Ignite Creation Date:
2024-05-06 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05042986
Status:
COMPLETED
Last Update Posted:
2022-04-20
First Post:
2021-09-03
Brief Title:
A Study of the Absorption Metabolism and Excretion of 14C-SKI-O-703 Following a Single Oral Dose in Healthy Male Subjects
Sponsor:
Oscotec Inc
Organization:
Oscotec Inc
Study Overview
Official Title:
A Phase I Open-label Study of the Absorption Metabolism and Excretion of 14C-SKI-O-703 Following a Single Oral Dose in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2022-04
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 will be a Phase I open-label nonrandomized single dose study in healthy male subjects
Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the dose administration Subjects will be admitted into the study site on Day -1 and be confined to the study site until at least Day 8 On the morning of Day 1 all subjects will receive a single oral dose of 14C-SKI-O-703 Subjects will be discharged if the following discharge criteria are met plasma radioactivity levels below the limit of quantitation for 2 consecutive collections 90 mass balance recovery and 1 of the total radioactive dose is recovered in combined excreta urine and feces in 2 consecutive 24-hour periods If discharge criteria are not met by Day 8 subjects will remain in the study site up to Day 15
Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the dose administration Subjects will be admitted into the study site on Day -1 and be confined to the study site until at least Day 8 On the morning of Day 1 all subjects will receive a single oral dose of 14C-SKI-O-703 Subjects will be discharged if the following discharge criteria are met plasma radioactivity levels below the limit of quantitation for 2 consecutive collections 90 mass balance recovery and 1 of the total radioactive dose is recovered in combined excreta urine and feces in 2 consecutive 24-hour periods If discharge criteria are not met by Day 8 subjects will remain in the study site up to Day 15
Detailed Description:
SKI-O-703 is being developed by Oscotec Inc and is currently being studied for the treatment of adult patients with moderately to severely active rheumatoid arthritis and for the treatment of patients with persistent and chronic immune thrombocytopenia SKI-O-592 the free base of SKI-O-703 has demonstrated high selectivity and potency against spleen tyrosine kinase in a biochemical assay For immunoreceptor activation linked to SYK the effect of SKI-O-592 on the anti-inflammatory response consisting of tumor necrosis factor alpha β-hexosaminidase and CD69 expression was greater than the effects of first-generation SYK inhibitors eg R406 in several immune cell lines and in human primary cells This anti-inflammatory activity was responsible for the selective inhibition of p-SYK Y525526 which led to the sequential inhibition of downstream effectors In vitro studies revealed excellent SYK selectivity of SKI-O-592 that led to no inhibition of SYK-independent signal pathways indicating that SKI-O-592 shows more potent anti-inflammatory activity to allow continuous administration of SKI-O-703 compared with the first-generation SYK inhibitors SKI-O-703 is currently not approved or marketed in any country
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