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

Early Phase 1CompletedNCT03852446

NewLink Genetics Corporation56 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

Indoximod HCL (F2) tabletsDRUG

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

Indoximod base formulationDRUG

Single oral administration of 1200 mg

PlaceboOTHER

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Frontage Clinical Services, Inc.

Secaucus, New Jersey, United States

Outcomes

Primary Outcomes

Area Under the Plasma Concentration-Time Curve

Part 2

Time frame: up to 20 Days

Pharmacokinetics: Serum concentrations (Cmax/Steady State)

Part 2

Time frame: up to 20 Days

Pharmacokinetics: Serum concentrations (Cmax/Steady State)

Part 1

Time frame: up to 4 Days

Secondary Outcomes

Percentage of patients with adverse events

Part 1

Time frame: up to 18 Days

Percentage of patients with adverse events

Part 2

Time frame: up to 36 Days

Data from ClinicalTrials.gov

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