This 2-part study will assess the effect of formulation and food on the pharmacokinetics of Indoximod in healthy volunteers. Part 1 is an open-label, 3-period, 6-sequence study. Participants will receive single doses of Indoximod base or salt formulation, in the fasted or fed state. Part 2 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
INC Research/inVentiv Health
Toronto, Ontario, Canada
Area Under the Plasma Concentration-Time Curve
Part 1 (Food Effect)
Time frame: up to 20 Days
Pharmacokinetics: Serum concentrations (Cmax/Steady State)
Part 1 (Food Effect)
Time frame: up to 20 Days
Pharmacokinetics: Serum concentrations (Cmax/Steady State)
Part 2 (Single rising dose)
Time frame: up to 4 Days
Percentage of patients with adverse events
Part 1
Time frame: up to 34 Days
Percentage of patients with adverse events
Single rising dose
Time frame: up to 16 Days
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