Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06002555
Status:
COMPLETED
Last Update Posted:
2024-01-09
First Post:
2023-07-11
Brief Title:
Relative Bioavailability of a New Presentation of Apraglutide Versus the Reference Formulation
Sponsor:
VectivBio AG
Organization:
VectivBio AG
Study Overview
Official Title:
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
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 125 mgmL
Treatment B Two concomitant single SC doses of 25 mg 400 µL each of DCS at a concentration of 625 mgmL
Treatment C Single SC dose of 5 mg 200 µL from vial at a concentration of 25 mgmL 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
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 125 mgmL
Treatment B Two concomitant single SC doses of 25 mg 400 µL each of DCS at a concentration of 625 mgmL
Treatment C Single SC dose of 5 mg 200 µL from vial at a concentration of 25 mgmL 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None