drugset / Trial / NCT01910571
Study to Determine the Safety, Tolerability, Pharmacokinetics, Food Effect and Pharmacodynamics of Single and Multiple Ascending Doses of P7435 in Healthy, Overweight or Obese Subjects
Phase 1
Completed
100 enrolled
Piramal Enterprises Limited
Profil Institute for Clinical Research, Inc. · collab
RandomizedCrossoverDouble-blind
Summary
* This is a single centre, phase I, randomized, double-blind, placebo-controlled, crossover, dose escalating study of P7435 using single and multiple doses, to be conducted in healthy male and female (Non child bearing) subjects having BMI between 19 to 40 kg/m2. * The study will be conducted in 2 parts as follows: Part A will consist of the Single Ascending Dose (SAD) study and Part B will consist of the Multiple Ascending Dose (MAD) study.
Timeline
- Start
- 2013-08
- Primary completion
- 2014-11
- Completion
- 2014-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | P7435 | Unknown | — | — |
Indications
No indication recorded.