A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of Oral ZYGK1 in Healthy Volunteers

NCT ID: NCT01472809

Last Updated: 2015-11-24

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE1
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31

Brief Summary

The purpose of this study is to determine (1) whether ZYGK1 is safe and well tolerated, (2) the pharmacokinetics (what body does to ZYGK1) and (3) pharmacodynamics (what drugs does to the body) in the healthy and diabetic subject.

Detailed Description

This study will be a randomized, double blind, placebo controlled study and is divided into four plans:

1. Plan I: Single Ascending Dose (SAD) Study

2. Plan II: Multiple Ascending Dose (MAD)Study

3. Plan III: Gender Effect study

4. Plan IV: Food Effect study

First Plan I, Plan III and Plan IV will be conducted in healthy volunteers. After reviewing the results, decision shall be taken whether the multiple ascending doses shall be studied in healthy human volunteers or in subjects with type 2 diabetes.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo tablets

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo Tablets: 0.125, 0.25, 0.5, 1, 2, ... mg

ZYGK1

ZYGK1 tablets; 0.125, 0.25, 0.5, 1, 2, ... mg.

Dose escalation will continue till single AE occurs in any block of 3 volunteers on ZYGK1 or pharmacokinetic (dose linearity) saturation is reached or desired PK/PD effect is achieved

Group Type: EXPERIMENTAL

ZYGK1

Intervention Type: DRUG

ZYGK1 Tablets: 0.125, 0.25, 0.5, 1, 2, .... mg.

Dose escalation will continue till single AE occurs in any block of 3 volunteers on ZYGK1 or pharmacokinetic (dose linearity) saturation is reached or desired PK/PD effect is achieved

Interventions

ZYGK1

ZYGK1 Tablets: 0.125, 0.25, 0.5, 1, 2, .... mg.

Dose escalation will continue till single AE occurs in any block of 3 volunteers on ZYGK1 or pharmacokinetic (dose linearity) saturation is reached or desired PK/PD effect is achieved

Intervention Type: DRUG

Placebo

Placebo Tablets: 0.125, 0.25, 0.5, 1, 2, ... mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age: 18-45 years

2. Mentally, physically, and legally eligible to give informed consent

3. Male and female volunteers weighing between 50-75 kg and 45-75 kg (4) 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 one year menopause or use of long acting nonhormonal contraceptive measures (e.g., intrauterine device) will be recruited.

7. At least one panel, in single ascending dose and multiple ascending dose will include subjects with type 2 diabetes as defined by American Diabetes Association

Exclusion Criteria

1. Presence or history of hypersensitivity to any of the active or inactive ingredients of ZYGK1 formulation

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 >UNL)

5. Active liver disease and/or liver transaminases greater than 1.5 X UNL

6. 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)

7. Abnormal bleeding time (BT), clotting time (CT), prothrombin time (PT), and activated partial prothrombin time (APTT)

8. History or presence of any medication in the last 14 days

9. History or presence of significant alcoholism or drug abuse within the past 1 year

10. History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco products (more than 10 times per day)

11. Difficulty with donating blood

12. 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

13. Pulse rate less than 60 minute and more than 100/minute

14. Any clinically significant laboratory findings during screening

15. History or presence of any clinically significant electrocardiogram (ECG) abnormalities during screening

16. Major illness and/or major surgery in last 3 months

17. Volunteers who have participated in any drug research study other than the present trial within past 3 months

18. Volunteers who have donated one unit (350 ml) of blood in the past 3 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zydus Lifesciences Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rajendrakumar H Jani, PhD(Medical)

Role: STUDY_DIRECTOR

Clinical R&D, Zydus Research Center, Cadila Healthcare Limited, Moraiya, Ahmedabad-382213, Gujarat, India

Kevinkumar Kansagra, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical R&D, Zydus Research Center, Cadila Healthcare Limited, Moraiya, Ahmedabad-382213, Gujarat, India

Locations

Clinical R&D, Zydus Research Center, Cadila Healthcare Limited, NH No.8, Moraiya

Ahmedabad, Gujarat, India

Countries

India

Other Identifiers

CTRI/2011/12/002249

Identifier Type: OTHER

Identifier Source: secondary_id

ZYGK1/1001

Identifier Type: -

Identifier Source: org_study_id