Study to Compare the Plasma Concentration of Belumosudil Given as an Oral Suspension and as a Tablet to Healthy Adult Male Participants

Sponsor
Sanofi
Study ID
NCT07726914
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Belumosudil — DRUG
    Pharmaceutical form:Tablet-Route of administration:Oral
  • Belumosudil — DRUG
    Pharmaceutical form:Oral suspension-Route of administration:Oral

Study Details

The purpose of this open-label, randomized, cross-over, Phase 1, 2-treatment, 2-period, 2-sequence study is to assess the bioequivalence of belumosudil oral suspension compared with belumosudil tablet in healthy male participants aged 18 to 45 years, inclusive. Study details include: The study duration will be approximately 40 days. The treatment period will be up to 8 days. At least 3 days post-treatment follow-up period. end of study: 6±1 days from the last dose. The number of visits will be 3.

Key Dates

First listed
Jul 24, 2026
Start date
Aug 6, 2026
Status verified
Jul 2026
Primary completion
Sep 28, 2026
Completion
Sep 28, 2026

Study Design

Enrollment
58 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: belumosudil tablet，then belumosudil oral suspension
    belumosudil tablet in period 1, then belumosudil oral suspension in period 2.
  • Experimental: belumosudil oral suspension, then belumosudil tablet
    belumosudil oral suspension in period 1, then belumosudil tablet in period 2.

Primary Outcome Measure

AUClast [ Time Frame: Baseline (H0) to Day 3 (H48) for each of the 2 periods ]

Central Contacts

  • Trial Transparency email recommended (Toll free for US & Canada)
    800-633-1610
    [email protected]

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