24 Participants NeededMy employer runs this trial

Vimseltinib for Oral Contraceptive Interaction

CT
Overseen ByClinical Team
Age: 18 - 65
Sex: Female
Trial Phase: Phase 1
Sponsor: Deciphera Pharmaceuticals, LLC
Must be taking: Oral contraceptives
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

CT

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

Body mass index (BMI) from ≥ 18.5 to ≤ 30 kilogram per square meter (kg/m^2)
Participants are in good general health, as required by the protocol and as determined by Principal Investigator
My organ function and lab test results are within the required healthy range.

Exclusion Criteria

Unwilling or unable to comply with the requirements of the protocol
Determined by Principal Investigator to be unsuitable to participate in the study for any other reason
I do not have any serious ongoing health problems in major body systems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

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

18 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

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

Group I: Vimseltinib + Combined Oral Contraceptive (COC)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Deciphera Pharmaceuticals, LLC

Lead Sponsor

Trials
19
Recruited
2,100+

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 ...

Evaluate 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 ...

Evaluate 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/ ...