Healthy Clinical Trial
Official title:
An Open Label, Single-dose, Single-period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of 14C-BC-3781 Administered Via the Intravenous or Oral Routes to Healthy Male Subjects
This is a single-centre, open-label, non-randomized, single dose study in healthy male subjects designed to assess mass balance recovery, metabolite profile and metabolite identification of radio-labeled BC-3781 administered via the intravenous or oral routes.
This is a single-centre, open-label, non-randomised, single dose study to assess the
pharmacokinetics, mass balance recovery, and metabolite profiling and identification
following administration of iv or oral 14C-BC-3781 to healthy male subjects It is planned to
enrol 2 cohorts of 5 subjects or 10 subjects in total. The active substance being
investigated in this study is radiolabeled lefamulin ([14C] BC 3781), present in the
investigational medicinal products (IMPs) as the acetate salt ([14C]-BC-3781.Ac).
Subjects assigned to Cohort A will receive a single IV administration of 14C-BC-3781
containing 150 mg BC-3781 and not more than (NMT) 4.3 MBq (117 µCi) 14C, administered as an
infusion over 60 min after a light breakfast.
Subjects assigned to Cohort B will receive a single oral administration of 14C-BC-3781
containing 600 mg BC-3781 and NMT 4.1 MBq (112 µCi) 14C, in the fasted state
;
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