NCT06250205

Evaluate the Pharmacokinetics of a Combined Oral Contraceptive (COC) With and Without Obicetrapib

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: NewAmsterdam Pharma · Industry
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Obicetrapib	oral administration
DRUG	Obicetrapib + Drospirenone / Ethinyl Estradiol (COC)	oral administration
DRUG	Drospirenone / Ethinyl Estradiol (COC)	oral administration

Timeline

• Start date: 2024-02-05
• Primary completion: 2024-04-25
• Completion: 2024-04-26
• First posted: 2024-02-08
• Last updated: 2024-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study