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CTRI Number  CTRI/2011/12/002220 [Registered on: 13/12/2011] Trial Registered Prospectively
Last Modified On: 30/07/2012
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Phase 1 clinical trial of PBL 1427 in healthy volunteers.  
Scientific Title of Study   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. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
PBL/CR/2011/05/CT  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deepak C Chilkoti 
Designation  Head-Clinical Operations 
Affiliation  Fortis Clinical Research Ltd 
Address  Fortis Clinical Research Ltd Sunflag Hospital & Research Centre Sector 16-A, Faridabad – 121 002, Haryana, INDIA Tel: +91-129-4090 900

Faridabad
HARYANA
121002
India 
Phone  0129-4090900  
Fax    
Email  Deepak.chilkoti@fortis-cro.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arani Chatterjee 
Designation  Sr Vice President-Clinical Research 
Affiliation  Panacea Biotec Ltd 
Address  Panacea Biotec Ltd B-1 Ext/G-3, MCIE, Mathura Road, New Delhi

New Delhi
DELHI
110044
India 
Phone  011-41679000  
Fax  011-41678085  
Email  aranichatterjee@panaceabiotec.com  
 
Details of Contact Person
Public Query  
Name  Dr Arani Chatterjee 
Designation  Sr Vice President-Clinical Research 
Affiliation  Panacea Biotec Ltd 
Address  Panacea Biotec Ltd B-1 Ext/G-3, MCIE, Mathura Road, New Delhi


DELHI
110044
India 
Phone  011-41679000  
Fax  011-41678085  
Email  aranichatterjee@panaceabiotec.com  
 
Source of Monetary or Material Support  
Panacea Biotec Ltd 
 
Primary Sponsor  
Name  Panacea Biotec Ltd 
Address  Panacea Biotec Limited B-1 Ext./G-3, M.C.I.E., Mathura Road, New Delhi-110044, Phone: 91-11-41679000  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Panacea Biotec Ltd  Panacea Biotec Limited B-1 Ext./G-3, M.C.I.E., Mathura Road, New Delhi-110044, Phone: 91-11-41679000  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deepak C Chilkoti  Sunflag Hospital & Research Centre  ICU of Sunflag Hospital & Research Centre, Fortis Clinical Research Ltd Sector 16-A, Faridabad – 121 002, Haryana, INDIA Tel: +91-129-4090 900
Faridabad
HARYANA 		 0129-4090900

Deepak.chilkoti@fortis-cro.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sentinel Independent Ethics Committee (SIEC), New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  This drug is expected to be useful in Type 2 diabetes mellitus  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  PBL 1427  The study will consist of six dose groups of eight subjects each in which six subjects will receive a single dose of active treatment (PO) and two subjects will receive placebo as a single dose. 
Comparator Agent  Placebo  The study will consist of six dose groups of eight subjects each in which six subjects will receive a single dose of active treatment and two subjects will receive placebo (PO) as a single dose. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  Subjects to be enrolled in this trial must fulfil all of these criteria:
• Sex: male
• Age: 18-60 yr old, both inclusive
• Having a Body Mass Index (BMI) between 18.5-28 kg / m2 (both inclusive) and body weight not less than 45 kg
• Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; and to comply with the requirements of the entire study
• Voluntarily given written informed consent to participate in this study
• Be of normal health as determined by the principal investigator from medical history, physical examination and laboratory investigations, 12- lead ECG and X-ray chest of the subjects performed within 10 days prior to the admission of the study
• Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, coke, chocolate, “power drinks”) and grapefruit (juice) from 48 h prior to each admission until study completion
 
 
ExclusionCriteria 
Details  Subjects meeting any of these criteria will not be enrolled in the study:
• Employees of FCRL or PBL
• Not willing to use contraceptives (preferably condoms) during sexual activity for the period of 3 months from the date of check-in
• History of hypersensitivity and / or intolerance to Dipeptidyl peptidase (DPP)-IV inhibitors or any other related compounds.
• History of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study.
• Clinically abnormal ECG and Chest X-ray.
• Physical findings: clinically relevant abnormal physical findings (including body temperature) suggesting underlying pathologies or those which could interfere with the objectives of the study.
• Gastrointestinal disorders likely to influence drug absorption including acute gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea, heart burn), preceding one week to admission.
• Laboratory values that are significantly different than the normal reference range and/or are deemed to be of clinical significance by the investigator
• Presence of reactive disease markers of HIV 1 and II, HBsAg,, HCV or VDRL.
• Positive for alcohol breath test and/or urine drug screen (barbiturates, benzodiazepines, amphetamine, cocaine, opiates, tetra-hydro cannabinol).
• Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
• History of Diabetes Mellitus or intake of any anti-diabetic medication
• Diseases: relevant history of renal, hepatic, cardiovascular, respiratory, skin, haematological, endocrine, neurological or gastrointestinal diseases. History of depression, psychosis, schizophrenia or any other severe psychiatric diseases, or epilepsy, or any other illness that may interfere with the aim of the study. History of any significant illness in the 4 weeks preceding the screening
• Medications: history of intake of any medications including over the counter medications (OTC) during the 4 weeks period prior to dosing with the IMP.
• Investigational drug trials: participation in the evaluation of any drug in the 3 months prior to the start of the study (dosing with IMP).
• Blood donation: Subjects who, through completion of this study, would have donated and/or lost more than 300 mL of blood in the past 12 weeks

Note: In case the blood loss is ≤ 200 mL; subject may be dosed 60 days after blood donation or
last sample of the previous study
• Regular smokers who smoke more than 10 cigarettes daily or have difficulty abstaining from smoking for the duration of each study period.
• History of drug dependence or alcoholics
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To determine safety and tolerability of PBL 1427
2. To evaluate the pharmacokinetics (PK) of PBL 1427
 		 The subjects will be confined to the unit, approximately 10.5 hours before drug administration and until 48 h post-dose. Subjects will be housed from admission and prior to dosing at FCRL and will be shifted to Sunflag Hospital ICU well advance in time before dosing and will be housed there till discharge. Subsequent follow ups and all laboratory tests (at day 05 to day 09) will be carried out at FCRL screening area in all the cohorts. 
 
Secondary Outcome  
Outcome  TimePoints 
To determine pharmacodynamic markers of PBL 1427 in the study population  The subjects will be confined to the unit, approximately 10.5 hours before drug administration and until 48 h post-dose. Subjects will be housed from admission and prior to dosing at FCRL and will be shifted to Sunflag Hospital ICU well advance in time before dosing and will be housed there till discharge. Subsequent follow ups and all laboratory tests (at day 05 to day 09) will be carried out at FCRL screening area in all the cohorts. 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   16/01/2012 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

A total of 48 healthy male subjects will be enrolled in six cohorts. (Two additional subjects will be included in each cohort and will be housed till dosing to handle any withdrawn or drop out before dosing). The study will consist of six dose groups of eight subjects each in which six subjects will receive a single dose of active treatment and two subjects will receive placebo as a single dose. Subjects will be dosed in subsequent dose levels only after safety evaluation of subjects recruited in the previous dose level. The post-study period (follow-up) will be done on Day 5-9 post dose.

The subjects will undergo a screening procedure that will be valid for a period of 10 days prior to the day of admission. The subjects will be confined to the unit, approximately 10.5 hours before drug administration and until 48 h post-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.

 

 
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