Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06397508
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2024-04-30
Brief Title:
Relative Bioavailability and Effect of Food Study With AGMB-129 in Healthy Participants
Sponsor:
Agomab Spain SL
Organization:
Agomab Therapeutics NV
Study Overview
Official Title:
A Randomized Open-Label 3-Period Single-Dose Cross-Over Study in Healthy Participants to Assess the Relative Bioavailability of AGMB-129 Given as Tablet Formulation Versus the Capsule Reference Formulation and to Assess the Effect of Food on Tablet Formulation
Status:
COMPLETED
Status Verified Date:
2024-05
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 is a single-center open-label single-dose randomized 3-period cross-over Phase 1 study in healthy adult participants to assess the BA of AGMB-129 tablet formulation relative to that of the reference capsule formulation and to assess the effect of food on the BA of a single oral dose of the AGMB-129 tablet formulation
A total of 24 participants will be enrolled Participants will be randomized to 1 of 6 intervention sequences Williams design according to a 6-sequence 3-period design In 3 sequential intervention periods each participant will receive 3 study interventions 1 in each intervention period The total duration of involvement for each participant screening through follow-up will be approximately 6 weeks
A total of 24 participants will be enrolled Participants will be randomized to 1 of 6 intervention sequences Williams design according to a 6-sequence 3-period design In 3 sequential intervention periods each participant will receive 3 study interventions 1 in each intervention period The total duration of involvement for each participant screening through follow-up will be approximately 6 weeks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None