A phase I study to investigate the pharmacokinetics, safety and tolerability of four different dosing regimens of GRC 17536 in healthy male volunteers using tablet formulation.

Completed

• Conditions: Pijn en luchtwegaandoeningen; Pain and respiratory conditions

• Registration Number: NL-OMON42613
• Lead Sponsor: Glenmark Pharmaceuticals SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 28

Inclusion Criteria

healthy male subjects
18 - 45 years of age, inclusive
BMI 18.0 - 28.0 kilograms/meter2, inclusive
weight at least 50 kilograms

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>To assess the pharmacokinetics of GRC 17536 following multiple oral<br /><br>administration of tablet formulations at four different dose levels: (a) two<br /><br>tablets of 90 mg GRC 17536 twice daily (i.e., 360 mg daily dose), (b) three<br /><br>tablets of 90 mg GRC 17536 twice daily (i.e., 540 mg daily dose), (c) four<br /><br>tablets of 90 mg GRC 17536 twice daily (i.e., 720 mg daily dose), and (d) three<br /><br>tablets of 45 mg twice daily (i.e., 270 mg daily<br /><br>dose) administered in normal healthy adult male subjects.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To evaluate the safety and tolerability of GRC 17536 in normal healthy adult<br /><br>male subjects following multiple oral administration of the tablet<br /><br>formulations.</p><br>