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

NCT06250205 | Completed Phase 1 FDA Drug

• 1 other identifier: TA-8995-13
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

DDI, drug-drug interaction, combined oral contraceptive

Outcome Measures

Primary Outcomes (2)

• Maximum observed plasma concentration (Cmax) of COC

  Plasma Cmax concentration of COC with and without Obicetrapib

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

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

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

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

Study Arms (3)

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

EXPERIMENTAL

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

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

Treatment B: Obicetrapib

EXPERIMENTAL

Obicetrapib 10 mg tablets (daily)

Drug: Obicetrapib

Treatment C: Drospirenone/Ethinyl Estradiol tablets (COC)

EXPERIMENTAL

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

Drug: Drospirenone / Ethinyl Estradiol (COC)

Interventions

Obicetrapib DRUG

oral administration

Also known as: 10 mg tablet

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

Obicetrapib + Drospirenone / Ethinyl Estradiol (COC) DRUG

oral administration

Also known as: tablets

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

Drospirenone / Ethinyl Estradiol (COC) DRUG

oral administration

Also known as: tablets

Treatment C: Drospirenone/Ethinyl Estradiol tablets (COC)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NewAmsterdam Pharma: lead
• Novum: collaborator

Study Sites (1)

NOVUM

Las Vegas, Nevada, 89121, United States

Location

MeSH Terms

Interventions

Tablets; drospirenone; Ethinyl Estradiol

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Kent A Swaine

  Novum Pharmaceutical Research Services, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 8, 2024
• Study Start: February 5, 2024
• Primary Completion: April 25, 2024
• Study Completion: April 26, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)