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
Ratio of AUC0-Inf for AQ280 Capsule vs Oral Suspension
Ratio values were derived based on values for AUC0-Inf of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation.
Time frame: Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
Ratio of Cmax for AQ280 Capsule vs Oral Suspension
Ratio values were derived based on values for Cmax of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation.
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-∞)
AUC0-∞ of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
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)
AUC0-tlast of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
Time frame: Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
Maximum Observed Concentration (Cmax)
Cmax of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
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)
Tmax of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
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Placebo administered orally in tablet for oral suspension formulation.
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)
T1/2 of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
Time frame: Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
Apparent Total Clearance (CL/F)
CL/F of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
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)
Vz/F of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
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
Incidence and severity of adverse events to assess the safety and tolerability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
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 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)
Number of participants with clinically significant abnormalities in vital signs - blood pressure (systolic in mm Hg) to assess the safety and tolerability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
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)
Number of participants with clinically significant abnormalities in vital signs - blood pressure (diastolic in mm Hg) to assess the safety and tolerability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
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)
Number of participants with clinically significant abnormalities in vital signs - pulse rate (beats per minute) to assess the safety and tolerability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
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)
Number of participants with clinically significant abnormalities in vital signs - oral body temperature (°C) to assess the safety and tolerability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
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
Incidence of abnormal physical examinations to assess the safety and tolerability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation. Any clinically significant findings observed during physical examinations following dose administration were reported as adverse events.
Time frame: From screening up to end of study (approximately 7 weeks)