This phase I study is to assess the mass balance recovery after a single oral dose of \[14C\]-AK0529 in healthy male subjects.
This is a single centre, single-dose, non-randomised, open label study. The primary objectives of this study are to assess the mass balance recovery and provide biosamples for metabolite profiling and structural identification after a single oral dose of \[14C\]-AK0529 in healthy male subjects. 7 subjects will be recruited to receive a single oral administration of a solution containing 300 mg AK0529. The total duration of the study will be approximately 6 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
A solution containing 300 mg radiolabelled AK0529.
Quotient Clinical
Nottingham, United Kingdom
Amount excreted (Ae)
The amount of total radioactivity eliminated.
Time frame: At approximately 6 weeks
Percentage of the administered dose (%Ae)
The amount of total radioactivity eliminated expressed as a percentage of the dose administered.
Time frame: At approximately 6 weeks
Cumulative recovery (CumAe)
The cumulative amount of total radioactivity eliminated.
Time frame: At approximately 6 weeks
Percentage of cumulative recovery of the administered dose (Cum%Ae)
The cumulative amount of total radioactivity eliminated expressed as a percentage of the dose administered.
Time frame: At approximately 6 weeks
Percentage of Subjects with Adverse Events (AEs)
An adverse event can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Time frame: From baseline up to approximately 6 weeks
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