Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05730842
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2023-02-07
Brief Title:
Absorption Metabolism Excretion and Absolute Bioavailability of EDG-5506 in Healthy Volunteers
Sponsor:
Edgewise Therapeutics Inc
Organization:
Edgewise Therapeutics Inc
Study Overview
Official Title:
A Phase 1 Open-label Study in Healthy Male Subjects of the Absorption Metabolism Excretion and Pharmacokinetics of EDG-5506 and an Absolute Bioavailability Study Using Radiolabeled EDG-5506
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 1 2-part single-center open-label study in healthy male volunteers Part A will assess the absorption metabolism excretion and pharmacokinetics of one oral dose of radiolabeled EDG-5506 Part B will assess bioavailability of EDG-5506 with a single oral dose of EDG-5506 and a single intravenous dose of radiolabeled EDG-5506
Detailed Description:
This is a Phase 1 2-part single-center open-label study
Up to 15 8 in Part A and 7 in Part B healthy male subjects will be enrolled in the study
Part A
Potential subjects will be screened to assess eligibility within 28 days prior to dose administration Subjects will be admitted on Day -1 and confined to the study site until at least Day 30 On Day 1 subjects will receive a single oral suspension Blood urine and feces samples will be collected for determination of EDG-5506 concentration total radioactivity and metabolite profiling and identification Between Day 30 and Day 36 subjects will be discharged
Part B
Potential subjects will be screened to assess their eligibility within 42 days prior to dose administration Subjects will be admitted on Day -1 and confined to the study site until Day 8 On Day 1 subjects will receive a single oral dose of EDG-5506 in the fasted state followed 2 hours later by a single dose of radiolabeled EDG-5506 Subjects will be discharged from the study site on Day 8 Blood samples will be collected
Up to 15 8 in Part A and 7 in Part B healthy male subjects will be enrolled in the study
Part A
Potential subjects will be screened to assess eligibility within 28 days prior to dose administration Subjects will be admitted on Day -1 and confined to the study site until at least Day 30 On Day 1 subjects will receive a single oral suspension Blood urine and feces samples will be collected for determination of EDG-5506 concentration total radioactivity and metabolite profiling and identification Between Day 30 and Day 36 subjects will be discharged
Part B
Potential subjects will be screened to assess their eligibility within 42 days prior to dose administration Subjects will be admitted on Day -1 and confined to the study site until Day 8 On Day 1 subjects will receive a single oral dose of EDG-5506 in the fasted state followed 2 hours later by a single dose of radiolabeled EDG-5506 Subjects will be discharged from the study site on Day 8 Blood samples will be collected
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None