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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-05

Study Completion Date

2024-04-26

Brief Summary

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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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Detailed Description

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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

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Open-label, multiple-dose, fixed sequence, drug-drug interaction study.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment B+C: Obicetrapib + Drospirenone/Ethinyl Estradiol (COC)

Obicetrapib 10 mg tablets and Drospirenone (3mg)/Ethinyl Estradiol (0.02mg) tablet

Group Type EXPERIMENTAL

Obicetrapib

Intervention Type DRUG

oral administration

Obicetrapib + Drospirenone / Ethinyl Estradiol (COC)

Intervention Type DRUG

oral administration

Treatment B: Obicetrapib

Obicetrapib 10 mg tablets (daily)

Group Type EXPERIMENTAL

Obicetrapib

Intervention Type DRUG

oral administration

Treatment C: Drospirenone/Ethinyl Estradiol tablets (COC)

Drospirenone (3mg)/Ethinyl Estradiol tablets (0.02mg) tablet

Group Type EXPERIMENTAL

Drospirenone / Ethinyl Estradiol (COC)

Intervention Type DRUG

oral administration

Interventions

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Obicetrapib

oral administration

Intervention Type DRUG

Obicetrapib + Drospirenone / Ethinyl Estradiol (COC)

oral administration

Intervention Type DRUG

Drospirenone / Ethinyl Estradiol (COC)

oral administration

Intervention Type DRUG

Other Intervention Names

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10 mg tablet tablets tablets

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes