Evaluate the Effect of Vimseltinib on the Pharmacokinetic... | NCT07158398

Studies
Evaluate the Effect of Vimseltinib on the Pharmacokinetics of a BCRP and OATP1B1 Substrate

NCT07158398

Sponsor

Deciphera Pharmaceuticals, LLC

Status

Completed

Last Update Posted

Jan 15, 2026Actual

Enrollment

20Actual

Phase

Phase 1

Conditions

Healthy Participants

Interventions

Vimseltinib
Rosuvastatin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 31, 2025Actual

Primary Completion Date

Dec 8, 2025Actual

Completion Date

Dec 8, 2025Actual

First Submitted Date

Aug 28, 2025

First Submission Date that Met QC Criteria

Aug 28, 2025

First Posted Date

Sep 5, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2026

Last Update Posted Date

Jan 15, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The main purpose of this study is to determine the effect of Vimseltinib dosing on breast cancer resistance protein (BCRP) and organic-anion-transporting polypeptide 1 B1 (OAT1PB1) activity by using rosuvastatin in healthy male participants. This study will also evaluate the safety and tolerability when vimseltinib is co-administered with rosuvastatin in healthy male participants. This study will last approximately 26 days.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rosuvastatin + Vimseltinib	Experimental	Rosuvastatin as single dose will be administered on Day 1 and Day 8. Vimseltinib will be administered every day (QD) on Days 5 through 8.	Drug: Vimseltinib Drug: Rosuvastatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vimseltinib	Drug	Administered orally	Rosuvastatin + Vimseltinib
Rosuvastatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetic (PK): Maximum Observed Plasma Drug Concentration (Cmax) of rosuvastatin		Predose up to 72 hours postdose
PK: Area Under the Concentration Versus Time Curve (AUC) of rosuvastatin		Predose up to 72 hours postdose

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)		Baseline through Day 26

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants are in good general health, as required by the protocol and as determined by Principal Investigator.
Body mass index (BMI) from 18 to 32 kilogram per square meter (kg/m^2).
Adequate organ function and blood and urine tests, as required by the protocol and as determined by Principal Investigator.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Male

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Team	Deciphera Pharmaceuticals, LLC	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dr. Vince Clinical Research		Overland Park	Kansas	66212	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068718	Rosuvastatin Calcium

Ancestor Terms

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D005464	Fluorobenzenes

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