NCT06397508

Relative Bioavailability and Effect of Food Study With AGMB-129 in Healthy Participants

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Agomab Spain S.L. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	AGMB-129	Each participant will receive 3 study interventions, 1 in each intervention period

Timeline

• Start date: 2024-04-02
• Primary completion: 2024-05-08
• Completion: 2024-05-13
• First posted: 2024-05-03
• Last updated: 2024-05-16

Locations

1 site across 1 country: Belgium