The primary objectives of the study are to assess the mass balance recovery after a single dose of carbon-14 \[14C\]-A4250 as a capsule and to provide plasma, urine and faecal samples for metabolite profiling and structural identification in healthy male subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Each subject will receive a single administration of 3 mg \[14C\]-A4250 capsule for oral administration containing not more than 4.3 MBq (116 μCi), in the fasted state.
Quotient Clinical
Ruddington, Nottingham, United Kingdom
To assess mass balance recovery of total radioactivity in urine
Amount excreted (Ae) and Ae as a percentage of the administered dose (% Ae), cumulative recovery (CumAe) and cumulative recovery expressed as a percentage of the dose (Cum%Ae)
Time frame: Between pre-dose (admission to 0 hour) and post dose (ending on morning of discharge (up to day 10 depending on if mass balance cumulative recovery >90% or <1% of dose has been collected))
To assess mass balance recovery of total radioactivity in faeces
Amount excreted (Ae) and Ae as a percentage of the administered dose (% Ae), cumulative recovery (CumAe) and cumulative recovery expressed as a percentage of the dose (Cum%Ae)
Time frame: Between pre-dose (admission to 0 hour) and post dose (ending on the morning of discharge (up to day 10 depending on if mass balance cumulative recovery >90% or <1% of dose has been collected))
Metabolite profiling of A4250 of plasma using liquid-chromatography-radio-detection with subsequent mass spectrometry as appropriate
Identification of the chemical structure of each metabolite accounting for greater than 10% of circulating radioactivity in plasma
Time frame: Between pre-dose and up to 48 hours post dose
Metabolite profiling of A4250 of urine using liquid-chromatography-radio-detection with subsequent mass spectrometry as appropriate
Identification of the chemical structure of each metabolite accounting for greater than 10% of the dose in urine
Time frame: Between pre-dose (admission to 0 hour) and post dose (ending on the morning of discharge (up to day 10 depending on if mass balance cumulative recovery >90% or <1% of dose has been collected))
Metabolite profiling of A4250 of faeces using liquid-chromatography-radio-detection with subsequent mass spectrometry as appropriate
Identification of the chemical structure of each metabolite accounting for greater than 10% of the dose in faeces
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Time frame: Between pre-dose (admission to 0 hour) and post dose (ending on the morning of discharge (up to day 10 depending on if mass balance cumulative recovery >90% or <1% of dose has been collected))