Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT01554293
Status:
UNKNOWN
Last Update Posted:
2013-05-16
First Post:
2012-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Of Single Ascending Doses Of PBL 1427 In Healthy Volunteers
Sponsor:
Panacea Biotec Ltd
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Placebo-Controlled Phase I Study To Determine The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single Ascending Doses Of PBL 1427 In Healthy Volunteers
Status:
UNKNOWN
Status Verified Date:
2013-05
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:
PBL 1427 is a Dipeptidyl peptidase (DPP)-IV inhibitor being developed for treatment of type 2 diabetes. Although a number of DPP-IV inhibitors have been described, there still exists a need for new DPP-IV inhibitors that have better half-life, advantageous potency, stability and selectivity, less toxicity and/or better pharmacodynamic properties.
Detailed Description:
As per the randomization schedule, capsule(s) of A or B will be administered to each subject with 240 mL of water at ambient temperature. Subjects will be instructed not to chew or crush the capsule(s) but to consume it as a whole. Compliance for dosing will be assessed by a thorough check of the oral cavity immediately after dosing. Administration of investigational products will be carried out while the subjects are in sitting posture and they will be instructed to remain seated for two hours after dosing except when clinically indicated to change the posture or in case of any natural exigency. Thereafter, the subjects will be allowed to engage in normal activities while avoiding severe physical exertion.
The following treatments in the below cohorts will be followed as given below:
Cohort 1: A single oral dose of 20 mg of PBL 1427 (n=6) or placebo (n=2) Cohort 2: A single oral dose of 40 mg (20 mg X 2 capsules) of PBL 1427 (n=6) or placebo (n=2) Cohort 3: A single oral dose of 80 mg (20 mg X 4 capsules) of PBL 1427 (n=6) or placebo (n=2) Cohort 4: A single oral dose of 150 mg of PBL 1427 (n=6) or placebo (n=2) Cohort 5: A single oral dose of 300 mg (150 mg X 2 capsules) of PBL 1427 (n=6) or placebo (n=2) Cohort 6: A single oral dose of 600 mg (150 mg X 4 capsules) of PBL 1427 (n=6) or placebo (n=2)
Dose levels may be modified and intermediate dose levels might be tested to determine the maximum tolerated dose (MTD)
The number of cohorts, dose levels, frequency and conditions of administration for the subsequent cohort may be altered by the Principal investigator and Sponsor after evaluation of the results of the previous group.
The following treatments in the below cohorts will be followed as given below:
Cohort 1: A single oral dose of 20 mg of PBL 1427 (n=6) or placebo (n=2) Cohort 2: A single oral dose of 40 mg (20 mg X 2 capsules) of PBL 1427 (n=6) or placebo (n=2) Cohort 3: A single oral dose of 80 mg (20 mg X 4 capsules) of PBL 1427 (n=6) or placebo (n=2) Cohort 4: A single oral dose of 150 mg of PBL 1427 (n=6) or placebo (n=2) Cohort 5: A single oral dose of 300 mg (150 mg X 2 capsules) of PBL 1427 (n=6) or placebo (n=2) Cohort 6: A single oral dose of 600 mg (150 mg X 4 capsules) of PBL 1427 (n=6) or placebo (n=2)
Dose levels may be modified and intermediate dose levels might be tested to determine the maximum tolerated dose (MTD)
The number of cohorts, dose levels, frequency and conditions of administration for the subsequent cohort may be altered by the Principal investigator and Sponsor after evaluation of the results of the previous group.
Study Oversight
Has Oversight DMC:
True
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?: