Healthy ParticipantsPhase 1NCT07539090

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

A Phase 1 study testing Vimseltinib and Combined Oral Contraceptive (COC) (ethinyl estradiol [EE]/levonorgestrel [LNG]) in people with Healthy Participants, run by Deciphera Pharmaceuticals, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: Vimseltinib and Combined Oral Contraceptive (COC) (ethinyl estradiol [EE]/levonorgestrel [LNG])
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteUnited States
Study dates: 5 Jun 2026to 8 Oct 2026
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Participants are in good general health, as required by the protocol and as determined by Principal Investigator.
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).
Adequate organ function, blood and urine tests, as required by the protocol and as determined by Principal Investigator.

Who cannot join

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.
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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Nucleus Network
Saint Paul, Minnesota, 55114

Other trials in United States

About this study

Official title: 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

Conditions: Healthy Participants
Being tested: Vimseltinib, Combined Oral Contraceptive (COC) (ethinyl estradiol [EE]/levonorgestrel [LNG])

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VimseltinibDrug
Administered orally
Combined Oral Contraceptive (COC) (ethinyl estradiol [EE]/levonorgestrel [LNG])Drug
Administered orally

Study groups in NCT07539090
Study group	Role	What they receive
Vimseltinib + Combined Oral Contraceptive (COC)	Experimental	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. Receives: Drug: Vimseltinib; Drug: Combined Oral Contraceptive (COC) (ethinyl estradiol [EE]/levonorgestrel [LNG])

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics (PK): Maximum Observed Plasma Drug Concentration (Cmax) of EE and LNG
Measured: Predose up to 72 Hours Post Dose
PK: Area Under the Plasma Concentration-Time Curve from Time 0 up to Time t (AUC0-t), Where t is the Last Time Point at which the Concentration is Above the Lower Limit of Quantification, of EE and LNG
Measured: Predose up to 72 Hours Post Dose
PK: AUC from Time 0 to Infinity (AUC0-∞) of EE and LNG
Measured: Predose up to 72 Hours Post Dose

Secondary outcomes (7)

PK: Apparent Systemic Clearance (CL/F) of EE and LNG
Measured: Predose up to 72 Hours Post Dose
PK: Apparent Volume of Distribution Associated with the Terminal Phase (Vz/F) of EE and LNG
Measured: Predose up to 72 Hours Post Dose
PK: Time to Maximum Observed Plasma Concentration (Tmax) of EE and LNG
Measured: Predose up to 72 Hours Post Dose
PK: Terminal Elimination Phase Half-Life (t1/2) of EE and LNG
Measured: Predose up to 72 Hours Post Dose
Safety: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: Baseline through Day 35
Safety: Number of Participants with Clinically Significant Change from Baseline in Clinical Laboratory Parameters
Measured: Baseline through Day 21
Safety: Number of Participants with Clinically Significant Change from Baseline in Vital Signs
Measured: Baseline through Day 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jun 20268 Oct 2026

First posted20 Apr 2026
Study start5 Jun 2026
Primary completion8 Oct 2026
Study completion8 Oct 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
More trials run by Deciphera Pharmaceuticals, LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07539090
Sponsor's protocol ID: DCC-3014-01-010
Status last verified: Oct 2026
First submitted: 13 Apr 2026
Last updated: 15 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT07539090
Acronym / sponsor ID: DCC-3014-01-010
Conditions: Healthy Participants
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Deciphera Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
Study start: 5 Jun 2026 (actual)
Primary completion: 8 Oct 2026 (actual)
Study completion: 8 Oct 2026 (actual)
First posted: 20 Apr 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Vimseltinib + Combined Oral Contraceptive (COC)	Experimental	Drug: Vimseltinib, Drug: Combined Oral Contraceptive (COC) (ethinyl estradiol [EE]/levonorgestrel [LNG])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.

Who may qualify

Ages: 18 to 55 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Participants are in good general health, as required by the protocol and as determined by Principal Investigator.
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).
Adequate organ function, blood and urine tests, as required by the protocol and as determined by Principal Investigator.

Key exclusion criteria (3 listed)

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.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VimseltinibAdministered orally	Drug	Vimseltinib + Combined Oral Contraceptive (COC)
Combined Oral Contraceptive (COC) (ethinyl estradiol [EE]/levonorgestrel [LNG])Administered orally	Drug	Vimseltinib + Combined Oral Contraceptive (COC)

Primary outcome

Pharmacokinetics (PK): Maximum Observed Plasma Drug Concentration (Cmax) of EE and LNG
Time frame: Predose up to 72 Hours Post Dose
PK: Area Under the Plasma Concentration-Time Curve from Time 0 up to Time t (AUC0-t), Where t is the Last Time Point at which the Concentration is Above the Lower Limit of Quantification, of EE and LNG
Time frame: Predose up to 72 Hours Post Dose
PK: AUC from Time 0 to Infinity (AUC0-∞) of EE and LNG
Time frame: Predose up to 72 Hours Post Dose

7 secondary outcomes

PK: Apparent Systemic Clearance (CL/F) of EE and LNG
Time frame: Predose up to 72 Hours Post Dose
PK: Apparent Volume of Distribution Associated with the Terminal Phase (Vz/F) of EE and LNG
Time frame: Predose up to 72 Hours Post Dose
PK: Time to Maximum Observed Plasma Concentration (Tmax) of EE and LNG
Time frame: Predose up to 72 Hours Post Dose
PK: Terminal Elimination Phase Half-Life (t1/2) of EE and LNG
Time frame: Predose up to 72 Hours Post Dose
Safety: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Baseline through Day 35
Safety: Number of Participants with Clinically Significant Change from Baseline in Clinical Laboratory Parameters
Time frame: Baseline through Day 21
Safety: Number of Participants with Clinically Significant Change from Baseline in Vital Signs
Time frame: Baseline through Day 21

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Team study director

Deciphera Pharmaceuticals, LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics (PK): Maximum Observed Plasma Drug Concentration (Cmax) of EE and LNG (time frame: Predose up to 72 Hours Post Dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07539090.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.