This is a single site, open label, single dose, non-randomized study in healthy male and female subjects. The subjects will be evaluated for plasma, urine and feces levels of 14C-ABR-215050 during 21 days.
As a part of the pharmacokinetic documentation, the metabolism and mass balance of 14C-ABR-215050 will be studied in healthy subjects. Female healthy subjects are included in the study in case of expanding the indication to female forms of cancer. In this study a single dose of 1.0 mg of the study drug will be administered orally as a solution under fasted conditions. The absorption and safety profiles for the oral water solution will also be documented.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
6
1 mg ABR-215050
JJ Berzelius Clinical Research Center AB, Berzelius Science Park
Linköping, Sweden
To establish the metabolic pattern of ABR 215050
Time frame: 4 months
To study the mass balance and to determine the disposition and pathways of elimination of 14C-ABR-215050.
Time frame: 4 months
To follow the safety profile
Time frame: 4 months
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