96
Participants
Start Date
June 30, 2013
Primary Completion Date
October 31, 2015
Study Completion Date
December 31, 2015
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."
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"
RECRUITING
Phase I clinic: MRA Clinical Research, Miami
Collaborators (1)
Quintiles, Inc.
INDUSTRY
Miami Research Associates
NETWORK
Piramal Enterprises Limited
INDUSTRY