Comparing the Extent to Which AQ280 is Made Available in the Body After Single Oral Doses of a Capsule Formulation Versus a Tablet for Oral Suspension Formulation

Not Applicable

Active, not recruiting

• Conditions: Eosinophilic Esophagitis
• Interventions: Drug: Placebo Capsule; Drug: AQ280 Capsule; Drug: Placebo Tablet for Oral Suspension; Drug: AQ280 Tablet for Oral Suspension

• Registration Number: NCT07093008
• Lead Sponsor: AQILION AB

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-06-13
• Status Verified: 2025-07
• Study First Submitted: 2025-07-04
• Primary Completion: 2025-07-16
• Study Completion: 2025-07-22
• Study First Submitted QC: 2025-07-29
• Last Update Submitted: 2025-07-29
• Study First Posted: 2025-07-30
• Last Update Posted: 2025-07-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention Sequence 1	Placebo Capsule	Treatment Period 1: Placebo Capsule will be administered orally. Treatment Period 2: Placebo Tablet for Oral Suspension will be administered orally.
Intervention Sequence 1	Placebo Tablet for Oral Suspension	Treatment Period 1: Placebo Capsule will be administered orally. Treatment Period 2: Placebo Tablet for Oral Suspension will be administered orally.
Intervention Sequence 2	Placebo Capsule	Treatment Period 1: Placebo Tablet for Oral Suspension will be administered orally. Treatment Period 2: Placebo Capsule will be administered orally.
Intervention Sequence 3	AQ280 Tablet for Oral Suspension	Treatment Period 1: AQ280 Capsule will be administered orally. Treatment Period 2: AQ280 Tablet for Oral Suspension will be administered orally.
Intervention Sequence 4	AQ280 Capsule	Treatment Period 1: AQ280 Tablet for Oral Suspension will be administered orally. Treatment Period 2: AQ280 Capsule will be administered orally.
Intervention Sequence 2	Placebo Tablet for Oral Suspension	Treatment Period 1: Placebo Tablet for Oral Suspension will be administered orally. Treatment Period 2: Placebo Capsule will be administered orally.
Intervention Sequence 3	AQ280 Capsule	Treatment Period 1: AQ280 Capsule will be administered orally. Treatment Period 2: AQ280 Tablet for Oral Suspension will be administered orally.
Intervention Sequence 4	AQ280 Tablet for Oral Suspension	Treatment Period 1: AQ280 Tablet for Oral Suspension will be administered orally. Treatment Period 2: AQ280 Capsule will be administered orally.

Primary Outcome Measures

Name	Time	Method
Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-tlast)	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-∞)	Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
Apparent terminal elimination half-life (t1/2)	Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
Apparent total clearance (CL/F)	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)	Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
Relative Bioavailability (Frel)	Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
Maximum observed concentration (Cmax)	Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
Time of the maximum observed concentration (Tmax)	Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)

Secondary Outcome Measures

Name	Time	Method
Incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results	Screening, Day -1 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)	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)	Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
Incidence and severity of adverse events	From screening up to end of study (approximately 7 weeks)
Number of participants with abnormal electrocardiograms	Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)	QTcF interval of \>500 msec or change from baseline (Day 1, predose) \>60 msec
Number of participants with clinically significant abnormalities in vital signs - blood pressure (diastolic in mm Hg)	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)	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	From screening up to end of study (approximately 7 weeks)

Trial Locations

Locations (1)

Clinical Research Site; 🇺🇸 Madison, Wisconsin, United States