Relative Bioavailability and Effect of Food Study With AGMB-129 in Healthy Participants - Trial NCT06397508
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.
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Study Focus
Sponsor & Location
Agomab Spain S.L.
Agomab Therapeutics NV
Timeline & Enrollment
Phase 1
Apr 02, 2024
May 13, 2024
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
Data Source
ClinicalTrials.gov
NCT06397508
Non-Device Trial