NCT01472809

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.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
96

participants targeted

Target at P75+ for phase_1 diabetes

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 17, 2011

Completed
14 days until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Last Updated

November 24, 2015

Status Verified

November 1, 2015

Enrollment Period

1 year

First QC Date

November 9, 2011

Last Update Submit

November 20, 2015

Conditions

Diabetes

Keywords

ZYGK1CadilaZydusZRCZydus Research CenterPhase 1Diabetes

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability

    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.

    Upto 14 Days

Secondary Outcomes (2)

  • Pharmacokinetics

    7 Days

  • Pharmacodynamics

    7 Days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo tablets

Drug: Placebo

ZYGK1

EXPERIMENTAL

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

Drug: ZYGK1

Interventions

ZYGK1DRUG

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

ZYGK1
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 18-45 years
  • Mentally, physically, and legally eligible to give informed consent
  • Male and female volunteers weighing between 50-75 kg and 45-75 kg (4) respectively.
  • Ability to communicate effectively with the study personnel
  • Willingness to adhere to the protocol requirements
  • 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.
  • 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

You may not qualify if:

  • Presence or history of hypersensitivity to any of the active or inactive ingredients of ZYGK1 formulation
  • Presence or history of pancreatitis at any time (Serum Amylase/Serum Lipase more than upper normal limit (UNL))
  • Presence or history of severe gastrointestinal disease in the last 6 months
  • Presence or history of renal insufficiency at any time (serum creatinine \>UNL)
  • Active liver disease and/or liver transaminases greater than 1.5 X UNL
  • 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)
  • Abnormal bleeding time (BT), clotting time (CT), prothrombin time (PT), and activated partial prothrombin time (APTT)
  • History or presence of any medication in the last 14 days
  • History or presence of significant alcoholism or drug abuse within the past 1 year
  • History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco products (more than 10 times per day)
  • Difficulty with donating blood
  • 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
  • Pulse rate less than 60 minute and more than 100/minute
  • Any clinically significant laboratory findings during screening
  • History or presence of any clinically significant electrocardiogram (ECG) abnormalities during screening
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Ahmedabad, Gujarat, 382213, India

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Rajendrakumar H Jani, PhD(Medical)

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

    STUDY DIRECTOR

  • Kevinkumar Kansagra, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2011

First Posted

November 17, 2011

Study Start

December 1, 2011

Primary Completion

December 1, 2012

Last Updated

November 24, 2015

Record last verified: 2015-11

Locations

IN(1)