A Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ZYD1, Following Subcutaneous Administration in Healthy Volunteers
NCT ID: NCT01972893
Last Updated: 2013-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
56 participants
INTERVENTIONAL
2011-02-28
2012-06-30
Brief Summary
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ZYD1 is a potent antidiabetic agent without gastrointestinal side-effects. A first in human (FIH) Phase I study intends to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ZYD1 in normal healthy adult volunteers.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ZYD1
Tablet ZYD1 5 to 50 mg subcutaneously Once a day (OD) or BID depending upon the pharmacokinetic profile obtained in Plan I (Single dose study)
ZYD1
Plan I - Tablet ZYD1 - 0.5, 1 , 2, 5, 10, 25 and 50 mg subcutaneously OD after overnight fasting.
Plan II - Tablet ZYD1 - 0.5, 1 , 2, 5, 10 and 25 mg subcutaneously OD after overnight fasting.
Plan III - Tablet ZYD1 2/5 mg subcutaneously OD after overnight fasting depending on results of Plan I.
Placebo
Tablet Placebo 5 to 50 mg subcutaneously OD or BID depending upon the pharmacokinetic profile obtained in Plan I (Single dose study)
Placebo
Plan I - Tablet Placebo - 0.5, 1 , 2, 5, 10, 25 and 50 mg subcutaneously OD after overnight fasting.
Plan II - Tablet Placebo - 0.5, 1 , 2, 5, 10 and 25 mg subcutaneously OD after overnight fasting.
Plan III - Tablet Placebo 2/5 mg subcutaneously OD after overnight fasting depending on results of Plan I.
Interventions
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ZYD1
Plan I - Tablet ZYD1 - 0.5, 1 , 2, 5, 10, 25 and 50 mg subcutaneously OD after overnight fasting.
Plan II - Tablet ZYD1 - 0.5, 1 , 2, 5, 10 and 25 mg subcutaneously OD after overnight fasting.
Plan III - Tablet ZYD1 2/5 mg subcutaneously OD after overnight fasting depending on results of Plan I.
Placebo
Plan I - Tablet Placebo - 0.5, 1 , 2, 5, 10, 25 and 50 mg subcutaneously OD after overnight fasting.
Plan II - Tablet Placebo - 0.5, 1 , 2, 5, 10 and 25 mg subcutaneously OD after overnight fasting.
Plan III - Tablet Placebo 2/5 mg subcutaneously OD after overnight fasting depending on results of Plan I.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Mentally, physically, and legally eligible to give informed consent
3. Male and female volunteers weighing between 50-75 kg and 45-75 kg respectively
4. Ability to communicate effectively with the study personnel
5. Willingness to adhere to the protocol requirements
6. For gender effect study, only females with history of sterility or at least 1 year menopause or use of long acting nonhormonal contraceptive measures (e.g., intrauterine device) will be recruited.
Exclusion Criteria
2. Presence or history of pancreatitis at any time (Serum Amylase/Serum Lipase more than upper normal limit (UNL))
3. Presence or history of severe gastrointestinal disease in the last 6 months
4. Presence or history of renal insufficiency at any time (serum creatinine above the upper limit of the reference range)
5. Active liver disease and/or liver transaminases greater than 1.5 X UNL
6. Subject with personal or family history of medullary thyroid cancer
7. Subject with personal or family history of multiple endocrine neoplasia syndrome type 2
8. Subject with serum calcitonin \>50 ng/L
9. 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)
10. Abnormal bleeding time (BT), clotting time (CT), prothrombin time (PT), and activated partial prothrombin time (APTT) tests on the day of check in
11. History or presence of any medication in the last 14 days including any medication known to interact with the Cytochrome P (CYP) 450 system
12. History or presence of significant alcoholism or drug abuse within the past 1 year
13. History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco products (more than 10 times per day)
14. Difficulty with donating blood
15. Systolic blood pressure more than 140 mmHg and less than 100 mmHg and diastolic blood pressure more than 90 mmHg and less than 60 mmHg
16. Pulse rate less than 60/minute and more than 100/minute
17. Any clinically significant abnormal X-ray or laboratory findings during screening
18. History or presence of any clinically significant electrocardiogram (ECG) abnormalities during screening
19. Major illness and/or major surgery in last 3 months
20. Volunteers who have participated in any drug research study other than the present trial within past 3 months
21. Volunteers who have donated one unit (350 ml) of blood in the past 3 months
22. 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 device or history of less than 1 year of menopause
* 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
18 Years
45 Years
ALL
Yes
Sponsors
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Zydus Lifesciences Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Rajendrakumar H Jani, PhD(Medical)
Role: STUDY_DIRECTOR
Senior Vice President - Cadila Healthcare Limited
Kevinkumar Kansagra, MD
Role: PRINCIPAL_INVESTIGATOR
Zydus Research Centre
Locations
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Zydus Research Centre, Survey No. 396/403, Opp. Sarvotam Hotel, Nr. Nova Petrochemicals, Sarkhej-Bavla N.H. No. 8A, Village : Moraiya,
Ahmedabad, Gujarat, India
Countries
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Other Identifiers
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CTRI/2011/04/001684
Identifier Type: OTHER
Identifier Source: secondary_id
ZYD1/1001
Identifier Type: -
Identifier Source: org_study_id