A phase 1 healthy volunteer study to assess the mass balance, elimination, and metabolic profile of CRN00808. The study will be conducted in 2 parts: Part A, to characterize the absorption, distribution, metabolism, excretion, and mass balance of orally administered radio-labeled CRN00808; Part B, to determine the absolute bioavailability of CRN00808 administered using CRN00808 and radio-labeled CRN00808 as intravenous and oral forms.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Investigational drug
Investigational drug
PRA Health Sciences
Groningen, Netherlands
Mass balance of CRN00808
Total radioactivity in urine and feces following a single oral dose \[14C\]-CRN00808 (expressed as a percentage of the total radioactive dose administered)
Time frame: Up to 21 days (until >90% of dose is recovered)
Absolute bioavailability of CRN00808
Absolute bioavailability is calculated from the areas under the curve of intravenous and oral administration
Time frame: 5 days
Pharmacokinetics (AUC)
Assessment of the plasma area under the curve of CRN00808 and \[14C\]-CRN00808
Time frame: Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7
Pharmacokinetics (t1/2)
Assessment of the total elimination half-life of CRN00808 and \[14C\]-CRN00808
Time frame: Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7
Pharmacokinetics (Tmax)
Assessment of Time to attain maximum observed plasma concentration of CRN00808 and \[14C\]-CRN00808
Time frame: Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7
Pharmacokinetics (CL)
Assessment of the clearance of CRN00808 (Part B only)
Time frame: Day 1 through to Day 7
Pharmacokinetics (CL/F)
Assessment of Apparent oral clearance of CRN00808
Time frame: Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pharmacokinetics (Vz)
Assessment of Volume of distribution at terminal phase (Part B only)
Time frame: Day 1 through to Day 7
Pharmacokinetics (Vz/F)
Assessment of Apparent volume of distribution at terminal phase
Time frame: Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7