NCT01764425

Clinical Trial to Study the Safety Tolerability, Pharmacokinetics, Food Effect & Pharmacodynamics of a New Compound P7435 in Healthy, Overweight and/or Obese Subjects

A Phase I, Randomized, Double-blind, Placebo-controlled Study to Determine the Safety, Tolerability, Pharmacokinetics, Food Effect and Pharmacodynamics of Single and Multiple Ascending Doses of P7435 in Healthy, Overweight and/or Obese Subjects

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Piramal Enterprises Limited · Industry
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

* 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.

Conditions

• Healthy, Overweight and/or Obese Subjects

Interventions

Type	Name	Description
DRUG	P7435	It is oral DGATI inhibitor with potential in dyslipidemia and T2DM

Timeline

• Start date: 2012-05-01
• Primary completion: 2012-09-01
• Completion: 2013-02-01
• First posted: 2013-01-09
• Last updated: 2013-07-09

Locations

2 sites across 1 country: India