This is a single-dose, fasting and non-fasting, open-label, randomized, three-regimen, parallel group study in 42 subjects
This is a randomized, open label, single dose, parallel group study consisting of 3 groups of 14 subjects each. Subjects will be confined for 3 days followed by outpatient assessments until Day 21. Blood samples for assessment of DSM265 plasma concentrations will be collected for 480 hours after dosing. This study will compare the relative bioavailability of the oral DSM265 50% spray dried dispersion (SDD) granules with that of a reference 25% SDD powder for suspension formulation, and evaluate the effect of food on the DSM265 50% SDD granules
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
11
Single oral dose 400 mg
Single oral dose 400 mg
AbbVie Clinical Pharmacology Research Unit (ACPRU)
Grayslake, Illinois, United States
DSM265 maximum observed plasma concentration (Cmax)
Time frame: Pre-dose and post-dose at 0.5, 1, 2, 4, 6, 8, 12, 24, 72, 120, 168, 216, 312 and 480 hours
DSM265 time to Cmax (Tmax)
Time frame: Pre-dose and post-dose at 0.5, 1, 2, 4, 6, 8, 12, 24, 72, 120, 168, 216, 312 and 480 hours
DSM265 observed concentration at 168 hours after dosing (C168)
Time frame: Pre-dose and post-dose at 0.5, 1, 2, 4, 6, 8, 12, 24, 72, 120, 168, 216, 312 and 480 hours
DSM265 apparent terminal phase elimination rate constant (β)
Time frame: Pre-dose and post-dose at 0.5, 1, 2, 4, 6, 8, 12, 24, 72, 120, 168, 216, 312 and 480 hours
DSM265 terminal elimination half-life (t1/2)
Time frame: Pre-dose and post-dose at 0.5, 1, 2, 4, 6, 8, 12, 24, 72, 120, 168, 216, 312 and 480 hours
DSM265 area under the plasma concentration-time curve from time 0 to the time of the last measurable concentration (AUCt)
Time frame: Pre-dose and post-dose at 0.5, 1, 2, 4, 6, 8, 12, 24, 72, 120, 168, 216, 312 and 480 hours
DSM265 area under the plasma concentration-time curve from time 0 to infinity (AUC∞)
Time frame: Pre-dose and post-dose at 0.5, 1, 2, 4, 6, 8, 12, 24, 72, 120, 168, 216, 312 and 480 hours
safety evaluations
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Time frame: Pre-dose and Days 1, 2, 4, 6, 8, 10, 14, and 21
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