Single Ascending Dose PK, Oral Bioavailability and Food Effect Study in Healthy Male Volunteers
Status:
Completed
Trial end date:
2018-08-14
Target enrollment:
Participant gender:
Summary
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.