Ignite Creation Date:
2024-07-17 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06467201
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-08
Brief Title:
SAD Study to Evaluate Safety Tolerability and Pharmacokinetic Profile of KSHN001126 in Healthy Post-Menopausal Females
Sponsor:
Shivanka Research LLC
Organization:
Shivanka Research LLC
Study Overview
Official Title:
An Open-label Sequential Dosing Single Ascending Dose SAD Study to Determine the Safety Tolerability and Pharmacokinetic Profile of KSHN001126 in Healthy Human Post-Menopausal Female Volunteers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 an Open-label Sequential dosing Single Ascending Dose SAD Study to Determine the Safety Tolerability and Pharmacokinetic PK Profile of KSHN001126 in Healthy Human Post-Menopausal Female Volunteers The primary objective of the study is to evaluate the safety and tolerability of increasing single doses of KSHN001126 while the secondary objective is to evaluate the plasma PK profile of KSHN001126 and its metabolites KSHN001167 KSHN001168 and Fulvestrant following ascending single oral doses of KSHN001126
Detailed Description:
None
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