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

Last updated: September 14, 2024
Sponsor: NewAmsterdam Pharma
Overall Status: Completed

Phase

1

Condition

Healthy Volunteers

Treatment

Drospirenone / Ethinyl Estradiol (COC)

Obicetrapib + Drospirenone / Ethinyl Estradiol (COC)

Obicetrapib

Clinical Study ID

NCT06250205
TA-8995-13
  • Ages 18-35
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Non-pregnant, non-lactating, non-tobacco-, non-nicotine-using female, 18-35 years ofage, inclusive, who is a candidate for hormonal contraception (as determined by theInvestigator).

  • Subject has a BMI of 18.5-29.9 kg/m², inclusive. BMI will be calculated using NovumPharmaceutical Research Services Standard Operating Procedures.

  • If the subject is currently using a hormonal method of contraception, the subject iswilling and agrees to stop using her hormonal contraceptive throughout the durationof the study and is prepared to abstain from sexual intercourse or use a reliablenon-hormonal method of contraception, as outlined below

Exclusion

Exclusion Criteria:

  • Male

  • Have given birth or been pregnant within 3 months before initial dosing, or iscurrently 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 Design

Total Participants: 30
Treatment Group(s): 5
Primary Treatment: Drospirenone / Ethinyl Estradiol (COC)
Phase: 1
Study Start date:
February 05, 2024
Estimated Completion Date:
April 26, 2024

Study 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.

Connect with a study center

  • NOVUM

    Las Vegas, Nevada 89121
    United States

    Site Not Available

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