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

Not Applicable

Not yet recruiting

• Conditions: Healthy Participants
• Interventions: Drug: Vimseltinib; Drug: Rosuvastatin

• Registration Number: NCT07158398
• Lead Sponsor: Deciphera Pharmaceuticals, LLC

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 available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-28
• Study First Submitted QC: 2025-08-28
• Last Update Submitted: 2025-08-28
• Study First Posted: 2025-09-05
• Last Update Posted: 2025-09-05
• Study Start: 2025-10-01
• Primary Completion: 2026-06
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 20

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 18 to 32 kilogram per square meter (kg/m^2).
3. Adequate organ function and 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Rosuvastatin + Vimseltinib	Vimseltinib	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.
Rosuvastatin + Vimseltinib	Rosuvastatin	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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