Healthy Volunteers
Conditions
Keywords
DDI, drug-drug interaction, combined oral contraceptive
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.
Detailed 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.
Interventions
DRUGObicetrapib
oral administration
DRUGObicetrapib + Drospirenone / Ethinyl Estradiol (COC)
oral administration
DRUGDrospirenone / Ethinyl Estradiol (COC)
oral administration
Sponsors
Novum
NewAmsterdam Pharma
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label, multiple-dose, fixed sequence, drug-drug interaction study.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of COC | Upon completion of Treatment C (Day -6) and Treatments B+C (Day 12) | Plasma Cmax concentration of COC with and without Obicetrapib |
| Area under the plasma concentration-time (AUC0-τ) curve for COC with and without coadministration with Obicetrapib | Upon completion of Treatment C (Day -6) and Treatments B+C (Day 12) | Plasma AUC0-τ for COC with and without coadministration of Obicetrapib |
Countries
United States
Outcome results
None listed