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

ConditionChronic Graft Versus Host Disease
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-45
SponsorSanofi

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy male participant between 18 to 45 years of age, inclusive

Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).

Body weight between 50.0 and 115.0 kg, inclusive, and BMI between 18.0 and 32.0 kg/m2, inclusive

Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Disqualifiers

Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness

Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).

Blood donation (usually approximately 500 mL) within 2 months before inclusion

Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in SBP ≥30 mmHg within 3 minutes when changing from supine to standing position

Trial design

Design model

Crossover

Treatments tested in this trial

  • Belumosudil

    Drug

    Pharmaceutical form:Tablet-Route of administration:Oral

  • Belumosudil

    Drug

    Pharmaceutical form:Oral suspension-Route of administration:Oral

Treatment groups

58 Participants
are divided into 2 treatment groups
Group A: belumosudil tablet，then belumosudil oral suspensionExperimental treatment 1 intervention
Group B: belumosudil oral suspension, then belumosudil tabletExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

AUClast

Area under the plasma concentration versus time curve until the time of last quantifiable concentration

Time frame
Baseline (H0) to Day 3 (H48) for each of the 2 periods
2

Cmax

Maximum plasma concentration observed

Time frame
Baseline (H0) to Day 3 (H48) for each of the 2 periods

Secondary outcomes

1

tmax

Time to reach Cmax

Time frame
Baseline (H0) to Day 3 (H48) for each of the 2 periods
2

t1/2z

Terminal half-life associated with the terminal slope (λz)

Time frame
Baseline (H0) to Day 3 (H48) for each of the 2 periods
3

tlag

Interval between administration time and the sampling time preceding the first concentration above the limit of quantification

Time frame
Baseline (H0) to Day 3 (H48) for each of the 2 periods
4

AUC

Area under the plasma concentration versus time curve extrapolated to infinity

Time frame
Baseline (H0) to Day 3 (H48) for each of the 2 periods

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sanofi

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: