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

NCT07158398 | Completed Phase 1 FDA Drug

• 1 other identifier: DCC-3014-01-007
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (2)

• 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 (1)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  Baseline through Day 26

Study Arms (1)

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

Vimseltinib DRUG

Administered orally

Rosuvastatin + Vimseltinib

Rosuvastatin DRUG

Administered orally

Rosuvastatin + Vimseltinib

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Deciphera Pharmaceuticals, LLC: lead

Study Sites (1)

Dr. Vince Clinical Research

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Interventions

Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Clinical Team

  Deciphera Pharmaceuticals, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 5, 2025
• Study Start: October 31, 2025
• Primary Completion: December 8, 2025
• Study Completion: December 8, 2025
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)