Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2026-02-20 @ 11:18 AM
Study NCT ID:
NCT01874366
Status:
UNKNOWN
Last Update Posted:
2014-08-28
First Post:
2013-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determination of Safety,Tolerability,Pharmacokinetics,Food Effect& Pharmacodynamics of Single & Multiple Doses of P11187
Sponsor:
Piramal Enterprises Limited
Organization:
Study Overview
Official Title:
A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Safety, Tolerability, Pharmacokinetics, Food Effect and Pharmacodynamics of Single and Multiple Ascending Doses of P11187
Status:
UNKNOWN
Status Verified Date:
2014-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
* 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
Detailed Description:
* In Part I, the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses of P11187 will be studied in healthy, overweight or obese, male and females (of non-child bearing potential) subjects. There will be up to 6 cohorts of 8 subjects each. At each dose level, 6 subjects will receive a single dose of active treatment, P11187 and 2 subjects will receive a single dose of matching placebo. It is planned that up to 6 dose levels of P11187 may be evaluated after single dose administration.
* In Part II, the safety, tolerability, PK and PD of multiple ascending doses of P11187 administered once daily for 14 consecutive days will be studied in overweight or obese, male and female of non-child bearing potential subjects with type 2 diabetes mellitus. Up to 3 dose levels of P11187 are planned to be evaluated in 3 cohorts of 12 subjects each for 14 days.At each dose level, 9 subjects will receive the active drug, P11187 and 3 subjects will receive matching placebo, once daily for a period of 14 days.
* In Part III, the food effect evaluation of P11187 will be performed in a randomized, open-label, cross-over, two-period study at a single dose level in a cohort of 12 healthy male subjects to be administered the drug under fasted and fed conditions.Subjects will be administered a single dose of P11187 in Periods 1 and 2 under fasted and fed conditions as per the randomization schedule, with a wash-out interval of 7-10 days between the two periods. Subjects who have received the study drug, P11187 under fasted conditions in Period 1 will cross-over and receive the study drug under fed conditions in Period 2 and vice versa.
* In Part II, the safety, tolerability, PK and PD of multiple ascending doses of P11187 administered once daily for 14 consecutive days will be studied in overweight or obese, male and female of non-child bearing potential subjects with type 2 diabetes mellitus. Up to 3 dose levels of P11187 are planned to be evaluated in 3 cohorts of 12 subjects each for 14 days.At each dose level, 9 subjects will receive the active drug, P11187 and 3 subjects will receive matching placebo, once daily for a period of 14 days.
* In Part III, the food effect evaluation of P11187 will be performed in a randomized, open-label, cross-over, two-period study at a single dose level in a cohort of 12 healthy male subjects to be administered the drug under fasted and fed conditions.Subjects will be administered a single dose of P11187 in Periods 1 and 2 under fasted and fed conditions as per the randomization schedule, with a wash-out interval of 7-10 days between the two periods. Subjects who have received the study drug, P11187 under fasted conditions in Period 1 will cross-over and receive the study drug under fed conditions in Period 2 and vice versa.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: