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OpenTrials
Completed

NCT Number: NCT06250205

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

A study to evaluate the impact of Obicetrapib on the PK levels of Drospirenone and Ethinyl Estradiol (COC) in 30 adult female, healthy volunteers.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

NOVUM

Las Vegas, Nevada, 89121, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Obicetrapib

Drug

oral administration

Other names: 10 mg tablet

Obicetrapib + Drospirenone / Ethinyl Estradiol (COC)

Drug

oral administration

Other names: tablets

Drospirenone / Ethinyl Estradiol (COC)

Drug

oral administration

Other names: tablets

Primary outcomes

  1. Maximum observed plasma concentration (Cmax) of COC

    Time frame: Upon completion of Treatment C (Day -6) and Treatments B+C (Day 12)

    Plasma Cmax concentration of COC with and without Obicetrapib

  2. Area under the plasma concentration-time (AUC0-τ) curve for COC with and without coadministration with Obicetrapib

    Time frame: Upon completion of Treatment C (Day -6) and Treatments B+C (Day 12)

    Plasma AUC0-τ for COC with and without coadministration of Obicetrapib

Sponsors and collaborators

Lead sponsor

NewAmsterdam Pharma

Industry

Collaborators

  • Novum

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 8, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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