This trial is in healthy volunteers Other
Conditions
Interventions
This is a single-period, single-dose, non-randomised, open-label study. We’ll give healthy male volunteers a single dose of test medicine to find out how the body breaks down and gets rid of the test
Sponsors
Latigo Biotherapeutics, Inc.
Eligibility
Sex/Gender
Male
Age
30 Years to 65 Years
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 defined in the clinical protocol 5. Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs, 12-lead ECG, and laboratory safety tests without any clinically significant abnormalities. Urinalysis, ECGs and vital signs to be re-checked at admission/pre-dose 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. 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 particularly gastrointestinal (GI) disease, especially peptic ulceration, GI bleeding, ulcerative colitis, Crohn’s Disease or Irritable Bowel Syndrome, neurological or psychiatric disorder, as judged by the investigator 4. History of GI surgery (with the exception of appendectomy or hernia repair unless it was performed within the previous 12 months) 5. Acute diarrhoea or constipation in the 7 days before the predicted Day 1. If screening occurs >7 days before Day 1, this criterion will be determined on Day 1. Diarrhoea will be defined as the passage of liquid faeces and/or a stool frequency of greater than three times per day. Constipation will be defined as a failure to open the bowels more frequently than every other day. 6. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening 7. Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects with Gilbert’s Syndrome are not allowed 8. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results 9. Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of 450 msec 11. 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 12. 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 13. Donation of blood or plasma within the previous 3 months or loss of greater than 400 ml of blood 14. 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 pharmacodynamic 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. 15. Subjects who have had a vaccine within 15 days before IMP administration 16. History of any drug or alcohol abuse in the past 2 years 17. 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) 18. A confirmed positive alcohol breath test at screening or administration 19. Current smokers and those who have smoked within the last 12 months 20. Current users of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total radioactivity (TR) measured using urine and faecal samples collected from Day 1 until mass balance criteria have been met | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Metabolite profiling and identification (ID) measured using urine and faecal samples taken for from Day 1 until mass balance criteria have met 2. TR and PK and metabolite profiling and ID measured using plasma samples taken from Day 1 up to discharge from the clinical unit 3. TR measured using whole blood from Day 1 up to discharge from the clinical unit 4. Safety and tolerability measured using assessment of adverse events (AEs), physical examinations and change from baseline for vital signs, ECGs, and laboratory safety tests from screening up to discharge from the study | — |
Countries
England, United Kingdom
Contacts
Public ContactNeil Singla
Outcome results
None listed