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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cadila Healthcare Limited
ClinicalTrials.gov Identifier:
NCT01472809
First received: November 9, 2011
Last updated: January 29, 2014
Last verified: January 2014

November 9, 2011
January 29, 2014
December 2011
January 2014   (final data collection date for primary outcome measure)
Safety and tolerability [ Time Frame: Upto 14 Days ] [ Designated as safety issue: Yes ]

Safety and tolerability for-

  • Plan I, Plan III and Plan IV [Time frame: up to Day 8]
  • Plan II [Time frame: upto Day 14]

Frequency of adverse events will be assessed at each dose level.

Same as current
Complete list of historical versions of study NCT01472809 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics [ Time Frame: 7 Days ] [ Designated as safety issue: No ]

    Pharmacokinetics after oral administration of ZYGK1 in

    • Plan I, III and IV: [Time frame: 0.25 - 168 hrs post drug administration]
    • Plan II: [Time frame:Day 1: 0.25 - 12 hours, Day 2-6: 0, 2, 4 Hours, Day: 0.25-168 hours post drug administration]

    Effects of food on the pharmacokinetics will be assessed in healthy subjects.

  • Pharmacodynamics [ Time Frame: 7 Days ] [ Designated as safety issue: No ]

    Plasma glucose, serum insulin, C-peptide and glucagoan estimate -

    • Plane I and Plan III [Time frame: Day 0 and Day 1: upto 4 hours post oral glucose 75 grams]
    • Plan II [Time frame: Day 0, Day 1 and Day 7: upto 4 hours post oral glucose 75 grams]
    • Plan IV: [Time frame: Period 2: Day 0 and Day 1: upto 4 hours post meal]
Same as current
Not Provided
Not Provided
 
A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of Oral ZYGK1 in Healthy Volunteers
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

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes
  • Drug: 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

    Other Name: ZYGK1
  • Drug: Placebo
    Placebo Tablets: 0.125, 0.25, 0.5, 1, 2, ... mg
    Other Name: Placebo
  • Placebo Comparator: Placebo
    Placebo tablets
    Intervention: Drug: Placebo
  • Experimental: 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: Drug: ZYGK1
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
96
April 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01472809
ZYGK1/1001, CTRI/2011/12/002249
Yes
Cadila Healthcare Limited
Cadila Healthcare Limited
Not Provided
Study Director: Rajendrakumar H Jani, PhD(Medical) Clinical R&D, Zydus Research Center, Cadila Healthcare Limited, Moraiya, Ahmedabad-382213, Gujarat, India
Principal Investigator: Kevinkumar Kansagra, MD Clinical R&D, Zydus Research Center, Cadila Healthcare Limited, Moraiya, Ahmedabad-382213, Gujarat, India
Cadila Healthcare Limited
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP