How vimseltinib affects levels of a combined birth control pill
A Phase 1, Open-label, Fixed-sequence Study to Evaluate the Effect of Vimseltinib on Pharmacokinetics of Combined Oral Contraceptive (Ethinyl Estradiol/Levonorgestrel) in Healthy Female Participants
This study will test whether taking vimseltinib changes blood levels of the combined oral contraceptive (ethinyl estradiol/levonorgestrel) in healthy women.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | Deciphera Pharmaceuticals, LLC Industry-sponsored |
| Drugs / interventions | vimseltinib |
| Locations | 1 site (Saint Paul, Minnesota) |
| Trial ID | NCT07539090 on ClinicalTrials.gov |
What this trial studies
This Phase 1 pharmacokinetic study enrolls healthy female participants and lasts about 35 days. Participants will take the combined oral contraceptive and then receive vimseltinib while serial blood samples are collected to measure ethinyl estradiol and levonorgestrel concentrations. Measured drug and hormone levels will be compared to determine whether vimseltinib alters contraceptive exposure. Findings will help guide safe use and labeling for vimseltinib with hormonal contraception.
Who should consider this trial
Good fit: Healthy women who meet protocol criteria (BMI 18.5–30 kg/m2, normal labs/organ function, and able to comply with study procedures) and can take the specified combined oral contraceptive are eligible.
Not a fit: People with clinically significant medical conditions, abnormal labs, BMI outside the allowed range, or who cannot take the combined oral contraceptive or vimseltinib are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, the results could help doctors know whether vimseltinib affects birth control pill effectiveness or safety and inform prescribing guidance.
How similar studies have performed: Drug–drug pharmacokinetic studies with cancer drugs and hormonal contraceptives are common and have previously shown that some medications can change hormone levels, so the approach is established though results vary by drug.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Saint Paul, Minnesota
- Nucleus Network — Saint Paul, Minnesota, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Team
- Email: clinicaltrials@deciphera.com
- Phone: 888-724-3274
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.