CompletedPhase 1

Bioavailability of Belumosudil (KD025) in Healthy Male Subjects

United Kingdom23 participantsStarted 2015-09

Plain-language 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.

Who can participate

Age range18 Years – 55 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Healthy males
✓. Aged 18 to 55 years of age
✓. Good state of health (mentally and physically) as indicated by a comprehensive clinical assessment (detailed medical history and a complete physical examination), ECG, and laboratory investigations (hematology, coagulation, clinical chemistry and urinalysis)
✓. Body mass index 18.0-30.0 kg/m\^2, or if outside the range, considered not clinically significant by the Investigator
✓. Willing and able to communicate and participate in the whole study
✓. Provide written informed consent
✓. Agree to use an adequate method of contraception for up to 90 days post discharge

Exclusion criteria

✕. Participated in a clinical research study within the previous 3 months
✕. Study site employees, or immediate family members of a study site or sponsor employee
✕. Had been previously enrolled in this study
✕. History of any drug or alcohol abuse in the past 2 years
✕. Regular alcohol consumption \> 21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
✕. Current smokers and those who had smoked within the last 12 months. A breath carbon monoxide (CO) reading of greater than 10 ppm at screening
✕. Did not have suitable veins for multiple venepunctures/cannulation as assessed by the Investigator at screening
✕. Clinically significant abnormal biochemistry, hematology, coagulation, or urinalysis as judged by the Investigator

What they're measuring

Pharmacokinetics: Cmax of Dosing Regimen A (Tablets--Fasting) vs. Dosing Regimen B (Tablets--Fed) for KD025, KD025m1, and KD025m2 at 48 Hours Post-dose

Timeframe: Pre-dose (0), and 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours post-dose

Pharmacokinetics: AUCs of Dosing Regimen A (Tablets--Fasting) vs. Dosing Regimen B (Tablets--Fed) for KD025, KD025m1, and KD025m2 at 48 Hours Post-dose

Timeframe: Pre-dose (0), and 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours post-dose

Trial details

NCT IDNCT02557139

SponsorKadmon Corporation, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-10-12

Results submitted2021-08-13

View on ClinicalTrials.gov More Bioavailability trials

Who can participate

Age range18 Years – 55 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Healthy males
✓. Aged 18 to 55 years of age
✓. Good state of health (mentally and physically) as indicated by a comprehensive clinical assessment (detailed medical history and a complete physical examination), ECG, and laboratory investigations (hematology, coagulation, clinical chemistry and urinalysis)
✓. Body mass index 18.0-30.0 kg/m\^2, or if outside the range, considered not clinically significant by the Investigator
✓. Willing and able to communicate and participate in the whole study
✓. Provide written informed consent
✓. Agree to use an adequate method of contraception for up to 90 days post discharge

Exclusion criteria

✕. Participated in a clinical research study within the previous 3 months
✕. Study site employees, or immediate family members of a study site or sponsor employee
✕. Had been previously enrolled in this study
✕. History of any drug or alcohol abuse in the past 2 years
✕. Regular alcohol consumption \> 21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
✕. Current smokers and those who had smoked within the last 12 months. A breath carbon monoxide (CO) reading of greater than 10 ppm at screening
✕. Did not have suitable veins for multiple venepunctures/cannulation as assessed by the Investigator at screening
✕. Clinically significant abnormal biochemistry, hematology, coagulation, or urinalysis as judged by the Investigator

What they're measuring

Pharmacokinetics: Cmax of Dosing Regimen A (Tablets--Fasting) vs. Dosing Regimen B (Tablets--Fed) for KD025, KD025m1, and KD025m2 at 48 Hours Post-dose

Timeframe: Pre-dose (0), and 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours post-dose

Pharmacokinetics: AUCs of Dosing Regimen A (Tablets--Fasting) vs. Dosing Regimen B (Tablets--Fed) for KD025, KD025m1, and KD025m2 at 48 Hours Post-dose

Timeframe: Pre-dose (0), and 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours post-dose