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NCT07726914

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

StatusNot Yet Recruiting
PhasePhase 1
SponsorSanofi
Primary completion (estimated)

At risk: Primary completion moved at least 3 months later.

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 13 words
  2. Start date: Aug 6, 2026 to Nov 17, 2026
    • Eligibility criteria expanded, about 23 words
    • Primary and study completion pushed from Sep 28, 2026 to Jan 26, 2027
    • Secondary endpoints: details revised at 2 of 6 entries
  3. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

AUClast
Timeframe: Baseline (H0) to Day 3 (H48) for each of the 2 periods
Cmax
Timeframe: Baseline (H0) to Day 3 (H48) for each of the 2 periods

Secondary (6)

tmax
t1/2z
tlag
AUC
AUClast/AUC
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λz

Arms and interventions

belumosudil tablet，then belumosudil oral suspensionExperimental

belumosudil tablet in period 1, then belumosudil oral suspension in period 2.

belumosudil oral suspension, then belumosudil tabletExperimental

belumosudil oral suspension in period 1, then belumosudil tablet in period 2.

Drugs: Belumosudil