PHARMACOKINETICS AND METABOLISM OF 14C-LABELED GRC 4039 SODIUM FOLLOWING A SINGLE ORAL ADMINISTRATION IN HEALTHY MALE VOLUNTEERS

Completed

• Conditions: chronische ontstekingsziekten; chronic inflammatory disorders

• Registration Number: NL-OMON37911
• Lead Sponsor: Glenmark Pharmaceuticals SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

healthy male subjects
18-55 yrs, inclusive
BMI: 18.5-29.5 kg/m2, inclusive
Weight: 55-95 kg, 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>Pharmacokinetics: Pharmacokinetic parameters, based on the plasma and urine<br /><br>concentrations of total radioactivity, parent GRC 4039 and metabolite GRC 4037,<br /><br>the fecal radioactivity concentrations and metabolite profiling<br /><br><br /><br>Safety: AEs, vital signs, 12-lead ECG; clinical laboratory, physical<br /><br>examination</p><br>

Secondary Outcome Measures

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