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

A First in Human, Placebo-Controlled, Randomized, Double-Blind, Rising Single Dose Study of ADV-1002401 to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy, Adult Volunteers and Adult Type-II Diabetic Volunteers - Phase 01 Study

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000275

Enrollment

Registered

2010-03-19

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: ADV-1002401: 50, 200, 600, 1200 or 2000 mg Control Intervention1: Placebo: 50, 200, 600, 1200 or 2000 mg

Eligibility

Inclusion criteria

Inclusion criteria: 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 naÃ¯ve 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

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Pharmacokinetic and Pharmacdynemic Assessment 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	—

Countries

India

Contacts

Public ContactPrakash Patel

Sponsor Monitor

vikram.ramanathan@advinus.com08028394959

Outcome results