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

Study Overview
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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.

Official Title
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A Phase 1, Randomized Trial to Evaluate the Pharmacokinetics and Safety of Single Ascending Doses of Indoximod HCl (F2) Tablets (Part 1) and to Compare the Oral Bioavailability of Indoximod Cl (F2) Tablets and Indoximod Free Base Capsule Formulations and the Effect of Food (Part 2) in Healthy Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Indoximod HCL (F2) tablets
* Drug: Indoximod base formulation
* Other: Placebo
* Drug: Indoximod HCL (F2) tablets


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1: Single Ascending Dose<br> | Drug: Indoximod HCL (F2) tablets<br>* The doses will be ascending per cohort from 600 mg to 2400 mg<br>Other: Placebo<br>* The matching placebo doses will be ascending per cohort from 1 to 4 tablets<br>|
| Experimental: Part 2: Bioavailability and Food Effect<br>Single dose of Indoximod HCL (F2) formulation under fasting conditions Single dose of Indoximod HCL (F2) formulation under fed conditions Single dose of Indoximod base formulation under fasting conditions | Drug: Indoximod base formulation<br>* Single oral administration of 1200 mg<br>Drug: Indoximod HCL (F2) tablets<br>* Single oral administration of 1200 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Plasma Concentration-Time Curve | Part 2 | up to 20 Days | 
| Pharmacokinetics: Serum concentrations (Cmax/Steady State) | Part 2 | up to 20 Days | 
| Pharmacokinetics: Serum concentrations (Cmax/Steady State) | Part 1 | up to 4 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with adverse events | Part 1 | up to 18 Days | 
| Percentage of patients with adverse events | Part 2 | up to 36 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Indoximod