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

Phase 1

Recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: Drospirenone / Ethinyl Estradiol (COC); Drug: Obicetrapib; Drug: Obicetrapib + Drospirenone / Ethinyl Estradiol (COC)

• Registration Number: NCT06250205
• Lead Sponsor: NewAmsterdam Pharma

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 Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-02-01
• Study First Submitted QC: 2024-02-01
• Study Start: 2024-02-05
• Study First Posted: 2024-02-08
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-15
• Primary Completion: 2024-07-31
• Study Completion: 2024-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Non-pregnant, non-lactating, non-tobacco-, non-nicotine-using female, 18-35 years of age, inclusive, who is a candidate for hormonal contraception (as determined by the Investigator).
• Subject has a BMI of 18.5-29.9 kg/m², inclusive. BMI will be calculated using Novum Pharmaceutical Research Services Standard Operating Procedures.
• If the subject is currently using a hormonal method of contraception, the subject is willing and agrees to stop using her hormonal contraceptive throughout the duration of the study and is prepared to abstain from sexual intercourse or use a reliable non-hormonal method of contraception, as outlined below

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Exclusion Criteria

• Male
• Have given birth or been pregnant within 3 months before initial dosing, or is currently pregnant, lactating or likely to become pregnant during the study.
• History of Hypertension, or seated blood pressure for a minimum of 5 minutes >140mmHg systolic, or > 80 mmHg, diastolic at screening

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Treatment B+C: Obicetrapib + Drospirenone/Ethinyl Estradiol (COC)	Obicetrapib + Drospirenone / Ethinyl Estradiol (COC)	Obicetrapib 10 mg tablets and Drospirenone (3mg)/Ethinyl Estradiol (0.02mg) tablet
Treatment C: Drospirenone/Ethinyl Estradiol tablets (COC)	Drospirenone / Ethinyl Estradiol (COC)	Drospirenone (3mg)/Ethinyl Estradiol tablets (0.02mg) tablet
Treatment B: Obicetrapib	Obicetrapib	Obicetrapib 10 mg tablets (daily)
Treatment B+C: Obicetrapib + Drospirenone/Ethinyl Estradiol (COC)	Obicetrapib	Obicetrapib 10 mg tablets and Drospirenone (3mg)/Ethinyl Estradiol (0.02mg) tablet

Primary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration (Cmax) of COC	Upon completion of Treatment C (Day -6) and Treatments B+C (Day 12)	Plasma Cmax concentration of COC with and without Obicetrapib
Area under the plasma concentration-time (AUC0-τ) curve for COC with and without coadministration with Obicetrapib	Upon completion of Treatment C (Day -6) and Treatments B+C (Day 12)	Plasma AUC0-τ for COC with and without coadministration of Obicetrapib

Trial Locations

Locations (1)

NOVUM; 🇺🇸 Las Vegas, Nevada, United States