drugset / Trial / NCT06397508

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

NCT06397508 ↗

Phase 1 Completed 25 enrolled Agomab Therapeutics NV
RandomizedSequentialOpen-labelBasic science

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.

Timeline

Start
2024-04-02
Primary completion
2024-05-08
Completion
2024-05-13

Drugs

EvaluationDrugModalityDoseRoute
Subject AGMB-129 Unknown — Oral

Indications

No indication recorded.