None listed
Conditions
Interventions
Intervention1: S0597: Single oral dose of S0597, 0.35 mg, given once.
Intervention2: S0597: Single oral dose of S0597, 0.7 mg, given once.
Intervention3: S0597: Single oral dose of S0597, 1.4 mg, give
in a cohort of 8 subjects at the 11.2 mg dose level, 6 subjects will
receive S0597 and 2 subjects will receive placebo.
Sponsors
Sun Pharma Advanced Research Company Limited
Eligibility
Inclusion criteria
Inclusion criteria: Subjects meeting all of the following criteria will be considered for enrolment in the study: 1. Availability of subject for the entire study period and willingness to adhere to protocol requirements. 2. Healthy male subjects, 18 through 45 years of age, subjects having weight at least 50Kg and the subjectâ??s body mass index (BMI) must be within 18.5 â?? 25.0 (Kg/m2) (inclusive). 3. Morning basal serum cortisol value within the normal range of 8 to 25 mcg/dL,inclusive. 4. Subjects who have no evidence of underlying disease during screening medical history and whose physical examination is performed within 21days prior to commencement of the study. 5. Subjects whose screening laboratory values are within normal limits or considered by the Principal Investigator/Sub-Investigator to be of no clinical significance. 6. Informed consent form given in written form
Exclusion criteria
Exclusion criteria: 1. History or presence of significant: 1.1 Difficulty in swallowing. 1.2 Ear-nose-throat disease, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease. 1.3 Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within past one year. 1.4 Smoking (³ 10 cigarettes/day) or consumption of tobacco products ( 4 chews/day). 1.5 History of difficulty in coming for follow up. 1.6 Clinically significant illness within 4 weeks before the start of the study 1.7 Subjects who have been on an abnormal diet (for whatever the reason) during the four weeks preceding the study 1.8 Positive result to HIV, HBsAg, HCV, or RPR. 1.9 Use of enzyme-modifying drugs (like Phenytoin, Carbamazepine, barbiturates, Gresiofulvin etc.) or drugs of similar category to the investigational product (steroids) in the previous 30 days before day 1 of this study. 1.10 Abnormal 12 lead ECG, chest X-ray, MRI of neck and brain for thymus and pituitary. 2. Donation of 350 ml or more of blood in the previous 90 days before day 1 of this study. 3. Participation in another clinical study within the preceding 90 days of study starts. 4. Subjects who have: 4.1 Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg 4.2 Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations (2-4 mm Hg) at check-in may be acceptable at the discretion of the clinical investigator. 4.3 Pulse rate below 60/min. or above 100/min.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safetyTimepoint: Adverse events will be monitored continuously throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamics (Effect on HPA axis [serum cortisol])Timepoint: 24-hour serum cortisol profiles will be determined from a total of 13 blood samples collected at 2-hour intervals on the day before the dosing (i.e., baseline: Day â??1, starting 24 hours before dosing), and 12 blood samples collected at 2-hour intervals after dosing, at the same time-points in a 24-hour clock.;Pharmacodynamics (Effect on HPA axis [urine cortisol])Timepoint: On Day -1, subject will urinate into the toilet on getting up in the morning. Afterwards, all urine will be collected in a special container for the next 24 hours. On Day 1, subject will urinate into the container when they get up in the morning. This will constitute pre-dose 24-hr urine sample.;PharmacokineticsTimepoint: pre-dose, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 10,12, 16, 20 and 24 hours post dose | — |
Countries
India
Contacts
Public ContactDr Mudgal Kothekar MD
Sun Pharma Advanced Research Company Ltd
Outcome results
None listed