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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
Agomab Spain S.L.·Phase 1·ClinicalTrials.gov·drugCompleted
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Healthy Volunteers
Drug/Device/Intervention
AGMB-129
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Agomab Spain S.L.
Funder
Agomab Therapeutics NV
Location
Edegem, Belgium
Timeline & enrollment
Phase
Phase 1
Start date
Apr 02, 2024
End date
May 13, 2024
Enrollment
25 participants
Primary outcome

Cmax for AGMB-129,Cmax for MET-158,Cmax for MET-154,AUC0-t for AGMB-129,AUC0-t for MET-158,AUC0-t for MET-154,AUC0-∞ for AGMB-447,AUC0-∞ for MET-158,AUC0-∞ for MET-154

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.

ICD-10 classifications
Healthy person accompanying sick personRoutine general health check-up of armed forcesRoutine general health check-up of sports teamsRoutine general health check-up of inhabitants of institutions
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06397508
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06397508 through Pure Global AI's free database. This Phase 1 trial is sponsored by Agomab Spain S.L. and is currently Completed. The study focuses on Healthy Volunteers. Target enrollment is 25 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.