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

Part of paid clinical trials in Las Vegas, Nevada.

Sponsor
NewAmsterdam Pharma
Study ID
NCT06250205
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 35 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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

Key Dates

Start date
Feb 5, 2024
Status verified
Sep 2024
Primary completion
Apr 25, 2024
Completion
Apr 26, 2024

Study Design

Enrollment
30 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment B+C: Obicetrapib + Drospirenone/Ethinyl Estradiol (COC)
    Obicetrapib 10 mg tablets and Drospirenone (3mg)/Ethinyl Estradiol (0.02mg) tablet
  • Experimental: Treatment B: Obicetrapib
    Obicetrapib 10 mg tablets (daily)
  • Experimental: Treatment C: Drospirenone/Ethinyl Estradiol tablets (COC)
    Drospirenone (3mg)/Ethinyl Estradiol tablets (0.02mg) tablet

Primary Outcome Measure

Maximum observed plasma concentration (Cmax) of COC [ Time Frame: Upon completion of Treatment C (Day -6) and Treatments B+C (Day 12) ]

Locations (1)

FacilityCityStateZIPSite coordinators
NOVUMLas VegasNevada89121-

Find similar trials in Las Vegas, NV

By research site
NOVUM· Las Vegas, NV

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