A Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ZYD1, Following Subcutaneous Administration in Healthy Volunteers

NCT01972893 | Completed Phase 1 DMC

• 2 other identifiers: ZYD1/1001CTRI/2011/04/001684
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

ZYD1 is a novel GLP-1 receptor agonist. The ZYD1 exhibits increased stability to proteolytic cleavage, especially against dipeptidyl peptidase-4 (DPP-IV). ZYD1 is a potent antidiabetic agent without gastrointestinal side-effects. A first in human (FIH) Phase I study intends to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ZYD1 in normal healthy adult volunteers.

Conditions

Type 2 Diabetes Mellitus

Keywords

Selective GLP-1 agonist

Outcome Measures

Primary Outcomes (1)

• To evaluate Safety and tolerability of ZYD1

  The safety and tolerability shall be evaluated using physical examinations, standard laboratory tests (hematology, biochemistry and urine examination), and electrocardiogram (ECG). Spontaneously reported and solicited adverse events will also be used for safety parameters.

  21 days

Secondary Outcomes (1)

• Pharmacokinetics (PK) and Pharmacodynamic (PD) effect after single and multiple subcutaneous dose administrations in healthy adult male volunteers Gender effect study.

  1. For Plan I and III - Pre-dose (before dosing), 0.5, 1, 2, 3, 4, 6 ,8, 10, 12, 24, 48, 72 and 120 hrs post dose 2. Plan II - Day 01 - Pre-dose, 1, 2, 3, 4 and 8 hours following first dosing. Day 02 to 06 - Pre-dose of each . Day 07 - Pre-dose, 1, 2, 3,

Study Arms (2)

ZYD1

EXPERIMENTAL

Tablet ZYD1 5 to 50 mg subcutaneously Once a day (OD) or BID depending upon the pharmacokinetic profile obtained in Plan I (Single dose study)

Drug: ZYD1

Placebo

PLACEBO COMPARATOR

Tablet Placebo 5 to 50 mg subcutaneously OD or BID depending upon the pharmacokinetic profile obtained in Plan I (Single dose study)

Drug: Placebo

Interventions

ZYD1 DRUG

Plan I - Tablet ZYD1 - 0.5, 1 , 2, 5, 10, 25 and 50 mg subcutaneously OD after overnight fasting. Plan II - Tablet ZYD1 - 0.5, 1 , 2, 5, 10 and 25 mg subcutaneously OD after overnight fasting. Plan III - Tablet ZYD1 2/5 mg subcutaneously OD after overnight fasting depending on results of Plan I.

Also known as: Selective GLP-1 agonist

ZYD1

Placebo DRUG

Plan I - Tablet Placebo - 0.5, 1 , 2, 5, 10, 25 and 50 mg subcutaneously OD after overnight fasting. Plan II - Tablet Placebo - 0.5, 1 , 2, 5, 10 and 25 mg subcutaneously OD after overnight fasting. Plan III - Tablet Placebo 2/5 mg subcutaneously OD after overnight fasting depending on results of Plan I.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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 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 1 year menopause or use of long acting nonhormonal contraceptive measures (e.g., intrauterine device) will be recruited.

You may not qualify if:

• Presence or history of hypersensitivity to any of the active or inactive ingredients of ZYD1 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 above the upper limit of the reference range)
• Active liver disease and/or liver transaminases greater than 1.5 X UNL
• Subject with personal or family history of medullary thyroid cancer
• Subject with personal or family history of multiple endocrine neoplasia syndrome type 2
• Subject with serum calcitonin \>50 ng/L
• 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) tests on the day of check in
• History or presence of any medication in the last 14 days including any medication known to interact with the Cytochrome P (CYP) 450 system
• 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

Sponsors & Collaborators

• Zydus Lifesciences Limited: lead

Study Sites (1)

Zydus Research Centre, Survey No. 396/403, Opp. Sarvotam Hotel, Nr. Nova Petrochemicals, Sarkhej-Bavla N.H. No. 8A, Village : Moraiya,

Ahmedabad, Gujarat, 382213, India

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Rajendrakumar H Jani, PhD(Medical)

  Senior Vice President - Cadila Healthcare Limited

  STUDY DIRECTOR

• Kevinkumar Kansagra, MD

  Zydus Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 5, 2012
• First Posted: October 31, 2013
• Study Start: February 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: June 1, 2012
• Last Updated: October 31, 2013

Record last verified: 2013-10

Locations

IN (1)