Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06657105
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-23
Brief Title:
A Study to Investigate the Pharmacokinetics of Ethinyl Estradiol and Levonorgestrel When Given Alone and in Combination With Baxdrostat in Healthy Females of Non-childbearing Potential
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Fixed Sequence Study to Assess the Effect of Multiple Doses of Baxdrostat on the Pharmacokinetics of Single Doses of Combined Oral Ethinyl Estradiol and Levonorgestrel in Healthy Female Participants of Non-childbearing Potential
Status:
NOT_YET_RECRUITING
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:
The main purpose of the study is to assess the effect of multiple doses of baxdrostat on the pharmacokinetics PK of a single dose of combined oral ethinyl estradiol EE and levonorgestrel LNG Safety and tolerability of baxdrostat will be assessed during the study
Detailed Description:
This is an open-label 3-period fixed sequence study conducted at a single Clinical Unit
The study will comprise of
A Screening period of maximum 28 days
Period 1 - From Day -1 to Day 5
Period 2 -From Day 6 to Day 16
Period 3 - From Day 17 to Day 23
A Final Follow-up Visit 7 2 days after the last PK sample in Period 3
The study will comprise of
A Screening period of maximum 28 days
Period 1 - From Day -1 to Day 5
Period 2 -From Day 6 to Day 16
Period 3 - From Day 17 to Day 23
A Final Follow-up Visit 7 2 days after the last PK sample in Period 3
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