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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-21

Study Completion Date

2018-04-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part 1: Bioavailability and Food Effect

Subjects will be randomized to receive the following 3 regimens in randomized sequence:

1. Single dose of Indoximod base formulation under fasting conditions
2. Single dose of Indoximod HCL (salt) formulation under fed conditions
3. Single dose of Indoximod HCL (salt) formulation under fasting conditions

Group Type EXPERIMENTAL