A phase 1 healthy volunteer study to assess the excretion and metabolism as well as the absolute bioavailability of oral JMKX003142. The study will be conducted in two parts: Part 1 to assess the mass balance of JMKX003142 using orally administered radiolabelled JMKX003142; part 2 will assess the absolute bioavailability using JMKX003142 and radiolabelled JMKX003142 as intravenous and oral forms
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Participants will receive oral \[14C\]JMKX003142
Participants will receive oral JMKX003142
Participants will receive IV \[14C\] JMKX003142
Mass balance of JMKX003142
Total recovery of radioactivity in urine and faeces following a single oral dose of \[14C\]-JMKX003142 (expressed as a percentage of the total radioactive dose administered)
Time frame: up to 15 days (until >90% of dose is recovered)
Absolute bioavailability of JMKX003142 in plasma
Absolute bioavailability is calculated from the AUCs of iv and oral administration
Time frame: 96 hours
Part1: Maximum Concentration (Cmax) of JMKX003142 in Plasma
Time frame: Day 1 to day 15 (depending on recovery of dose)
Part1: Time to Reach Maximum Concentration (tmax) of JMKX003142 in Plasma
Time frame: Day 1 to day 15 (depending on recovery of dose)
Part1: Apparent Terminal Half-Life (t1/2) Of JMKX003142
Time frame: Day 1 to day 15 (depending on recovery of dose)
Part1: Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf) of JMKX003142 in Plasma
Time frame: Day 1 to day 15 (depending on recovery of dose)
Frequency and severity of Participants With Adverse Events (AEs)
Time frame: Up to Day 30
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.