clinical trial · NCT07254286
Food Effect Study in Healthy Volunteers
Healthy VolunteerIcovamenibIcovamenib HPMC
brief summary
A phase 1 open-label, randomized, crossover food effect and formulation assessment for icovamenib capsule in healthy volunteers.
started
Sep 11, 2025
primary completion
Jan 14, 2026
completion
Jan 14, 2026
last updated
Feb 11, 2026
detailed description
This is a phase 1, open-label, randomized, single dose, up to 7-way crossover study. It is planned to enroll 60 healthy male and female subjects. Subjects will be randomized to receive one of 5 sequences, with N=12 per sequence. Subjects will be dosed in a single residency period. This study is designed to evaluate the effect of meal time and fat content of food on the PK and safety of the icovamenib capsule and the icovamenib hydroxypropyl methylcellulose (HPMC) capsule formulation.
official title
A Phase 1 Open-Label, Randomized, Crossover Food Effect and Formulation Assessment for Icovamenib Capsule in Healthy Volunteers
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol