A phase I, single center, randomized, double blind, placebo controlled, single ascending dose study to investigate the safety, tolerability, and pharmacokinetics of GRC 17536, a new TRPA1 antagonist, in healthy volunteers.

Completed

• Conditions: Astma, COPD, hoesten, chronische pijn; Asthma; COPD

• Registration Number: NL-OMON36129
• Lead Sponsor: Glenmark Pharmaceuticals SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 76

Inclusion Criteria

18 - 45 years of age, male, BMI 18.0 - 28.0 kg/m2, no smokers.

Exclusion Criteria

Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 90 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacokinetics:<br /><br>Plasma and urine PK parameters for GRC17536<br /><br><br /><br>Safety :<br /><br>AEs, haematology, serum biochemistry, urinalysis, 12-lead ECGs, vital signs<br /><br>(supine and standing systolic and diastolic blood pressure, pulse rate,<br /><br>respiratory rate, oral body temperature), continuous cardiac monitoring (Part 4<br /><br>and 6a in volunteers *65 yrs), physical examination.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable.</p><br>