NCT06002555

Relative Bioavailability of a New Presentation of Apraglutide Versus the Reference Formulation

A Randomized Open-label, Single Dose, 3-Period, 6-Sequence, Cross-Over Trial With Washout Periods of at Least 14 Days to Investigate the Relative Bioavailability of Apraglutide in Dual Chamber Syringes Versus the Reference Formulation in Vials Following Subcutaneous Administrations in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: VectivBio AG · Industry
• Sex: All
• Age: 18 Years – 67 Years
• Healthy volunteers: Accepted

Summary

This trial compares the relative bioavailability of apraglutide in dual-chamber syringes (DCS) versus the reference formulation apraglutide in vials.

Detailed description

This is a single-center, open-label, randomized, three-period, and six-sequence cross-over trial with two washout periods of at least 14 days to compare the relative bioavailability of apraglutide using DCS versus the reference formulation in vials, following SC administrations in healthy male and female subjects. Following consent, subjects will undergo a Screening procedure to see if they are suitable to be enrolled in the trial. Screening may be performed up to 28 days prior to the first injection procedure. All eligible subjects will receive the following treatments in three separate treatment periods: * Treatment A: Single SC dose of 5 mg (400 µL) from DCS at a concentration of 12.5 mg/mL * Treatment B: Two concomitant single SC doses of 2.5 mg (400 µL each) of DCS at a concentration of 6.25 mg/mL * Treatment C: Single SC dose of 5 mg (200 µL) from vial at a concentration of 25 mg/mL of the current formulation-reference There will be a 14-day washout period between the first and second treatment periods and between the second and third treatment periods.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Apraglutide	Peptide analogue of GLP-2

Timeline

• Start date: 2023-05-23
• Primary completion: 2023-09-22
• Completion: 2023-09-22
• First posted: 2023-08-21
• Last updated: 2024-10-26

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study