3 - PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Part 1 - Food effect of single dose of MKP10241 on Maximum concentration of drug (Cmax)

Maximum concentration (Cmax) following a single 400 mg dose of MKP10241 under fasting and fed condition

Time frame

18 days

Part 1 - Food effect of single dose of MKP10241 on Apparent total clearance of drug (CL/F)

Total Clearance of the drug following a single 400 mg dose of MKP10241 under fasting and fed conditions

Time frame

18 days

Part 1 - Food effect of single dose of MKP10241 on Time to maximum concentration (Tmax)

Time to maximum concentration (Tmax) following a single 400 mg dose of MKP10241 under fasting and fed condition

Time frame

18 days

Part 1 - Food effect of single dose of MKP10241 on elimination half life (t1/2 )

Elimination Half life (t1/2) following a single 400 mg dose of MKP10241 under fasting and fed conditions

Time frame

18 days

Secondary outcomes

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.

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.

Time frame

18 days

Part 2 - Pharmacokinetics and Pharmacodynamics of MKP10241 following multiple doses in obese adult participants

Pharmacodynamic parameters - To evaluate surrogate markers of efficacy and mechanism of action in obese participants the below will be measured: Change in Heart Rate in beats per minute

Time frame

Baseline to Day 28

Part 2 - Pharmacokinetics and Pharmacodynamics of MKP10241 following multiple doses in obese adult participants

Pharmacodynamic parameters - To evaluate surrogate markers of efficacy and mechanism of action in obese participants given in the below will be measured: Change in body weight in kilograms

Time frame

Baseline to Day 28

Part 2 - Pharmacokinetics and Pharmacodynamics of MKP10241 following multiple doses in obese adult participants

Pharmacodynamic parameters - To evaluate surrogate markers of efficacy and mechanism of action in obese participants given in the below will be measured: Change in BMI in kilograms per meter square

Time frame

Baseline to Day 28

Other outcomes

Part 2 - Impact of multiple doses of MKP10241 administered to obese participants without T2DM on participant Hunger and Satiety Visual Analogue Scale

Will be checked for change in participant Hunger and Satiety VAS score on Day 14 and Day 28 from baseline Participants will be asked to make a mark on a scale to indicate their hunger levels. The distance along line where the participant made their mark will be used as the measure. The distance in mm the participant marks on the scale will be used as a quantitative measure.Shorter means not hungry at all and higher means more hungry.

Time frame

Day 14 and Day 28 from baseline

Part 2 - Impact of multiple doses of MKP10241 administered to obese participants without T2DM on participant Visceral fat

Visceral fats will be measured by MRI-PDFF. The change in magnetic resonance derived proton density visceral fat fraction i.e. percentage of fat in the whole abdominal region will be measured.

Time frame

Baseline to Day 32

Part 3 - Impact of multiple doses of MKP10241 administered to obese participants with T2DM on participant Hunger levels and Satiety Visual Analogue Scale.

Will be checked for change in participant Hunger and Satiety VAS score on Day 14 and Day 28 from baseline(Day- 1) Participants will be asked to make a mark on a scale to indicate their hunger levels. The distance along line where the participant made their mark will be used as the measure. The distance in mm the participant marks on the scale will be used as a quantitative measure. Shorter means not hungry at all and higher means more hungry.

Time frame

Day 14 and Day 28 from baseline.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mankind Pharma Limited

Lead sponsor

Emerald Clinical Inc.

Collaborator

Source ClinicalTrials.gov

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