None listed
Conditions
Interventions
Intervention1: CPL-2009-0031: Cohort (Dose-level) -I: CPL-2009-0031 (35mg) and its matching placebo
Cohort (Dose-level) â??II: CPL-2009-0031 (70mg) and its matching placebo
Cohort (Dose-level) â??III
Sponsors
Cadila Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Stage I ï?§ Subject willing to comply with the protocol and has signed ethics committee approved informed consent form (ICF). ï?§ Healthy adult male within age group of 18-55 years ï?§ BMI in the range of 18.5 â?? 24.9 kg/m2 ï?§ No hypersensitivity or contraindication to DPP-IV inhibitors or excipients of investigational drug formulation ï?§ Free of any acute/chronic illness ï?§ Subjects who are in good health at the time of entry into the study as determined by medical, medication and hypersensitivity histories, clinical examination, vital sign measurements, chest X-ray, 12-lead ECG measurement and clinical judgment of the investigator. ï?§ Documented negative test for human immuno virus (HIV-1/2), Hepatitis B surface antigen (HBsAg) and Hepatitis C virus (HCV). ï?§ Sexually active male subject with partners of childbearing potential must practice acceptable barrier contraception during the treatment and at least 2 months after the last dose to prevent his partner from becoming pregnant during the study.
Exclusion criteria
Exclusion criteria: ï?§ History or currently consuming drugs of abuse or alcohol. ï?§ Subjects who has received any drug other than OTC product within 30 days of dosing or any OTC product 7 days prior to dosing ï?§ Participation in another clinical trial in the past 3 months. ï?§ Subject with an abnormal clinical chemistry, hematology or urinalysis results that is considered clinically significant by the investigator or the sponsor. ï?§ Subjects with history of smoking or currently having smoking habit will not be included in the study. ï?§ History of hypotensive episodes, or systolic blood pressure reading of 139 mm Hg or a diastolic reading >89 mm Hg at time of general physical examination. ï?§ Xanthine-containing food or beverages (tea, coffee, chocolates, soft drinks like cola etc.) within 24 hours prior to the dosing of each period or alcoholic products consumption within 48 hours prior to the dosing of each period. ï?§ Subjects otherwise judged by the investigators or sub-investigator to be inappropriate for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stage I : To evaluate safety and tolerability of CPL-2009-0031 at its single-escalating doses, by observing: 1. Frequency of Serious adverse events 2. Number and severity of hypoglycemic events Timepoint: Safety will be observed till 7 days post-dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Stage I: To determine safety, tolerability and pharmacokinetics of CPL-2009-0031 at its single-escalating dose. Frequency and severity of adverse events Number and severity of clinically significant laboratory values Pharmacokinetic parameters: Cmax, AUC0-t, AUC0-inf, Tmax, t1/2, Kel, Vd, CL/FTimepoint: Adverse events will be observed till 7 days post-dose. Laboratory investigations will be performed at screening and day 7. Pharmacokinetic parameters: Blood sampling for PK assessment will be done at pre-dose (0.00 Hr) and at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0, 24.0,48.0,72.0 Hr post-dose. | — |
Countries
India
Contacts
Public ContactDr Akhil Sanghal
Cadila Pharmaceuticals Limited
Outcome results
None listed