Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
Study NCT ID:
NCT06250205
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2024-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluate the Pharmacokinetics of a Combined Oral Contraceptive (COC) With and Without Obicetrapib
Sponsor:
NewAmsterdam Pharma
Organization:
Study Overview
Official Title:
A Study to Evaluate the Effect of Daily Doses of Obicetrapib Tablets on the Pharmacokinetics of Drospirenone and Ethinyl Estradiol in Healthy Adult Female Subjects
Status:
COMPLETED
Status Verified Date:
2024-09
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:
A study to evaluate the impact of Obicetrapib on the PK levels of Drospirenone and Ethinyl Estradiol (COC) in 30 adult female, healthy volunteers.
Detailed Description:
This is an interventional, drug-drug interaction study to evaluate the effect of daily doses of Obicetrapib tablets on the pharmacokinetics of a combined oral contraceptive (COC), Drospirenone and Ethinyl Estradiol.
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?: