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

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.

Timeline

Start

2018-03-05

Primary completion

2018-03-05

Completion

2018-08-14

Drugs

Indications

No indication recorded.