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

Healthy Volunteers Clinical Trial

Official title:

A Study to Evaluate the Effect of Daily Doses of Obicetrapib Tablets on the Pharmacokinetics of Drospirenone and Ethinyl Estradiol in Healthy Adult Female Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06250205
• Other study ID #: TA-8995-13
• Status: Recruiting
• Phase: Phase 1
• Start date: February 5, 2024
• Est. completion date: August 30, 2024

Study information

• Verified date: January 2024
• Source: NewAmsterdam Pharma
• Contact: Linda Angeline
• Phone: 702 435 3739
• Email: LAngeline[@]novumprs.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 30, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Obicetrapib
oral administration
• Obicetrapib + Drospirenone / Ethinyl Estradiol (COC)
oral administration
• Drospirenone / Ethinyl Estradiol (COC)
oral administration

Locations

Country	Name	City	State
United States	NOVUM	Las Vegas	Nevada

Sponsors (2)

Lead Sponsor	Collaborator
NewAmsterdam Pharma	Novum

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Area under the plasma concentration-time (AUC0-t) curve for COC with and without coadministration with Obicetrapib	Plasma AUC0-t for COC with and without coadministration of Obicetrapib	Upon completion of Treatment C (Day -6) and Treatments B+C (Day 12)