Potential treatment of rheumatoid arthritis (RA) and idiopathic pulmonary fibrosis (IPF). Skin and Connective Tissue Diseases
Conditions
Interventions
There is a single treatment arm, and all 6 healthy male participants will receive the same treatment. There is no placebo. Participants will take the test medicine once. Participants will swallow a si
Sponsors
Modern Biosciences Ltd
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Must provide written informed consent 2. Must be willing and able to communicate and participate in the whole study 3. Aged 30 to 65 years inclusive at the time of signing informed consent 4. Must agree to adhere to the contraception requirements 5. Healthy males 6. Body mass index (BMI) of 18.0 to 35.0 kg/m² as measured at screening 7. Must have regular bowel movements (i.e. average stool production of =1 and =3 stools per day)
Exclusion criteria
Exclusion criteria: 1. Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients 2. History of any allergy to sulphonamides. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active 3. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or GI, neurological or psychiatric disorder, as judged by the investigator 4. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening 5. Evidence of current SARS-CoV-2 infection or history of contact with an individual known to have COVID-19 infection in the 14 days prior to IMP administration. 6. Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects with Gilbert’s Syndrome are allowed. Subjects with white cell count, lymphocyte count or neutrophil count less than the lower limit of normal 7. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results 8. Evidence of renal impairment at screening, as indicated by an estimated CLcr of 21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type) 17. A confirmed positive alcohol breath test at screening or admission 18. 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 19. Current users of e-cigarettes and nicot
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mass balance recovery of total radioactivity of excreta and the rates and routes of elimination of the test medicine from the body will be assessed by liquid scintillation counting from samples taken between Day 1 up to Day 10. 2. Identify breakdown products of the test medicine in excreta by liquid chromatography with radio detection and high resolution mass spectrometry, from samples taken from Day 1 up to Day 10. 3. Pharmacokinetics of the radiolabeled test medicine in plasma and whole blood will be assessed by taking blood samples for LC-MS/MS assay of the test medicine from Day 1 up to Day 10. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Identification of the chemical structure of each metabolite (breakdown product) accounting for more than 10% by AUC of plasma total radioactivity or accounting for 10% or more of the dose in excreta, by liquid chromatography with radio detection and high resolution mass spectrometry using samples taken between Day 1 up to Day 10 2. The pharmacokinetics of the test medicine and its main breakdown product (MBS2473) in plasma will be assessed by taking blood samples for LC-MS/MS assay of the test medicine, using samples taken between Day 1 up to Day 8. 3. Evaluation of whole blood:plasma concentration ratios for total radioactivity (to evaluate the extent of distribution of total radioactivity into blood cells), using samples taken between Day 1 up to Day 10 for LC-MS/MS assay of the test medicine. 4. Adverse events (to assess tolerability of the test medicine) will be collected by often asking volunteers how they are feeling, from the start of the trial until follow up. Other safety measures (including vital signs, ECGs and laboratory safety tests) will also be assessed by standard phase 1 unit monitoring, at screening, from Day –1 to discharge from the ward. | — |
Countries
England, United Kingdom
Contacts
Public ContactKerry Hylands
Outcome results
None listed