| CTRI Number |
CTRI/2016/04/006885 [Registered on: 28/04/2016] Trial Registered Prospectively |
| Last Modified On: |
28/02/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical study to evaluate the safety, tolerability and pharmacokinetics of ZYDPLA1, a novel DPP- IV inhibitor, following oral administration in healthy volunteers. |
|
Scientific Title of Study
|
A randomized, double-blind, placebo-controlled Phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of ZYDPLA1, a novel DPP- IV inhibitor, following oral administration in healthy volunteers. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ZYDPLA1 1001 Ver. 4.1 dated 07 November 2014 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kevinkumar Kansagra |
| Designation |
Principal Scientist |
| Affiliation |
Zydus Research Centre |
| Address |
Survey No. 396/403, Opp. Sarvotam Hotel, Nr. Nova
Petrochemicals, Sarkhej-Bavla N.H. No. 8A, Village : Moraiya,
Ahmedabad, India
Ahmadabad
GUJARAT
382213
India |
| Phone |
912717665555 |
| Fax |
912717665355 |
| Email |
kevinkumarkansagra@zyduscadila.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R H Jani |
| Designation |
Senior Vice President |
| Affiliation |
Zydus Research Centre |
| Address |
Survey No. 396/403, Opp. Sarvotam Hotel, Nr. Nova
Petrochemicals, Sarkhej-Bavla N.H. No. 8A, Village : Moraiya,
Ahmedabad, India
Ahmadabad
GUJARAT
382213
India |
| Phone |
912717665555 |
| Fax |
912717665355 |
| Email |
clinical@zyduscadila.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R H Jani |
| Designation |
Senior Vice President |
| Affiliation |
Zydus Research Centre |
| Address |
Survey No. 396/403, Opp. Sarvotam Hotel, Nr. Nova
Petrochemicals, Sarkhej-Bavla N.H. No. 8A, Village : Moraiya,
Ahmedabad, India
Ahmadabad
GUJARAT
382213
India |
| Phone |
912717665555 |
| Fax |
912717665355 |
| Email |
clinical@zyduscadila.com |
|
|
Source of Monetary or Material Support
|
| Cadila Healthcare Limited. Zydus Research Centre, Survey No. 396/403, Opp. Sarvotam Hotel, Nr. Nova Petrochemicals, Sarkhej-Bavla N.H. No. 8A, Village: Moraiya, Ahmedabad 382213, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Cadila Healthcare Limited |
| Address |
Zydus Research Centre, Survey No. 396/403, Opp. Sarvotam Hotel,
Nr. Nova Petrochemicals, Sarkhej-Bavla N.H. No. 8A, Village: Moraiya Ahmadabad, Pincode- 382213 Gujarat, India |
| 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 KevinKumar Kansagra |
Zydus Research Centre |
Zydus Research Centre,
Survey No. 396/403, Opp. Sarvotam Hotel, Nr. Nova Petrochemicals, Sarkhej-Bavla N.H. No. 8A, Village :
Moraiya, Ahmedabad-382213 India
Ahmadabad
GUJARAT |
912717665555
912717665355
kevinkumarkansagra@zyduscadila.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE OF CIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NA, as healthy volunteers. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Orally given. |
| Intervention |
ZYDPLA1 Tablets |
DPP-IV inhibitor, ZYDPLA1 tablets shall be given in dose of 1, 5, 20, 100, 200 mg orally. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy male or female between 18 and 65 years of age.
2. Male subjects must agree to use one of the contraception methods during the study.
3. BMI within the range 18.0 – 30.0 kg/m2 BMI value should be rounded off to one significant digit after decimal point. BMI values should be rounded to the nearest integer (ex. 30.4 rounds down to 30, while 17.5 rounds up to 18).
4. Capable of giving written informed consent, which includes compliance with protocol.
5. QTc interval < 450msec
6. For gender effect study, only females with history of sterility or at least 1 year menopause or use of long acting non hormonal contraceptive measures (e.g., intrauterine device) will be recruited.
7. Negative Urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiates, methadone and
phencyclidine within 28 days prior to initiation of the study and prior to check-in. |
|
| ExclusionCriteria |
| Details |
1. Presence or history of pancreatitis at any time {Serum Amylase/ Serum Lipase more than significant upper normal limit (≥1.5X UNL)}.
2. Presence or history of severe gastrointestinal disease in the last 6 months
3. Presence or history of renal insufficiency at any time {Serum creatinine more than upper normal limit (UNL) }
4. Active liver disease and/or liver transaminases greater than 1.5 X UNL
5. History or presence of other systemic disorders or diseases (e.g., respiratory, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement)
6. History or presence of any medication in the last 14 days
7. History or presence of significant alcoholism or drug abuse within the past 1 year
8. History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco products (more than 10 times per day)
9. Difficulty with donating blood or difficulty in accessibility of veins.
10. Intolerance to venipuncture
11. Systolic blood pressure more than 150 mmHg and less than 100 mmHg and diastolic blood pressure more than 90 mmHg
12. Pulse rate less than 50/minute and more than 100/minute
13. Any clinically significant laboratory findings during screening as determined by the Principal Investigator
14. History or presence of any clinically significant electrocardiogram (ECG) abnormalities during screening
15. Major illness and/or major surgery in last 3 months
16. Volunteers who have participated in any drug research study other than the present trial within past 30 days. (Subjected to insurance that subject has not participated in long acting drug including new biological entities/new chemical entities/biosimilar products)
17. Volunteers who have donated one unit (450 mL) of blood in the past 3 months
18. Positive Alcohol breath analyzer at the time of Screening and Checkin
19. A positive hepatitis screen (includes subtype B and C) and/or a positive test result for HIV antibody and/or syphilis (RPR).
20. Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal investigator or Sub-investigator, could contraindicated the study participant’s participation in this study.
21. For gender effect study, female volunteers with following criteria will not be recruited:
-History of pregnancy or lactation in the past 3 months
-Fertile female volunteers not protected against pregnancy by adequate long-term anti-fertility measures
-History of less than 1 year of menopause and not using adequate long-term anti-fertility measures
-Using hormonal contraceptives
-Using hormone replacement therapy
-Unable to give assurance for protection against pregnancy for 3 months after the participation in this trial
-Positive urine pregnancy test on the day of check-in
-Positive serum β-hCG level at the screening visit |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Safety and tolerability parameters including adverse events, clinical, laboratory, electrocardiogram, and vital signs assessments. |
Clinical examination, vital signs like oral temperature, sitting blood pressure and pulse and laboratory tests will be done at screening
and at time points described as per protocol.
Continuous ECG monitoring and 12-lead ECG will be done as per time points described in the protocol.
Adverse event shall be monitored through out the study period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Pharmacokinetics (PK) after single and multiple oral dose
administrations in healthy male volunteers
2. Pharmacodynamic (PD) effect after single and multiple oral dose administrations in healthy male Volunteers
3. Gender effects: Pharmacokinetics and safety parameters in female volunteers at Preselected single dose will be compared with the results of similar single-dose study in male volunteers
4. Effect of food on pharmacokinetics and pharmacodynamics in male volunteers. |
The venous blood samples and urine samples will be collected for Pharmacokinetic concentration and pharmacodynamic effect measurement at defined time points as per protocol. |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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)
|
04/05/2016 |
| 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="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study will be a randomized, double-blind, placebo-controlled, multi-Centre trial. The objective of the study is to evaluate the safety, tolerability and pharmacokinetics of ZYDPLA1, a novel DPP- IV inhibitor, following oral administration in healthy volunteers. According to the dosage schedules, the study has been divided in the following four plans- Plan I: Single dose trial, Plan II: Multiple dose trial, Plan III: Gender effect trial, Plan IV: Food effect trial. An approximately 112 subjects shall be enrolled. At least one panel will be conducted in centre 2 (India) on selected dose from selected plan as per the study protocol. The volunteers, who are found normal and healthy at the time of screening, satisfy inclusion and exclusion criteria and are willing to give the informed consent, will be invited to participate in the study. Any adverse event (AE), either clinical/laboratory, will be recorded and assessed for severity, seriousness and causality. Frequency of AEs with ZYDPLA1 will be compared with the placebo group. Further dose escalation will be stopped as per stopping criteria. |