None listed
Conditions
Interventions
Intervention1: Placebo: prospective, randomized, double blind
Intervention2: ZYG19: 1. Route of administration: Oral 2. Frequency: Plan I: ZYG19 shall be administered a single oral dose in the overnig
Sponsors
Zydus Research Centre
Eligibility
Inclusion criteria
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 6.In case if Type 2 diabetic subjects are invited for the study: •Their HbA1c should be >= 7% and •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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerabilityTimepoint: Safety and tolerability Plans I,II and III[upto Day 8] Plan IV [ upto Day 21 ] | — |
Secondary
| Measure | Time frame |
|---|---|
| PK, PD & Relationships between drug exposures and PD parameters either with or without OGTTTimepoint: PK: 1.Blood â?¢Plans I, II, III:[Time frame: pre dose to 168 hrs] â?¢Plan IV: [Pre-dose to 168 hrs post dose on Day 14] 2. Urine: â?¢Plans I, II, III: [Time frame: pre dose to 36-48 hrs post dose on Day 3] â?¢Plan IV: [Pre-dose to 36-48 hrs of first dose on Day 14] PD: Plasma glucose, GLP-1, Serum insulin- peptide â?¢PlansI, II,III:[Time frame: 24.5 hrs pre dose-Day 0 up to 4 hours after dosing on Day 01] â?¢Plan IV [Time frame: 24.5hrs pre dose-Day 0 upto 4hours after dosing on Day 14] | — |
Countries
India
Contacts
Public ContactDr R H Jani
Zydus Research Centre
Outcome results
None listed