A PHASE I, SINGLE CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, SINGLE DOSE STUDY IN HEALTHY FEMALE AND ELDERLY VOLUNTEERS AND MULTIPLE ASCENDING DOSE STUDY IN HEALTHY MALE AND FEMALE VOLUNTEERS BETWEEN THE AGES OF 18-80 YEARS TO INVESTIGATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF GRC 17536

Completed

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

• Registration Number: NL-OMON38062
• 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: 74

Inclusion Criteria

Part 1: healthy females, 18 - 45 and 46 - 65 years of age, BMI 18.0 - 30.0 kg/m2, no smokers
Part 2: healthy elderly males and females, 65 - 80 years of age, BMI 18.0 - 30.0 kg/m2, no smokers
Part 3: healthy young and elderly males, 18 - 45 and 65 - 80 years of age, and healthy young and elderly females, 18 - 45 years of age and 65 - 80 years of age, BMI 18.0 - 30.0 kg/m2, no smokers
Part 4: healthy males, 18 - 45 years of age, BMI 18.0 - 30.0 kg/m2, no smokers;18 - 80 years of age, male and female, BMI 18.0 - 30.0 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 60 days from the start of the study. In case of have taken part in more than 3 other drug studies (for men) or more than 2 other drug studies (for women) in the 10 months prior to the start of this study, or when having donated more than 1.5 liters of blood (for men) or more than 1.0 liters of blood (for women) in the 10 months prior to 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 (Part 1 - 3), concentration of GRC<br /><br>17356 in Cerebrospinal Fluid (liquor)(Part 4)<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<br /><br>blood pressure, pulse rate, respiratory rate, oral body temperature),<br /><br>continuous cardiac monitoring (Part 2 and 3 in<br /><br>volunteers *65 yrs), physical examination.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n/a</p><br>