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Determination of Safety,Tolerability,Pharmacokinetics,Food Effect& Pharmacodynamics of Single & Multiple Doses of P11187

NCT01874366 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2014-08-28

No results posted yet for this study

Summary

* Study to Determine the Safety, Tolerability, Pharmacokinetics, Food Effect and Pharmacodynamics of Single and Multiple Ascending Doses of P11187
* It will be conducted in three parts, as described below:
* Part I will be the Single Ascending Dose (SAD) study
* Part II will be the Multiple Ascending Dose (MAD) study
* Part III will be the food effect evaluation

Conditions

Interventions

DRUG

P11187

* Part I: Step wise dose escalation(10 to 1500 mg, qd, Oral) * Part II: Step wise dose escalation in multiple dosing (≤ 1500 mg, qd, Oral) for 14 consecutive days. * Part III: Study drug administered (≤ 1500 mg, qd, Oral) under fasted or fed conditions in two different periods separated by a wash-out interval.

DRUG

Placebo

Placebo capsules will be matching in appearance with the active drug capsules of P11187. * In Part I, there will be up to 6 cohorts of 8 subjects each in single dose assessment. Two subjects from each cohort will be dosed with placebo * In Part II, there will be 3 cohorts of 12 subjects each and three subjects from each cohort will be dosed with placebo

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Miami Research Associates

    collaborator NETWORK

  • Piramal Enterprises Limited

    lead INDUSTRY

Principal Investigators

  • Patricia Pardo,, MD · Phase I clinic: MRA Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-10-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT01874366 on ClinicalTrials.gov