Vimseltinib for Oral Contraceptive Interaction
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine how vimseltinib affects the body's processing of a common oral contraceptive (birth control pill). The focus is on whether vimseltinib alters the metabolism of the pill's ingredients, ethinyl estradiol and levonorgestrel. The trial seeks healthy women willing to take both the birth control pill and vimseltinib as part of the study. Participants should be in good health with a BMI between 18.5 and 30. As a Phase 1 trial, this research explores how vimseltinib functions in people, offering participants the chance to be among the first to receive this new treatment.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, since the study focuses on the interaction with oral contraceptives, you may need to continue taking them as part of the trial.
Is there any evidence suggesting that vimseltinib is likely to be safe for humans?
Research has shown that vimseltinib can cause serious side effects, including liver issues. Studies have found that people taking vimseltinib often experience elevated liver enzyme levels in their blood, indicating potential liver stress or dysfunction. However, no information exists on how vimseltinib affects pregnant women. Considering these factors is crucial when deciding whether to join a trial involving vimseltinib.12345
Why do researchers think this study treatment might be promising?
Vimseltinib is unique because it offers a new approach by interacting with combined oral contraceptives (COCs) in a potentially beneficial way. Unlike standard oral contraceptives, which primarily rely on hormones like ethinyl estradiol and levonorgestrel to prevent pregnancy, Vimseltinib is a kinase inhibitor that might alter how these hormones are metabolized, potentially improving their efficacy or safety profile. Researchers are excited about this because it could lead to more effective contraceptive options with possibly fewer side effects, marking a significant advancement in reproductive health.
What evidence suggests that vimseltinib might affect the pharmacokinetics of oral contraceptives?
This trial studies vimseltinib to understand its interaction with birth control pills. Although limited information exists on its effectiveness in this context, research has shown that vimseltinib can alter drug metabolism, affecting how other drugs work. It has been tested for other uses, such as treating certain tumors, and has shown potential. Vimseltinib targets specific cell components that can influence the function of other medications. This study aims to explore its interaction with birth control pills further.12356
Who Is on the Research Team?
Clinical Team
Principal Investigator
Deciphera Pharmaceuticals, LLC
Are You a Good Fit for This Trial?
This trial is for healthy women with a BMI between 18.5 and 30, who have normal organ function and no significant medical conditions. Participants must be able to follow study instructions and pass required health checks.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of combined oral contraceptive on Day 1, followed by daily doses of Vimseltinib from Day 4 through 7, Day 11, and Day 14, with coadministration of COC and Vimseltinib on Day 18
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Vimseltinib
Trial Overview
The study tests how the drug vimseltinib affects the way the body processes a common birth control pill (ethinyl estradiol/levonorgestrel) in healthy women over about 35 days.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
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Who Is Running the Clinical Trial?
Deciphera Pharmaceuticals, LLC
Lead Sponsor
Citations
NCT07539090 | Evaluate the Effect of Vimseltinib on ...
The main purpose of this study is to determine the effect of vimseltinib on pharmacokinetics of combined oral contraceptive (COC) (ethinyl ...
Evaluation of the potential for pharmacokinetic interaction ...
The objective of this study was to evaluate the effect of concomitant administration of TIRA 160 mg once‐daily on the exposure of ethinyl estradiol (EE) and ...
Vimseltinib for Oral Contraceptive Interaction
The main purpose of this study is to determine the effect of vimseltinib on pharmacokinetics of combined oral contraceptive (COC) (ethinyl ...
4.
ctv.veeva.com
ctv.veeva.com/study/evaluate-the-effect-of-vimseltinib-on-pharmacokinetics-of-combined-oral-contraceptive-ethinyl-estraEvaluate the Effect of Vimseltinib on Pharmacokinetics of ...
The main purpose of this study is to determine the effect of vimseltinib on pharmacokinetics of combined oral contraceptive (COC) (ethinyl ...
Evaluation of the potential for pharmacokinetic interaction ...
A drug–drug interaction study to evaluate the effect of TIRA on the pharmacokinetics of the oral contraceptive levonorgestrel (LEVO)/ethinyl estradiol (EE) was ...
6.
trial.medpath.com
trial.medpath.com/clinical-trial/de19437ab2ebc82b/nct07539090-vimseltinib-effect-on-oral-contraceptive-pharmacokineticsEvaluate the Effect of Vimseltinib on Pharmacokinetics of ...
The main purpose of this study is to determine the effect of vimseltinib on pharmacokinetics of combined oral contraceptive (COC) (ethinyl estradiol/ ...
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