Clinical trial to study the safety tolerability, pharmacokinetics, food effect and pharmacodynamics of a new compound P7435 in in healthy, overweight and/or obese subjects
* A phase I, randomized, double-blind, placebo-controlled, dose escalating study of P7435 to determine the safety, tolerability, pharmacokinetics, food effect and pharmacodynamics of single and multiple ascending doses of P7435. * Subjects participating will be either healthy subjects or healthy overweight and/or obese subjects. In this study, overweight/obese are defined as subjects having a BMI of 23 kg/m2 and above. * The study will be conducted in 3 parts as follows: Part A will consist of the Single Ascending Dose (SAD) study, Part B will consist of the Multiple Ascending Dose (MAD) study and Part C will consist of the Food Effect study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
It is oral DGATI inhibitor with potential in dyslipidemia and T2DM
Piramal Clinical Research
Hyderabad, Andhra Pradesh, India
Veeda Clinical Research
Ahmedabad, Gujarat, India
Number of participants with adverse events
\- Number of participants with adverse events in the single and multiple ascending dose studies.
Time frame: Up to Day 5
Effect of food on drug concentrations
Time frame: Day 1
Pharmacokinetics profile (Cmax, Tmax, and AUC)
* The PK profile will be derived from the P7435 plasma concentration data. * A non compartmental model will be used to analyze the plasma levels of P7435
Time frame: Day 1 and Day 14
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