A two-part open-label study to assess the absolute bioavailability of aramchol and the mass balance recovery, metabolite profile and identification of metabolite structures for \[14C\]-aramchol in healthy male subjects
A two-part open-label study to assess the absolute bioavailability of aramchol and the mass balance recovery, metabolite profile and identification of metabolite structures for \[14C\]-aramchol in healthy male subjects. A subject was considered evaluable in Part 1 if they provided PK samples for up to a minimum of 120 h after first investigational medicinal product (IMP) administration. A subject was considered evaluable in Part 2 if they provided biological samples for up to a minimum of 144 h after IMP administration or demonstrated \>90% mass balance recovery, or \<1% of the administered dose eliminated in excreta for 2 consecutive days, whichever was sooner.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Aramchol free acid (3β-arachidylamido-7α,12α-dihydroxy-5β-cholan-24-oic acid) is a synthetic small molecule, produced by conjugation of cholic acid (bile acid) and arachidic acid (saturated fatty acid) linked by a stable amide bond.
Quotient Sciences, Mere Way, Ruddington Fields, Ruddington, Nottingham, NG11 6JS, UK.
Nottingham, United Kingdom
Absolute bioavailability
Measure the AUC(0-inf) of orally and intravenously (IV) administered Aramchol
Time frame: 10 days
Mass balance recovery
Assess the mass balance recovery of total amounts of radioactivity excreted in urine and feces
Time frame: 10 days
Metabolite profiling
Assess the potential metabolites of Aramchol and determine their chemical structure in plasma, urine and fecal samples
Time frame: 10 days
Routes and rates of elimination
Determine the routes and rates of elimination of \[14C\]-Aramchol in excreta
Time frame: 10 days
Chemical structure of each metabolite accounting for more than 10%
Identify the chemical structure of each metabolite accounting for more than 10% by area under the curve (AUC) of circulating total radioactivity or 10% of the dose in urine and feces
Time frame: 10 days
PK- Area under the concentration-time curve (AUC)
Investigate the plasma Area under the concentration-time curve (AUC) of Aramchol
Time frame: 10 days
PK- Time of maximum observed concentration (Tmax)
Investigate the plasma Time of maximum observed concentration (Tmax) of Aramchol
Time frame: 10 days
PK- Maximum observed concentration (Cmax)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Investigate the plasma Maximum observed concentration (Cmax) of Aramchol
Time frame: 10 days
PK- Total body clearance (CL)
Investigate the Total body clearance (CL) of Aramchol
Time frame: 10 days
Safety- Adverse events
Assess and characterize the number of participants with adverse events
Time frame: 10 days
Safety- Clinical laboratory parameters
Assess and characterize the number of participants with clinically significant changes in clinical laboratory parameters
Time frame: 10 days