Clinical Trials Logo

Clinical Trial Summary

Phase 1 bioavailability study to evaluate the pharmacokinetics (PK) and tolerability/safety of the belumosudil tablet formulation in the fasted and fed states and compared to the belumosudil capsule formulation in the fed state.


Clinical Trial Description

This is a Phase 1, 3-way, crossover, randomized, open-label study in healthy subjects designed to compare the bioavailability of belumosudil (previously known as KD025) tablet formulation administered in the fed and fasted states and to assess the relative bioavailability of belumosudil tablet and capsule formulations in the fed state. The primary objective of the study is to determine the PK parameters of belumosudil tablet formulation in the fed and fasted states. The secondary objectives of the study are: (1) to assess the relative bioavailability of a tablet (test) to capsule (reference formulation of belumosudil; (2) to assess and compare the variability in the maximum concentration (Cmax) and area under the concentration-time curve (AUC) for belumosudil treatments (belumosudil 200 mg tablet in the fasting state, belumosudil 200 mg tablet in the fed state, and belumosudil as two 100 mg capsules in the fed state); and (3) to provide additional safety and tolerability information for belumosudil. This is a single-center, open-label, randomized, single-dose, 3-period, 3-way, crossover study in healthy subjects. In each of 3 study periods, each subject receives 1 of the following single-dose treatments: - Regimen A: Belumosudil 200 mg tablet in the fasted state - Regimen B: Belumosudil 200 mg tablet in the fed state - Regimen C: Belumosudil 200 mg as two 100-mg capsules in the fed state Subjects are randomized to receive 1 dose of investigational product (IP; belumosudil tablet or capsule) in the morning of Day 1 in a randomized manner following an overnight fast or a high-fat breakfast. Administration is performed on Day 1 with an appropriate interval between subjects based on logistical requirements. Start time is determined based on logistics. Subjects undergo a screening visit in the 21 days preceding first dose. Subjects are admitted to the clinical unit on the evening prior to dosing (Day -1), remain on site until 24 hours post-dose, and return to the clinic at 36 and 48 hours post-dose for PK assessments. There is a minimum washout period of 6 days between each dose administration. All other meals are standardized for each of the in-clinic phases of the 3 treatment periods. Each period follows the same study design. The randomized cohorts for the 3-periods were as follows: - Cohort ABC: Regimen A (Period 1); Regimen B (Period 2); Regimen C (Period 3) - Cohort BCA: Regimen B (Period 1); Regimen C (Period 2); Regimen A (Period 3) - Cohort CAB: Regimen C (Period 1); Regimen A (Period 2); Regimen B (Period 3) A follow-up call is made 3 to 5 days after the final dose of IP. Planned enrollment is 24 subjects to insure there are 20 evaluable subjects. A subject is considered evaluable if (s)he completes treatment with fasted and fed tablet formulations (Regimens A and B) without major protocol deviations. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02557139
Study type Interventional
Source Kadmon Corporation, LLC
Contact
Status Completed
Phase Phase 1
Start date September 2015
Completion date October 12, 2015

See also
  Status Clinical Trial Phase
Completed NCT06043739 - Relative Bioavailability and Effect of Food Study With an Oral Mini-tablet Formulation of Filgotinib in Healthy Subjects Phase 1
Completed NCT02010944 - A Study to Compare How Much Solifenacin Succinate and Mirabegron Reach the Blood When Administered Together as Fixed-dose Combination Tablets and With Single Individual Tablets of the Same Medications at Three Dose Levels Phase 1
Not yet recruiting NCT01136551 - Comparative Bioavailability Study of an Immediate Release and Controlled Release Oral Formulations of Huperzine A N/A
Completed NCT01208155 - Study in Healthy Males to Assess Bioavailability of 4 Different Fostamatinib Tablets Phase 1
Completed NCT04097808 - Impact of the Source and Food Matrices on the Bioavailability of Peptan® (Collagen Peptides) in Healthy Subjects N/A
Active, not recruiting NCT06098001 - Bioavailability Study of Hemp Phenolics N/A
Completed NCT01912144 - Absorption of Phenolic Acids From Coffee in Humans N/A
Completed NCT03915626 - Effect of Heat on Rivastigmine TDS Products Early Phase 1
Completed NCT01448772 - Comparative Bioavailability of Dronabinol Oral Solution Versus Branded Capsule 5 mg Under Fasting Conditions Phase 1
Completed NCT01464450 - Pharmacokinetics Study of Oral Rivaroxaban in Healthy Participants Phase 1
Completed NCT01181973 - Safety, Tolerability and Relative Bioavailability of Pegvisomant in Healthy Subjects Phase 1
Completed NCT00858767 - Arabic Gum-Absorption Study N/A
Completed NCT04113564 - Absolute Oral Bioavailability of Remimazolam Phase 1
Completed NCT04645394 - Bioavailability of Anthocyanins From Aronia Extract in Healthy Men - a Pilot Study N/A
Completed NCT03485885 - Bioavailability of Maqui Berry Extract (MBE) in Healthy Subjects
Completed NCT05840848 - Effect of Iron and Zinc Supplementation on B-carotene Bioavailability in Healthy Males N/A
Completed NCT02986529 - A Study to Assess the Bioavailability of Oral Sodium Oligo-mannurarate (GV-971) in Healthy Chinese Male Subjects Phase 1
Completed NCT01789359 - Urinary Excretion of Anthocyanins During Long Term Blueberry Feeding N/A
Completed NCT01638143 - Bio-equivalence Study N/A
Completed NCT00755872 - Assess the Influence of a High-fat Meal on the Relative Bioavailability Of Two Formulations of Risedronate Phase 1