Single Ascending Dose PK, Oral Bioavailability and Food Effect Study in Healthy Male Volunteers

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2018
This 2-part study will assess the effect of formulation and food on the pharmacokinetics of Indoximod in healthy volunteers. Part 1 is a randomized single ascending dose study of indoximod salt formulation to characterize the PK profile and determine the safety and tolerability of each dose in healthy male volunteers. Part 2 is an open-label, randomized, 3-period, 3-way crossover study. Participants will receive single doses of Indoximod base or salt formulation, in the fasted or fed state.
Epistemonikos ID: ceca8659b798c7c8f0f64145878b23865c5d3a1f
First added on: May 22, 2024