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

Deciphera Pharmaceuticals, LLC

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Rosuvastatin; Drug: Vimseltinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT07158398

DCC-3014-01-007

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Rosuvastatin + Vimseltinib

Experimental group

Description:

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.

Treatment:

Drug: Vimseltinib

Drug: Rosuvastatin