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

PHASE1UnknownINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

June 30, 2013

Primary Completion Date

October 31, 2015

Study Completion Date

December 31, 2015

Conditions
OverweightDiabetes Mellitus Type 2 in Obese
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"

Trial Locations (1)

33143

RECRUITING

Phase I clinic: MRA Clinical Research, Miami

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Quintiles, Inc.

INDUSTRY

collaborator

Miami Research Associates

NETWORK

lead

Piramal Enterprises Limited

INDUSTRY

NCT01874366 - Determination of Safety,Tolerability,Pharmacokinetics,Food Effect& Pharmacodynamics of Single & Multiple Doses of P11187 | Biotech Hunter | Biotech Hunter