Taste Assessment and Relative Bioavailability Study of Belumosudil
Research type
Research Study
Full title
A Two-Part, Phase I Study Designed to Evaluate the Taste Profile of Novel Belumosudil Oral Suspensions (Part 1) and Assess the Relative Bioavailability of the Selected Belumosudil Oral Suspension Formulation Compared with Oral Tablet Reference (Part 2) in Healthy Male Subjects
IRAS ID
286962
Contact name
Olivier Schueller
Contact email
Sponsor organisation
Kadmon Corporation, LLC
Eudract number
2020-003446-37
Duration of Study in the UK
0 years, 7 months, 13 days
Research summary
Summary of Research
The Sponsor is developing the test medicine, belumosudil, for the potential treatment of fibrotic and autoimmune diseases. In fibrotic diseases, the bodies’ wound healing mechanism becomes overactive, causing damage and scarring to healthy tissue. In autoimmune diseases the bodies’ defence mechanism becomes overactive and attacks the bodies’ own cells.The study will try to evaluate the taste attributes of the test medicine, as well as determining the proportion of test medicine that enters the blood stream (relative bioavailability). It will try to determine how much of the test medicine enters the bloodstream over time (pharmacokinetics - PK) for the test medicine and its known metabolites (breakdown products), as well as the effect of food on the PK. Safety and tolerability will also be assessed.
The study will consist of two parts. In Part 1, up to 12 healthy male volunteers will receive six doses of the test medicine as an oral solution with different flavourings, in a sip and spit study. No test medicine is to be consumed. Volunteers will remain in the clinical unit from Day -1 until Day 1 (one hour post-final taste assessment). A taste questionnaire will be completed for each dose. There will be a follow-up phone call three-seven days post-final dose to ensure the volunteers’ wellbeing.
In Part 2, up to 18 healthy male volunteers will receive a 200 mg dose of the test medicine as a tablet in the fed state, or as an oral solution in either the fed or fasted state, over three periods. Volunteers will remain resident in the clinical unit from Day -1 until Day 10, covering all three periods, with a minimum washout periods of three days between each dose. There will be a follow-up phone call three-seven days post-final dose to ensure the volunteers’ wellbeing.
Summary of Results
Given that this is a phase 1 trial, very early in the product development stage, a lay summary of results has not been developed. A reference to a-reviewed medical journal article in English or summary results are planned to be posted on Sanofi.com website at https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbVnWipprRhVOlnVzS-2FXqlGdP-2Bk49kHh-2F3rXGihBI6M6r0SQWy-2Fnk0vrYVdnvPfks1QQH6oUjLcKWpjy3qb4GvM7VJ3-2Fwr-2F5Zg-2BX2fIRcAmVDud9JmQN8EA1N8fxU6Lmpyg-3D-3DGsY__E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YKEzV7gHeeKVxru5EA4KpLWnHejXoNTSE6Hzcmv9Xw-2FGQhWltV2-2FgVkVTqi0i4nxcTi8Jlgle1OPBFzfvIT8aZkLGQo7HVncEKdkZGTGXVKbGQ-2BjhICtPEFr2-2F-2BTu8S1NerUc9x1vYUAG64a-2F23JQbS1u2LgEVxEsbKA7YKKLP6Rg-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C7c7c5282df8941c766a708da8b64576e%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637975560321073941%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=feaNcDxe8RPNE2MPaFZUQIy7YiXlmaPm0rldIImBLdo%3D&reserved=0 in the future.REC name
Wales REC 2
REC reference
20/WA/0242
Date of REC Opinion
17 Sep 2020
REC opinion
Favourable Opinion