Clinical trial NCT01472809: A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of Oral ZYGK1 in Healthy Volunteers
Official title: A Randomized, Double Blind Placebo Controlled Phase 1 Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ZYGK1, a Novel Glucokinase Activator, Following Oral Administration in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
Conditions: Diabetes
Keywords: ZYGK1
Cadila
Zydus
ZRC
Zydus Research Center
Phase 1
Diabetes
Lead sponsor: Zydus Lifesciences Limited
Sponsor class: INDUSTRY
First posted: 2011-11-17
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Safety and tolerability
timeFrame: Upto 14 Days
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: 7 Days
measure: Pharmacodynamics
timeFrame: 7 Days
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Clinical R&D, Zydus Research Center, Cadila Healthcare Limited, NH No.8, Moraiya
state: Gujarat
Study officials:
affiliation: Clinical R&D, Zydus Research Center, Cadila Healthcare Limited, Moraiya, Ahmedabad-382213, Gujarat, India
name: Rajendrakumar H Jani, PhD(Medical)
role: STUDY_DIRECTOR
affiliation: Clinical R&D, Zydus Research Center, Cadila Healthcare Limited, Moraiya, Ahmedabad-382213, Gujarat, India
name: Kevinkumar Kansagra, MD
role: PRINCIPAL_INVESTIGATOR
References: