Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06641557
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
A Phase I 7-Day Dosing Study of IkT-148009
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase I 7-Day Dosing Study of 200 Mg IkT-148009 to Determine the Safety Tolerability and Pharmacokinetics PK of IkT-148009 in Older Adult and Elderly Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 1 study in older adult or elderly healthy volunteer subjects to measure the safety tolerability and pharmacokinetic PK profile of IkT-148009 capsules given as multiple capsules
Detailed Description:
This is a Phase 1 study in older adult or elderly healthy volunteer subjects to measure the safety tolerability and pharmacokinetic PK profile of IkT-148009 capsules given as multiple capsules
This is a single arm study with subjects to treatment with IkT-148009 only The study will consist of a total of up to 15 visits over a period of up to 29 days prior to dosing 7 days of dosing and 14 days of follow up
Subjects will receive a single daily dose of study drug with a meal for a period of up to 7 days A full breakfast must be consumed prior to receiving the dose study drug Subjects will be confined to the unit for approximately 12 days
This is a single arm study with subjects to treatment with IkT-148009 only The study will consist of a total of up to 15 visits over a period of up to 29 days prior to dosing 7 days of dosing and 14 days of follow up
Subjects will receive a single daily dose of study drug with a meal for a period of up to 7 days A full breakfast must be consumed prior to receiving the dose study drug Subjects will be confined to the unit for approximately 12 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None