Ignite Creation Date:
2024-10-25 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06556745
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-14
Brief Title:
Pharmacokinetics of Butyrate Tablet BKR-017
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Study of Safety and Pharmacokinetics of BKR-017 in Individuals on Statin Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
The purpose of this study is to evaluate the pharmacokinetic profile and systemic exposure of BKR-017 in individuals on statin therapy after a single dose and at steady state after seven days repeated twice daily dosing
Detailed Description:
BioKier will conduct an open-label study to evaluate the safety and PK profile of BKR-017 in ten hypercholesterolemic 100 mgdL statin-treated subjects to reflect the target population aged 18-70 after a single dose and at steady-state after seven days repeat dosing Figure 4 On the morning of Study Day 0 subjects will take three tablets 15 g of BKR-017 followed by breakfast Blood samples will be taken for PK analysis at -1 -025 05 1 2 4 6 8 10 12 and 24 hours after dosing After an overnight stay in the clinic the 24-hour PK sample will be taken and subjects will be provided with one weeks supply of BKR-017 tablets and a diary for keeping track of tablets taken instructed to take three 500-mg tablets 15 g BID and released from the clinic On Study Day 8 subjects will return to the clinic and Study Day 0 procedures will be repeated after dose-compliance is confirmed PK samples will be analyzed by Southern Research using the butyric acid ELISA kit provided by Biomatik EKU08762 All regulations will be met according to FDA regulations governing human subject protection and the conduct of clinical trials
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