Evaluate the Effect of Vimseltinib on Pharmacokinetics of Combined Oral Contraceptive (Ethinyl Estradiol/Levonorgestrel)

Purpose

The main purpose of this study is to determine the effect of vimseltinib on pharmacokinetics of combined oral contraceptive (COC) (ethinyl estradiol/levonorgestrel) in healthy female participants. This study will last approximately 35 days.

Condition

  • Healthy Participants

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  1. Participants are in good general health, as required by the protocol and as determined by Principal Investigator. 2. Body mass index (BMI) from greater than or equal to (≥) 18.5 to less than or equal to ≤ 30 kilogram per square meter (kg/m^2). 3. Adequate organ function, blood and urine tests, as required by the protocol and as determined by Principal Investigator.

Exclusion Criteria

  1. History or presence of clinically significant diseases of the neurological, dermatological, renal, hepatic, gastrointestinal, cardiovascular, or musculoskeletal systems or history or presence of clinically significant psychiatric, immunological, endocrine, or metabolic disease as determined by Principal Investigator. 2. Unwilling or unable to comply with the requirements of the protocol. 3. Determined by Principal Investigator to be unsuitable to participate in the study for any other reason.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Vimseltinib + Combined Oral Contraceptive (COC) 		Day 1 single dose of combined oral contraceptive (COC) (ethinyl estradiol [EE]/levonorgestrel [LNG]). Day 4 through 7, Day 11 and Day 14 single daily dose of Vimseltinib. Day 18 coadministration of COC (EE /LNG) with vimseltinib.
  • Drug: Vimseltinib
    Administered orally
  • Drug: Combined Oral Contraceptive (COC) (ethinyl estradiol [EE]/levonorgestrel [LNG])
    Administered orally

Recruiting Locations

Nucleus Network
Saint Paul, Minnesota 55114
Contact:
Jennifer Bookey
651-641-2900
j.bookey@nucleusnetwork.com

More Details

Status
Recruiting
Sponsor
Deciphera Pharmaceuticals, LLC

Study Contact

Clinical Team
888-724-3274
clinicaltrials@deciphera.com