AN EXPLORATORY PILOT STUDY FOR A TRPA1 TARGET ENGAGEMENT CHALLENGE WITH MUSTARD OIL AND CINNAMALDEHYDE

Completed

• Conditions: Peri-operative pain; peri-operative pain

• Registration Number: NL-OMON37172
• Lead Sponsor: PRA International EDS

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: 6

Inclusion Criteria

healthy male subjects
18-45 yrs, inclusive
BMI: 18.0-30.0 kg/m2, inclusive
non-smoking

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 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>MO challenge: size of the area of brush allodynia; pain intensity (NRS),<br /><br>cutaneous Doppler blood flow, area of flare response;<br /><br><br /><br>CMDH challenge: counting the number of coughs induced within 15 seconds after<br /><br>CMDH inhalation. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Safety: Adverse events (AE's).</p><br>