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OpenTrials
Completed

NCT Number: NCT07158398

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

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.

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Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Dr. Vince Clinical Research

Overland Park, Kansas, 66212, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vimseltinib

Drug

Administered orally

Rosuvastatin

Drug

Administered orally

Primary outcomes

  1. Pharmacokinetic (PK): Maximum Observed Plasma Drug Concentration (Cmax) of rosuvastatin

    Time frame: Predose up to 72 hours postdose

  2. PK: Area Under the Concentration Versus Time Curve (AUC) of rosuvastatin

    Time frame: Predose up to 72 hours postdose

Secondary outcomes

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

    Time frame: Baseline through Day 26

Sponsors and collaborators

Lead sponsor

Deciphera Pharmaceuticals, LLC

Industry

Registry information

Official study title

A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Vimseltinib on BCRP and OATP1B1 Inhibition in Healthy Male Participants

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 5, 2025
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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