Study Of Single Ascending Doses Of PBL 1427 In Healthy Volunteers
Recruitment status was: Recruiting
|Diabetes Mellitus||Drug: Matching placebo Drug: PBL 1427 capsules||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Number of subjects with adverse events [ Time Frame: Pre-dose and upto Day 5-9 ]Safety and tolerability of PBL 1427 will be assessed after single ascending doses when administered alone on the basis of AEs, vital signs (BP, pulse rate, and body temperature), ECG, laboratory parameters and clinical assessment.
- Pharmacokinetics Variables (Cmax, tmax, AUC, t1/2, kel, CL/F & Vz/F) [ Time Frame: 48 hrs post dose ]Pharmacokinetic parameters of single ascending doses of PBL 1427 : For each subject, blood will be collected at the following time points: pre-dose, 0.25, 0.50, 0.75 1, 1.5, 2, 3, 4, 6, 8, 10, 14, 16, 20, 24, 36 and 48 h post-dose.
- Pharmacodynamics assessment (glucose, insulin, C-peptide, lactic acid) [ Time Frame: Pre-dose and upto 4 h post-dose ]Pharmacodynamics will be assessed using markers like glucose, insulin, C-peptide, lactic acid and the exploratory markers plasma DPP-IV activity and plasma GLP-1 (Glucagon-like peptide I) levels
- Exploratory markers (plasma DPP-IV activity and GLP-1 levels) [ Time Frame: Pre-dose and upto 48 h after dosing ]Pharmacodynamics will be assessed using markers like glucose, insulin, C-peptide, lactic acid and the exploratory markers plasma DPP-IV activity and plasma GLP-1 (Glucagon-like peptide I) levels
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
|Experimental: PBL 1427 capsules||
Drug: PBL 1427 capsules
PBL 1427 capsules 20 mg and 150 mg, single dose
|Placebo Comparator: Matching placebo||
Drug: Matching placebo
Matching Placebo, single dose
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01554293
|Contact: Dr Deepak C Chilkoti||+91-129-4090 900||Deepak.firstname.lastname@example.org|
|Fortis Clinical Research Ltd||Recruiting|
|Faridabad, Haryana, India, 121 002|
|Contact: Dr Deepak C Chilkoti +91-129-4090 900 Deepak.email@example.com|
|Principal Investigator: Dr Deepak C Chilkoti|
|Principal Investigator:||Dr Deepak C Chilkoti||Head-Clinical Operations|