A clinical trial to study the safety and effects of new chemical molecule ADV-1002401 in Healthy, Adult Volunteers and Adult Type-II Diabetic Volunteers
- Registration Number
- CTRI/2010/091/000275
- Lead Sponsor
- Advinus Therapeutics Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 46
Part A:
Male subjects aged between 18 and 55 years (including both) with BMI between 18 to 25 kg/m2 (including both) with normal health as determined by personal medical history, clinical examination, 12 lead ECG, X-ray and laboratory examinations within the clinically acceptable normal range.
Part B:
Male diabetics aged between 18 and 60 years (including both) with BMI between 20 to 32 kg/m2 (including both).
Subjects with fasting blood glucose of 125 to 200 mg/dL while on current medication (metformin or sulfonylurea) / Drug naïve T2DM subjects with fasting plasma glucose of 125 to 200 mg/dL.
Subjects with HbA1c greater than or equal to 7.5%, and less than or equal to 10.5%.
Exclusion Criteria:
History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
History or presence of significant gastric and/or duodenal ulceration
History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumour
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability: Adverse events, vital signs measurements, electrocardiograms, physical examinations, clinical laboratory tests and continuous ECG monitoringTimepoint: Vital signs (sitting blood pressure and radial pulse rate) will be measured before dosing of investigational product (in the morning of the day of dosing) and at 1, 2, 4, 12, 24 and 48 h after dosing
- Secondary Outcome Measures
Name Time Method Pharmacokinetic and Pharmacdynemic Assessment<br>Timepoint: Post-dose blood samples of 2.0 mL each will be drawn at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 h following drug administration