NCT04735822 - A Phase I Study to Evaluate the Taste of Belumosudil Oral Suspensions & Assess Relative Bioavailability | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

October 26, 2020

Primary Completion Date

September 3, 2021

Study Completion Date

September 3, 2021

Conditions

Healthy Volunteers

Interventions

DRUG

Part 1: Belumosudil 40 mg/mL Sequence ABFCED

Oral suspension belumosudil 40 mg/mL in sequence Regimen A, then Regimen B, then Regimen F, then Regimen C, then Regimen E, then Regimen D

DRUG

Part 1: Belumosudil 40 mg/mL Sequence BCADFE

Oral suspension belumosudil 40 mg/mL in sequence Regimen B, then Regimen C, then Regimen A, then Regimen D, then Regimen F, then Regimen E

DRUG

Part 1: Belumosudil 40 mg/mL Sequence CDBEAF

Oral suspension belumosudil 40 mg/mL in sequence Regimen C, then Regimen D, then Regimen B, then Regimen E, then Regimen A, then Regimen F

DRUG

Part 1: Belumosudil 40 mg/mL Sequence DECFBA

Oral suspension of belumosudil 40 mg/mL in sequence Regimen D, then Regimen E, then Regimen C, then Regimen F, then Regimen B, then Regimen A

DRUG

Part 1: Belumosudil 40 mg/mL Sequence EFDACB

Oral suspension of belumosudil 40 mg/mL in sequence Regimen E, then Regimen F, then Regimen D, then Regimen A, then Regimen C, then Regimen C

DRUG

Part 1: Belumosudil 40 mg/mL Sequence FAEBDC

Oral suspension of belumosudil 40 mg/mL in sequence Regimen F, then Regimen A, then Regimen E, then Regimen B, then Regimen D, then Regimen C

DRUG

Part 2: Belumosudil 200 mg Sequence GHI

1 dose of belumosudil 200 mg in sequence Regimen G (tablet), then Regimen H (oral suspension; subject fasted), then Regimen I (oral suspension; subject fed)

DRUG

Part 2: Belumosudil 200 mg Sequence HIG

1 dose of belumosudil 200 mg in sequence Regimen H (oral suspension; subject fasted), then Regimen I (oral suspension; subject fed), then Regimen G (tablet)

DRUG

Part 2: Belumosudil 200 mg Sequence IGH

1 dose of belumosudil 200 mg in sequence Regimen I (oral suspension; subject fed), then Regimen G (tablet), then Regimen H (oral suspension, subject fasted)

DRUG

Part 2: Belumosudil 200 mg Sequence IHG

1 dose of belumosudil 200 mg in sequence Regimen I (oral suspension; subject fed), then Regimen H (oral suspension; subject fasted), then Regimen G (tablet)

DRUG

Part 2: Belumosudil 200 mg Sequence GIH

1 dose of belumosudil 200 mg in sequence Regimen G (tablet), then Regimen I (oral suspension; subject fed), then Regimen H (oral suspension; subject fasted)

DRUG

Part 2: Belumosudil 200 mg Sequence HGI

1 dose of belumosudil 200 mg in sequence Regimen H (oral suspension; subject fasted), then Regimen G (tablet), then Regimen I (oral suspension; subject fed)

Trial Locations (1)

NG11 6J5

Quotient Sciences, Nottingham

All Listed Sponsors

collaborator

Quotient Sciences

INDUSTRY

lead

Kadmon Corporation, LLC

INDUSTRY