A clinical study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of S0597 by intranasal route in healthy male subjects

A randomized, double-blind, placebo-controlled, parallel-groups, intranasal dose escalating study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of compound S0597 by intranasal route in healthy male subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001413

Enrollment

Registered

2010-10-05

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: S0597: single dose Control Intervention1: Placebo: single dose

Eligibility

Inclusion criteria

Inclusion criteria: • Availability of subject for the entire study period and willingness to adhere to protocol requirements. • 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). • Morning basal serum cortisol value within the normal range of 8 to 25 mcg/dL, inclusive. • 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. • Subjects whose screening laboratory values are within normal limits or considered by the Principal Investigator/Sub-Investigator to be of no clinical significance. • Subjects, who are able to demonstrate that they are able to perform the dosing technique properly after training and evaluation on use of the nasal spray by using a placebo spray bottle. • Informed consent form given in written form

Exclusion criteria

Exclusion criteria: 1. FEV1 &#8804;80% of predicted normal value 2. History or presence of significant: 2.1 Difficulty in taking intranasal spray. 2.2 Ear-nose-throat disease, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease. 2.3 Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within past one year. 2.4 Smoking (more than or equal to 10 cigarettes/day) or consumption of tobacco products (> 4 chews/day). 2.5 Positive result to HIV, HBsAg, HCV, or VDRL/RPR. 2.6 Use of enzyme-modifying drugs (like Phenytoin, Carbamazepine, Barbiturates, Gresiofulvine etc.) in the previous 30 days before day 1 of this study. 3. Donation of 350 ml or more of blood in the previous 90 days before day 1 of this study. 4. Participation in another clinical study within the preceding 90 days of study starts. 5. Subjects who have: 5.1 Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg 5.2 Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations (2-4mm Hg) at check-in may be acceptable at the discretion of the clinical investigator. 5.3 Pulse rate below 60/min. or above 100/min.

Design outcomes

Primary

Measure	Time frame
Adverse events, vital signs, clinical laboratory tests, ECG, Anterior rhinoscopyTimepoint: Screening, check-in, in-study, check-out, post-study	—

Secondary

Measure	Time frame
Pharmacokinetic parametersTimepoint: In-study	—

Countries

India

Contacts

Public ContactDr Mudgal Kothekar MD

Sun Pharma Advanced Research Company Limited

Clinical.Trials@sparcmail.com912266455645

Outcome results