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

NewAmsterdam Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Obicetrapib + Drospirenone / Ethinyl Estradiol (COC); Drug: Drospirenone / Ethinyl Estradiol (COC); Drug: Obicetrapib

Study type: Interventional

Funder types: Industry

Identifiers

NCT06250205

TA-8995-13

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

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

Experimental group

Description:

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

Treatment:

Drug: Obicetrapib

Drug: Obicetrapib + Drospirenone / Ethinyl Estradiol (COC)

Treatment B: Obicetrapib

Experimental group

Description:

Obicetrapib 10 mg tablets (daily)

Treatment:

Drug: Obicetrapib

Treatment C: Drospirenone/Ethinyl Estradiol tablets (COC)

Experimental group

Description:

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

Treatment:

Drug: Drospirenone / Ethinyl Estradiol (COC)