Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06644326
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
A PK Study of IkT-148009 in Older and Elderly Healthy Subjects
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Pharmacokinetic Bridging Study of Film-Coated Tablets of IkT-148009 in Older and Elderly Healthy Subjects
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 two-part study Part A consists of two different IkT-148009-201 solid dosage formulations that are being evaluated to determine their steady-state pharmacokinetic profile
Part B is a drug-drug interaction DDI study focused on evaluating the impact of a strong CYP3A inhibitor on the preferred dosage determined in part A
Part B is a drug-drug interaction DDI study focused on evaluating the impact of a strong CYP3A inhibitor on the preferred dosage determined in part A
Detailed Description:
This is a two-part study
Part A is a single dose 7-day study to determine the safety tolerability and pharmacokinetics PK of two different tablet formulations of IkT-148009 in older and elderly healthy subjects
Subjects in each cohort of the study will be admitted to the unit the day prior to the expected day of dosing and will be confined to the unit for approximately 12 days Each cohort will consist of six 6 subjects who will receive treatment with one of two formulations of IkT- 148009 film-coated tablets at a single dose once daily for 7 days
Part B is a Drug-Drug Interaction DDI study to determine the effect of itraconazole on the pharmacokinetics of IkT-148009
Subjects in each cohort of the study will be admitted to the unit the day prior to the expected day of dosing in each period and will be confined to the unit for approximately 6 days in period 1 and 10 days in period 2 Up to eight 8 subjects will be evaluated in a two-period design in the fed state
In Period 1 the 50 mg film-coated IkT-148009 tablet dose pharmacokinetics will be measured followed by a 7-day washout In Period 2 the same eight subjects will first be administered a 200 mg once daily capsule dose of itraconazole for four days On Period 2 day 4 subjects will take a single 200 mg capsule dose of itraconazole followed one hour later by a 50 mg film-coated tablet dose of IkT-148009
Part A is a single dose 7-day study to determine the safety tolerability and pharmacokinetics PK of two different tablet formulations of IkT-148009 in older and elderly healthy subjects
Subjects in each cohort of the study will be admitted to the unit the day prior to the expected day of dosing and will be confined to the unit for approximately 12 days Each cohort will consist of six 6 subjects who will receive treatment with one of two formulations of IkT- 148009 film-coated tablets at a single dose once daily for 7 days
Part B is a Drug-Drug Interaction DDI study to determine the effect of itraconazole on the pharmacokinetics of IkT-148009
Subjects in each cohort of the study will be admitted to the unit the day prior to the expected day of dosing in each period and will be confined to the unit for approximately 6 days in period 1 and 10 days in period 2 Up to eight 8 subjects will be evaluated in a two-period design in the fed state
In Period 1 the 50 mg film-coated IkT-148009 tablet dose pharmacokinetics will be measured followed by a 7-day washout In Period 2 the same eight subjects will first be administered a 200 mg once daily capsule dose of itraconazole for four days On Period 2 day 4 subjects will take a single 200 mg capsule dose of itraconazole followed one hour later by a 50 mg film-coated tablet dose of IkT-148009
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