Single Ascending Dose PK, Oral Bioavailability and Food Effect Study in Healthy Male Volunteers (NLG2111)

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

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Indoximod HCL (F2) tablets; Other: Placebo; Drug: Indoximod HCL (F2) tablets; Drug: Indoximod base formulation

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Secaucus, New Jersey, United States, 07407
      • Frontage Clinical Services, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NewLink Genetics Corporation
• Investigators: Study Director: Eugene Kennedy, MD, NewLink Genetics Inc

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2018
• Primary Completion (Actual): March 5, 2018
• Study Completion (Actual): August 14, 2018

Study Registration Dates

• First Submitted: February 21, 2019
• First Submitted That Met QC Criteria: February 22, 2019
• First Posted (Actual): February 25, 2019

Study Record Updates

• Last Update Posted (Actual): May 28, 2020
• Last Update Submitted That Met QC Criteria: May 26, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Indoximod
• Additional Relevant MeSH Terms: Psychotropic Drugs; Antidepressive Agents; Antidepressive Agents, Second-Generation; Tryptophan
• Other Study ID Numbers: NLG2111

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No