A clinical study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered ZYG19 in volunteers.

Phase 1

Completed

• Registration Number: CTRI/2011/12/002238
• Lead Sponsor: Zydus Research Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 96

Inclusion Criteria

1.Healthy male or female between 18 and 65 years of age. A female subject is eligible to participate, if she has no-childbearing potential (e.g., postmenopausal or post-hysterectomy).

2.Male subjects must agree to use one of the contraception methods during the study.

3.BMI within the range 20 - 29.9 kg/m2

4.Capable of giving written informed consent, which includes compliance with protocol.

5.QTcB or QTcF < 450msec.

6.In case if Type 2 diabetic subjects are invited for the study:

•Their HbA1c should be >= 7% and <= 9% at screening

•They should meet ADA criteria (Annexure VII) and a history of either not having any therapy for last 03 months or history of stabilization on one of the following for 03 months:-

ï?¼Metformin

ï?¼GLP-1 agonist (e.g. Exenatide etc..)

ï?¼DPP IV inhibitors ( Sitagliptin, Vildagliptin etc..)

Exclusion Criteria

1.History of drug and/or alcohol abuse

2.Body Mass Index (BMI): less than 20 or more than 29.9 kg/m2

3.Presence or history of any of the following disorders/disease within the past 3 months, that might have impact on the clinical trial as judged by the investigator-

a)cardiovascular,

b)cerebrovascular,

c)dermatological,

d)gastrointestinal,

e)gynecological

f)hematological,

g)hepatic,

h)malignancy,

i)metabolic,

j)musculoskeletal,

k)neurological,

l)psychiatric,

m)renal,

n)respiratory,

o)venereal,

p)any other major disorders.

4.Uncontrolled hypertension (systolic blood pressure more than 150 mm Hg and/or diastolic blood pressure more than 90 mm Hg).

5.History of stomach/gastric surgery, inflammatory bowel disease.

6.Presence or history of pancreatitis, pancreatectomy.

7.Surgery within last 4 weeks or planned major surgery within next 3 months from the date of screening.

8.Participation in a life style modification program within the prior 8 weeks.

9.Weight loss more than 4.5 kg in the 3 months prior to screening visit or use of weight loss medications (prescription or OTC) within 30 days of screening.

10.Allergic reaction to any GLP-1 agonist in the past (e.g. exenatide) or to metacresol

Additional exclusion criteria for diabetic subjects:

1.Any history of type 1 diabetes or diabetic ketoacidosis.

2.History of outpatient insulin use within last 1 year (insulin use while hospitalized is acceptable).

3.Use of medications which are likely to affect blood glucose levels such as hypoglycemic agents, insulin sensitizers over past 7 days.

4.History of impaired hepatic function (AST and/or ALT levels more than or equal to 1.5X UNL) and impaired renal function (estimated Creatinine clearance less than 60 ml/min or S. Creatinine more than 1.5mg/dl).

Study & Design

• Study Type: Interventional
• Study Design: Not specified