A Phase I Study to Evaluate the Taste of Belumosudil Oral Suspensions & Assess Relative Bioavailability
Status:
Completed
Trial end date:
2021-07-08
Target enrollment:
Participant gender:
Summary
This is a single-center, randomized, open-label, 2-part study in healthy male subjects to
evaluate the taste profile of different belumosudil oral suspensions and the relative
bioavailability of those chosen oral suspensions of belumosudil compared to oral tablets of
belumosudil.
Part 1 is an open-label, randomized single-period study of oral suspensions of belumosudil 40
mg/mL delivered in 6 different vehicles. Approximately 12 healthy male subjects, 2 subjects
in each of 6 groups, will be administered a single dose of belumosudil 40 mg/mL in 6
different vehicles (Vehicles 1, 2, 3, 4, 5, and 6) in corresponding Regimens A, B, C, D, E,
and F in different sequences of the 6 vehicles. All subjects will receive 1 dose of all
belumosudil in all 6 vehicles which are as follows: ABFCED; BCADFE; CDBEAF; DECFBA; EFDACB;
and FAEBDC.
Part 2 is a single-center, open-label, randomized, 3-period design to assess the relative
bioavailability of a selected belumosudil suspension formulation compared to the oral
belumosudil. Tablet reference and the effect of food on the selected belumosudil suspension
formulation in 18 healthy male subjects. Subjects will be randomized prior to the
administration of the first dose of IMP to 1 of 6 treatment sequences (GHI, HIG, IGH, IHG,
GIH and HGI), with 3 subjects assigned to each treatment sequence where:
Regimen G--oral belumosudil 200 mg tablet (reference) with the subject fed; Regimen
H--belumosudil powder 200 mg for oral suspension or belumosudil 200 mg oral suspension with
the subject fasting; and Regimen I--belumosudil 200 mg powder for oral suspension or
belumosudil 200 mg oral suspension with the subject fed.