The purpose of this study is to investigate the extent to which Lu AF11167 enters the bloodstream following tablet intake and the influence of food on uptake in healthy men and women
This study will be split into Part A and Part B. Part A will happen first and will look at new tablet formulations of the test medicine compared to a previously known formulation (reference tablet). The results from Part A of the study will be used to decide which formulation will be tested in Part B of the study. Part B of the study will look at the food effect, variability between participants, and absolute bioavailability of the test medicine i.e. how much of the test medicine is taken up by the body when dosed by mouth compared to when dosed once by injection directly into the vein. Safety and tolerability will be assessed throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Lu AF11167 - 2 mg modified release tablets (reference formulation), up to 5 prototype MR tablet formulations (test formulations)
single iv microdose administered as a 15 minutes infusion
Quotient
Nottingham, United Kingdom
Cmax of Lu AF11167
Maximum observed plasma concentration
Time frame: From 0 to 48 hours
AUC(0-inf) of Lu AF11167
Area under the plasma concentration time curve from zero to infinity
Time frame: From 0 to 48 hours
Relative bioavailability F(rel) of Lu AF11167
F(rel) is estimated as the dose normalized AUC(inf) for the test formulation relative to the reference formulation (part A only)
Time frame: From 0 to 48 hours
Absolute bioavailability F(abs) of Lu AF11167
F(abs) is estimated as the dose normalized AUC(inf) for the test formulation relative to the intravenous reference formulation (part B only)
Time frame: From 0 to 48 hours
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