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

Recruiting
18 - 35 years of age
Female
Phase 1

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Overview

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

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.

Eligibility

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

Study details

Healthy Volunteers

NCT06250205

NewAmsterdam Pharma

23 February 2024

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