Pharmacology Study of Sun Pharma Advanced Research Company Limited's S0597

Asthma Clinical Trial

Official title:

Study to Access Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Compound S0597 by Oral Inhalation: A Phase I/IIa Observer and Double Blind, Placebo and Active Controlled Parallel and Crossover Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02041221
• Other study ID #: SPARC_Ltd_ CLR_13_16
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: January 14, 2014
• Last updated: January 17, 2014
• Start date: January 2014
• Est. completion date: June 2015

Study information

• Verified date: January 2014
• Source: Sun Pharma Advanced Research Company Limited
• Contact: Arpeat Kaviya, MBChB MRCP
• Phone: 44 0 20 79107968
• Email: arpeat.kaviya[@]quintiles.com
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

Sun Pharma Advanced Research company Limited has developed a dry powder inhaler of compound S0597 for oral inhalation. This clinical study is a Phase I/IIa study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of S0597 administered by oral inhalation to healthy volunteers and asthma patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 82
• Est. completion date: June 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Subjects willing to provide informed consent

• Male or female subjects aged 18 to 65 years inclusive

• Body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive

• Non-smokers or ex-smokers

Exclusion Criteria:

• Subjects with a supine systolic blood pressure =160 mmHg and/or a supine diastolic blood pressure =100 mmHg

• Subjects who have a significant infection or known inflammatory process on screening or admission.

• Subjects who are unlikely to co-operate with the requirements of the study.

• Positive serology for infectious disease (hepatitisB or C , HIV) at screening

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• S0597
The subjects will receive S0597.
• Placebo

Locations

Country	Name	City	State
United Kingdom	Quintiles Drug Research Unit at Guy's Hospital, Quintiles Ltd.,	London	Great London

Sponsors (1)

Lead Sponsor	Collaborator
Sun Pharma Advanced Research Company Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events	The no of adverse events will be assessed to evaluate the safety and tolerability of compound SO597 in healthy male subjects and asthma patients	Two (2) Weeks	Yes
Primary	Number of subjects with adverse events	the no of subjects with adverse events will be assessed to evaluate the safety and tolerability of compound SO597 in healthy male subjects and asthma patients	Two (2) weeks	Yes
Primary	clinically significant changes in oral body temperature	clinically significant changes from baseline in oral body temperature will be assessed to evaluate the change in vital signs of compound SO597 in healthy male subjects and asthma patients	Two (2) Weeks	Yes
Primary	Clinically significant changes in pulse rate	Clinically significant changes from baseline in pulse rate will be assessed to evaluate the change in vital signs of compound SO597 in healthy male subjects and asthma patients	Two (2) Weeks	Yes
Primary	Clinically significant changes in respiratory rate	Clinically significant changes from baseline in respiratory rate will be assessed to evaluate the change in vital signs of compound SO597 in healthy male subjects and asthma patients	Two (2) Weeks	Yes
Secondary	Cmax	Cmax will be assessed to evaluate the pharmacokinetics of SO597 in healthy subjects and subjects with asthma.	Two (2) weeks	No
Secondary	AUC	AUC will be assessed to evaluate the pharmacokinetics of SO597 in healthy subjects and subjects with asthma.	Two (2) weeks	No
Secondary	Clinically significant change in serum cortisol levels	Clinically significant change in serum cortisol levels will be assessed to evaluate the pharmacodynamics of S0597 in healthy and subjects with mild asthma	Two (2) weeks	No
Secondary	Clinically significant change in FEV1	Clinically significant change in FEV1 will be assessed to evaluate the pharmacodynamics of S0597 in healthy and subjects with mild asthma	Two (2) weeks	No
Secondary	Clinically significant change in FeNo	Clinically significant change in FeNo will be assessed to evaluate the pharmacodynamics of S0597 in healthy and subjects with mild asthma	Two (2) weeks	No