| CTRI Number |
CTRI/2016/01/006507 [Registered on: 11/01/2016] Trial Registered Prospectively |
| Last Modified On: |
05/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study to evaluate the effects of new drug of diabetes mellitus in healthy volunteers. |
|
Scientific Title of Study
|
A safety, pharmacokinetics and pharmacodynamics study of CPL-2009-0031 in healthy volunteers and patients with Type 2 Diabetes mellitus (T2DM). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CRSC12015 Version-01, dated 22/08/13 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramesh Goyal |
| Designation |
Consultant Diabetologist (MD, DM) |
| Affiliation |
Apollo Hospitals International Limited |
| Address |
Apollo Hospitals International Limited, Gandhinagar, India
Gandhinagar
GUJARAT
382428
India |
| Phone |
9879512438 |
| Fax |
|
| Email |
ramogoyal@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akhil Sanghal |
| Designation |
Medical Monitor |
| Affiliation |
Cadila Pharmaceuticals Limited |
| Address |
Cadila Pharmaceuticals Limited
1389, Trasad Road, Dholka, Ahmedabad, Gujarat, India
Ahmadabad
GUJARAT
387810
India |
| Phone |
9099028164 |
| Fax |
|
| Email |
akhil.sanghal@cadilapharma.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akhil Sanghal |
| Designation |
Medical Monitor |
| Affiliation |
Cadila Pharmaceuticals Limited |
| Address |
Cadila Pharmaceuticals Limited
1389, Trasad Road, Dholka, Ahmedabad, Gujarat, India
Ahmadabad
GUJARAT
387810
India |
| Phone |
9099028164 |
| Fax |
|
| Email |
akhil.sanghal@cadilapharma.co.in |
|
|
Source of Monetary or Material Support
|
| Cadila Pharmaceuticals Ltd.
1389, Trasad Road, Dholka,
Ahmedabad – 387810,
Gujarat, India.
|
|
|
Primary Sponsor
|
| Name |
Cadila Pharmaceuticals Ltd |
| Address |
1389, Trasad Road, Dholka,
Ahmedabad-387810
Gujarat |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramesh Goyal |
Apollo Hospitals International Limited |
AHREF Department, Ground floor, Apollo Hospitals International Limited, Gandhinagar, India
Gandhinagar
GUJARAT |
9879512438
ramogoyal@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Apollo Hospitals International Limited |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Stage 1: Healthy Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CPL-2009-0031 |
Cohort (Dose-level) -I: CPL-2009-0031 (35mg) and its matching placebo
Cohort (Dose-level) –II: CPL-2009-0031 (70mg) and its matching placebo
Cohort (Dose-level) –III: CPL-2009-0031 (140mg)
Single dose
|
| Comparator Agent |
Matching placebo of respective dose in each cohort |
Single dose |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Male |
| Details |
Stage I
 Subject willing to comply with the protocol and has signed ethics committee approved informed consent form (ICF).
 Healthy adult male within age group of 18-55 years
 BMI in the range of 18.5 – 24.9 kg/m2
 No hypersensitivity or contraindication to DPP-IV inhibitors or excipients of investigational drug formulation
 Free of any acute/chronic illness
 Subjects who are in good health at the time of entry into the study as determined by medical, medication and hypersensitivity histories, clinical examination, vital sign measurements, chest X-ray, 12-lead ECG measurement and clinical judgment of the investigator.
 Documented negative test for human immuno virus (HIV-1/2), Hepatitis B surface antigen (HBsAg) and Hepatitis C virus (HCV).
 Sexually active male subject with partners of childbearing potential must practice acceptable barrier contraception during the treatment and at least 2 months after the last dose to prevent his partner from becoming pregnant during the study. |
|
| ExclusionCriteria |
| Details |
 History or currently consuming drugs of abuse or alcohol.
 Subjects who has received any drug other than OTC product within 30 days of dosing or any OTC product 7 days prior to dosing
 Participation in another clinical trial in the past 3 months.
 Subject with an abnormal clinical chemistry, hematology or urinalysis results that is considered clinically significant by the investigator or the sponsor.
 Subjects with history of smoking or currently having smoking habit will not be included in the study.
 History of hypotensive episodes, or systolic blood pressure reading of <100 mm Hg or a diastolic reading of <60 mm Hg at time or history of hypertension, or systolic blood pressure reading of >139 mm Hg or a diastolic reading >89 mm Hg at time of general physical examination.
 Xanthine-containing food or beverages (tea, coffee, chocolates, soft drinks like cola etc.) within 24 hours prior to the dosing of each period or alcoholic products consumption within 48 hours prior to the dosing of each period.
 Subjects otherwise judged by the investigators or sub-investigator to be inappropriate for inclusion in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Stage I : To evaluate safety and tolerability of CPL-2009-0031 at its single-escalating doses, by observing:
1. Frequency of Serious adverse events
2. Number and severity of hypoglycemic events
|
Safety will be observed till 7 days post-dose. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Stage I: To determine safety, tolerability and pharmacokinetics of CPL-2009-0031 at its single-escalating dose.
Frequency and severity of adverse events
Number and severity of clinically significant laboratory values
Pharmacokinetic parameters: Cmax, AUC0-t, AUC0-inf, Tmax, t1/2, Kel, Vd, CL/F |
Adverse events will be observed till 7 days post-dose.
Laboratory investigations will be performed at screening and day 7.
Pharmacokinetic parameters: Blood sampling for PK assessment will be done at pre-dose (0.00 Hr) and at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0, 24.0,48.0,72.0 Hr post-dose. |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
18/01/2016 |
| Date of Study Completion (India) |
13/02/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
13/02/2016 |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Present study is safety, pharmacokinetic and pharmacodynamic study of CPL-2009-0031. Stage I of study will be conducted in healthy volunteers. The primary objectives for stage-I of the present study is to evaluate safety and tolerability of CPL-2009-0031 at its single-escalating doses. In Stage I, 12 subjects will be randomized in 3:1 randomization ratio (CPL-2009-0031 against its matching placebo, respectively) for each of following cohort: Cohort (Dose-level) -I: CPL-2009-0031 (35mg) and its matching placebo Cohort (Dose-level) –II: CPL-2009-0031 (70mg) and its matching placebo Cohort (Dose-level) –III: CPL-2009-0031 (140mg) and its matching placebo After an overnight fasting of at least 10 hours, subjects will be administered study drugs with 240 ml of water. Subjects will remain in the study center for a period of 24 hours post-dosing to monitor safety aspects and to collect blood samples for pharmacokinetic analysis. The study duration for subject will be 7 days post-dosing. Adverse events will be monitored throughout the study (days- 0 to 7) by investigator inquiries and spontaneous reports. They will be recorded in terms of symptoms and signs, duration, severity, relationship with the study drug, action taken, and seriousness. In addition, physical examinations, vital sign measurements (blood pressure, heart rate, respiratory rate and oral temperature), 12-lead ECGs, and clinical laboratory tests will be used to determine adverse events and clinically significant laboratory values. The physical examination and vital sign measurements will be performed at pre-dose and at 2.0, 4.0, 6.0, 12.0, 24.0, 48.0, 72.0 and 168.0 h post-dose. 12-lead ECG will be performed at 2.0, 4.0, 12.0, 24.0, 48.0, 72.0 and 168.0 h post-dose. Hematology, blood biochemistry and urine R/M analysis will be performed at 168.0 h post-dose as a part of post-dose laboratory safety assessments. Blood glucose will be monitored by appropriate and validated glucometer at 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0 h post-dosing. Apart from these time-points, investigator may call for the safety assessments at any time, as and when required. 4 ml of blood sampling for the analysis of plasma CPL-2009-0031 and sitagliptin will be performed within 1 hour prior to dosing (0.0 h) and at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0, 24.0, 48.0, 72.0 h post-dose from an indwelling cannula inserted in a forearm vein into an EDTA-2K-containing tube. Intravenous indwelling cannula will be kept in situ as long as possible by injecting, The plasma CPL-2009-0031 and sitagliptin will be quantified using LC-MS/MS method. For laboratory investigations at screening (15.0 ml) and post-study safety evaluations (5 ml), blood will be collected in EDTA vacutainers. |