Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06325930
Status:
COMPLETED
Last Update Posted:
2024-05-21
First Post:
2024-03-13
Brief Title:
A Study to Investigate the Absorption Metabolism and Excretion of 14C-HU6
Sponsor:
Rivus Pharmaceuticals Inc
Organization:
Rivus Pharmaceuticals Inc
Study Overview
Official Title:
An Open-Label Phase 1 Study in Healthy Adult Male Subjects to Investigate the Absorption Metabolism and Excretion of 14C-HU6 Following Single-Dose Oral Administration
Status:
COMPLETED
Status Verified Date:
2024-04
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 single-center non-randomized open-label Phase 1 study to characterize the absorption metabolism excretion mass balance pharmacokinetics PK safety and tolerability of HU6 following administration of a single dose of 14C-HU6 in a fed state with a standard meal administered approximately 15 minutes prior to dosing
Detailed Description:
This is a single-center non-randomized open-label Phase 1 study to characterize the absorption metabolism excretion mass balance pharmacokinetics PK safety and tolerability of HU6 following administration of a single dose of 14C-HU6 in a fed state with a standard meal administered approximately 15 minutes prior to dosing
Healthy adult males aged 18 to 55 inclusive who have provided written informed consent will be screened and subjects who meet all eligibility criteria may be enrolled into the study within 28 days of Screening
Approximately 8 eligible subjects will be admitted on Day -1 and baseline assessments will be completed On Day 1 8 subjects will receive a single dose of 14C-HU6 in a fed state If 85 mean of all subjects of the 14C label has been recovered in samples collected and analyzed through 336 hours after dosing and the mean of individual 14C recovery is 1 on each of 2 consecutive days all subjects will be discharged from the Pharmaron Clinical Pharmacology Center CPC on Day 15 after completion of all 336-hour timepoint assessments
Healthy adult males aged 18 to 55 inclusive who have provided written informed consent will be screened and subjects who meet all eligibility criteria may be enrolled into the study within 28 days of Screening
Approximately 8 eligible subjects will be admitted on Day -1 and baseline assessments will be completed On Day 1 8 subjects will receive a single dose of 14C-HU6 in a fed state If 85 mean of all subjects of the 14C label has been recovered in samples collected and analyzed through 336 hours after dosing and the mean of individual 14C recovery is 1 on each of 2 consecutive days all subjects will be discharged from the Pharmaron Clinical Pharmacology Center CPC on Day 15 after completion of all 336-hour timepoint assessments
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