MedTrace Logo

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

NCT01910571 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2014-11-26

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

P7435

OTHER

Placebo

Sponsors & Collaborators

  • Profil Institute for Clinical Research, Inc.

    collaborator OTHER

  • Piramal Enterprises Limited

    lead INDUSTRY

Principal Investigators

  • Dr. Elaine Watkins · Profil Institute for Clinical Research, Inc.

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01910571 on ClinicalTrials.gov