The purpose of this study is to assess distribution, metabolism, and excretion of radio-labelled AZD9742 administered as a 2-hour infusion to healthy male volunteers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
1000 mg intravenous over 2 hours
Research Site
Overland Park, Kansas, United States
To characterize the distribution and elimination of AZD9742 and total 14C radioactivity in healthy volunteers following a single 1000 mg intravenous (IV) dose of [14C]-AZD9742 administered as a 2-hour infusion.
12 hours pre dose to 168 hours post dose of the treatment period if the patient meets discharge criteria. If the patient does not meet discharge criteria after 168 hours post dose, additional 24 hour collections up to 7 additional days or until discharge criteria are met, whichever occurs first.
Time frame: Range of 12 hours pre dose to 168 hours post dose
To evaluate the excretion of 14C (mass balance) in urine and feces after a single 1000 mg intravenous (IV) dose of [14C]-AZD9742 administered as a 2-hour infusion.
12 hours pre dose to 168 hours post dose of the treatment period if the patient meets discharge criteria. If the patient does not meet discharge criteria after 168 hours post dose, additional 24 hour collections up to 7 additional days or until discharge criteria are met, whichever occurs first.
Time frame: Range of 12 hours pre dose to 168 hours post dose
Safety of AZD9742 after a single intravenous 14C administration of AZD9742, by assessing a panel of measures: Adverse Events, vital sign evaluations, physical examination, electrocardiograms (ECG) and clinical laboratory parameters.
To explore and establish the metabolite profiles in plasma and excreta; where possible the identity of metabolites will be determined.
Time frame: Immediately prior to the end of the infusion, 4 hours after the end of the infusion and 24 hours after the start of the infusion.
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