A study in healthy male volunteers to look at how the test medicine ([Cyclohexane-U-14C]-MBS2320) is taken up, broken down and removed from the body when given by mouth
- Conditions
- Skin and Connective Tissue DiseasesPotential treatment of rheumatoid arthritis (RA) and idiopathic pulmonary fibrosis (IPF).
- Registration Number
- ISRCTN16794199
- Lead Sponsor
- Modern Biosciences Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 6
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)
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 <80 mL/min using the Cockcroft-Gault equation)
9. Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, whichever is longer
10. Subjects who report to have previously received MBS2320
11. Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017 shall participate in the study
12. Donation of blood or plasma or loss of greater than 400 mL of blood within the previous 3 months
13. 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
before IMP administration. Exceptions may apply, as determined by the investigator, if each of the following criteria are met: medication with a short half-life if the washout is such that no PD activity is expected by the time of dosing with IMP; and if the use of medication does not jeopardise the safety of the trial subject; and if
the use of medication is not considered to interfere with the objectives of the study
14. Subjects who have had any COVID-19 vaccines within 72 h before admission
15. History of any drug or alcohol abuse in the past 2 years
16. Regular alcohol consumption in males >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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 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.<br> 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.<br> 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.<br>
- Secondary Outcome Measures
Name Time Method