Healthy volunteers Other
Conditions
Interventions
[14C]EIK1001 single intravenous dose, 30-minute infusion of 0.5 mg [14C]EIK1001 containing not more than (NMT) 2.9 MBq
Sponsors
Eikon Therapeutics, Inc.
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 for at least 6 months after dosing 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 as available at the time of the assessment 6. BMI of 18.0 kg/m2 to 35.0 kg/m2 as measured at screening 7. Weight =50 kg at screening 8. BSA of 1.50 m2 to 2.50 m2 as measured at screening (using Mosteller’s simplified calculation) 9. 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. Known allergy/intolerance to corticosteroids or antihistamines. 4. Known history of galactose intolerance, total lactase deficiency or glucose galactose malabsorption. 5. Known hypotensive reaction to any previous vaccine administration. 6. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or GI disease, neurological or psychiatric disorder, as judged by the investigator. 7. Subjects with diabetes mellitus. 8. Subjects with any predisposition for urinary retention (e.g. spinal cord lesion, prostatic hyperplasia) (as cetirizine hydrochloride may increase the risk of urinary retention). 9. Subjects who are at risk of convulsions (e.g. history of seizure activity outside of the setting of infantile febrile convulsions). 10. Subjects with a history of any autoimmune diseases (e.g. lupus, rheumatoid arthritis). 11. Subjects who do not have suitable veins for multiple venipunctures/cannulation as assessed by the investigator or delegate at screening. 12. Clinically significant abnormal clinical chemistry, hematology or urinalysis as judged by the investigator. Subjects with Gilbert’s Syndrome are not allowed. 13. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results. 14. Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CrCl) 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, depen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Route of excretion of [14C]EIK1001 radioactivity as measured by mass balance of total drug-related radioactivity in urine and feces. Mass balance of total drug-related radioactivity in urine and feces following dosage of [14C]EIK1001, as a percentage (%) of the dose administered. [Time Frame: Day 1 to Day 10] 2. Rate of excretion of [14C]EIK1001 radioactivity as measured by mass balance of total drug-related radioactivity in urine and feces. Mass balance of total drug-related radioactivity in urine and feces following dosage of [14C]EIK1001, as a percentage (%) of the dose administered. [Time Frame: Day 1 to Day 10] 3. PK of total radioactivity in whole blood and plasma following a single IV dose of [14C]EIK1001 For total radioactivity in whole blood and plasma, PK parameters include but are not limited to Cmax, Tmax, T1/2, AUC(0-last), AUC(0-inf), Vd, and CL. [Time Frame: Day 1 to Day 10] 4. PK of EIK1001 in plasma and urine following a single IV dose of [14C]EIK1001 in healthy subjects. PK parameters include but are not limited to Cmax, Tmax, T1/2, AUC(0-last), AUC(0-inf), Vd, CL, and CLr for EIK1001 in plasma, and Ae, CumAe, %Ae, and Cum%Ae for EIK1001 in urine. [Time Frame: Day 1 to Day 10] | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability of EIK1001 following a single IV dose of [14C]EIK1001 assessed using data including but not limited to vital signs, ECGs, clinical laboratory safety parameters, adverse event reporting, and physical examination [Time Frame: Day 1 to Day 10] | — |
Countries
England, United Kingdom
Contacts
Public ContactHarry Raftopoulos
Outcome results
None listed