Status:
COMPLETED
A Phase I Study to Evaluate the Taste of Belumosudil Oral Suspensions & Assess Relative Bioavailability
Lead Sponsor:
Kadmon Corporation, LLC
Collaborating Sponsors:
Quotient Sciences
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-55 years
Phase:
EARLY_PHASE1
Brief Summary
This is a single-center, randomized, open-label, 2-part study in healthy male subjects to evaluate the taste profile of different belumosudil oral suspensions and the relative bioavailability of those...
Detailed Description
PART 1 This is a single center, open-label, randomized, single period design to assess the taste profile of different novel regimens from bottles containing 1200 mg of belumosudil. Twelve healthy sub...
Eligibility Criteria
Inclusion
- Healthy males
- Aged 18 to 55 years inclusive at the time of signing informed consent.
- Body mass index of 18.0 to 32.0 kg/m\^2 at screening
- Body weight ≥ 50 kg at screening
- Must be willing and able to communicate and participate in the entire study
- Must provide written informed consent
- Must agree to adhere to the contraception requirements
Exclusion
- Subjects who have received any IMP in a previous clinical research study within the 90 days prior to Day 1 (Part 2 only)
- Subjects who are or are immediate family members of a study site or sponsor employee
- Subjects who have previously been administered IMP in Part 2 of this study. Subjects who have taken part in Part 1 are permitted to take part in Part 2
- Evidence of current SARS-CoV-2 infection
- Clinically significant history or presence of acute or chronic bacterial, fungal, or viral infection (e.g., pneumonia, septicemia) within the 3 months or 90 days prior to screening
- Any subject with clinically significant symptoms of COVID-19 in the last 4 weeks, including but not limited to fever, new and persistent cough, breathlessness or loss of taste or smell, as per the judgement of the investigator
- Known or suspected malignancy, autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status or any factor that would predispose participants to develop infection (e.g., open skin lesions, recurrent issues related to poor dentition, perianal fissures, history of splenectomy, primary immunodeficiency)
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption in males \> 21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirits, 1.5 to 2 units = 125 mL glass of wine, depending on type)
- A confirmed positive alcohol breath test at screening or admission
- Current smokers and those who have smoked within the last 12 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission.
- Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
- Subjects with pregnant or lactating partners
- Subjects who do not have suitable veins for multiple venipunctures/cannulation as assessed by the investigator or delegate at screening
- Clinically significant abnormal clinical chemistry, hematology or urinalysis as judged by the investigator. Subjects with Gilbert's Syndrome are allowed.
- Confirmed positive drugs of abuse test result.
- Positive hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antibody results
- Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of \< 80 mL/min using the Cockcroft-Gault equation (Part 2 only)
- History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory, gastrointestinal (GI) disease, or neurological or psychiatric disorder as judged by the investigator
- Subject has a history or presence of any of the following (Part 2 only):
- Cytopenias
- Active GI disease requiring therapy
- Hepatic disease and/or alanine aminotransferase or aspartate aminotransferase \> upper limit of normal (ULN)
- Renal disease and/or serum creatinine \> ULN
- Other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
- Subjects with a history of cholecystectomy or gall stones (Part 2 only)
- Subject has QTcF intervals \>450 msec at screening or admission (Part 2 only)
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
- Donation of blood or plasma within the previous 3 months or loss \> 400 mL of blood
- Subjects who are taking or have taken any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g of paracetamol per day) in the 14 days prior to IMP administration, including proton pump inhibitors. Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as determined by the investigator.
- Failure to satisfy the investigator of fitness to participate for any other reason
Key Trial Info
Start Date :
October 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04735822
Start Date
October 26 2020
End Date
September 3 2021
Last Update
May 11 2022
Active Locations (1)
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1
Quotient Sciences
Nottingham, England, United Kingdom, NG11 6J5