Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT06657105
Status:
COMPLETED
Last Update Posted:
2025-02-07
First Post:
2024-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
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:
AstraZeneca
Organization:
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:
COMPLETED
Status Verified Date:
2025-02
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:
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:
False
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?: