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

Zydus Lifesciences

Status and phase: Suspended; Phase 1

Conditions: Diabetes

Treatments: Drug: Placebo; Drug: ZYGK1

Study type: Interventional

Funder types: Industry

Identifiers

NCT01472809

CTRI/2011/12/002249 (Other Identifier)

ZYGK1/1001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

96 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo tablets

Treatment:

Drug: Placebo

ZYGK1

Experimental group

Description:

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

Treatment:

Drug: ZYGK1