Single Ascending Dose PK, Oral Bioavailability and Food Effect 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

EARLY_PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-05

Study Completion Date

2018-08-14

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 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.

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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: Single Ascending Dose

Group Type EXPERIMENTAL

Indoximod HCL (F2) tablets

Intervention Type DRUG

The doses will be ascending per cohort from 600 mg to 2400 mg

Placebo

Intervention Type OTHER

The matching placebo doses will be ascending per cohort from 1 to 4 tablets

Part 2: Bioavailability and Food Effect

1. Single dose of Indoximod HCL (F2) formulation under fasting conditions
2. Single dose of Indoximod HCL (F2) formulation under fed conditions
3. Single dose of Indoximod base formulation under fasting conditions

Group Type EXPERIMENTAL

Indoximod base formulation

Intervention Type DRUG

Single oral administration of 1200 mg

Indoximod HCL (F2) tablets

Intervention Type DRUG

Single oral administration of 1200 mg

Interventions

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Indoximod HCL (F2) tablets

The doses will be ascending per cohort from 600 mg to 2400 mg

Intervention Type DRUG

Indoximod base formulation

Single oral administration of 1200 mg

Intervention Type DRUG

Placebo

The matching placebo doses will be ascending per cohort from 1 to 4 tablets

Intervention Type OTHER

Indoximod HCL (F2) tablets

Single oral administration of 1200 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Non-smoker for at least 3 months
* BMI within 18 to 30 kg/m2
* Able to speak, read, and understand English or Spanish

Exclusion Criteria

* Clinically significant cardiac, pulmonary, hepatic or renal disease
* History of substance abuse or alcohol dependence within past 2 years
* Inability to fast for a minimum of 14 hours
* Inability to swallow large capsules/tablets
* Pending legal charges or is on probation

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes