This is a Phase 1, investigator- and participant-blinded, placebo-controlled, randomized, crossover study to compare bioavailability of AQ280 following single oral doses of a capsule formulation versus a tablet for oral suspension formulation in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
9
AQ280 administered orally in capsule formulation.
AQ280 administered orally in tablet for oral suspension formulation.
Placebo administered orally in capsule formulation.
Clinical Research Site
Madison, Wisconsin, United States
Relative Bioavailability (Frel)
Time frame: Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-∞)
Time frame: Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-tlast)
Time frame: Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
Maximum observed concentration (Cmax)
Time frame: Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
Time of the maximum observed concentration (Tmax)
Time frame: Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
Apparent terminal elimination half-life (t1/2)
Time frame: Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
Apparent total clearance (CL/F)
Time frame: Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
Apparent volume of distribution during the terminal phase (Vz/F)
Time frame: Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
Incidence and severity of adverse events
Time frame: From screening up to end of study (approximately 7 weeks)
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Placebo administered orally in tablet for oral suspension formulation.
Incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results
Time frame: Screening, Day -1 and up to 48 hours post dose (up to end of study - approximately 7 weeks)
Number of participants with abnormal electrocardiograms
QTcF interval of \>500 msec or change from baseline (Day 1, predose) \>60 msec
Time frame: Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
Number of participants with clinically significant abnormalities in vital signs - blood pressure (systolic in mm Hg)
Time frame: Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
Number of participants with clinically significant abnormalities in vital signs - blood pressure (diastolic in mm Hg)
Time frame: Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
Number of participants with clinically significant abnormalities in vital signs - pulse rate (beats per minute)
Time frame: Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
Number of participants with clinically significant abnormalities in vital signs - oral body temperature (°C)
Time frame: Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
Incidence of abnormal physical examinations
Time frame: From screening up to end of study (approximately 7 weeks)