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

NCT03852446 | Completed Early Phase 1 FDA Drug

• 1 other identifier: NLG2111
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Indoximod

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Percentage of patients with adverse events

  up to 18 Days

• Percentage of patients with adverse events

  up to 36 Days

Study Arms (2)

Part 1: Single Ascending Dose

EXPERIMENTAL

Drug: Indoximod HCL (F2) tablets; Other: Placebo

Part 2: Bioavailability and Food Effect

EXPERIMENTAL

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

Drug: Indoximod base formulation; Drug: Indoximod HCL (F2) tablets

Interventions

Indoximod HCL (F2) tablets DRUG

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

Part 1: Single Ascending Dose

Indoximod base formulation DRUG

Single oral administration of 1200 mg

Part 2: Bioavailability and Food Effect

Placebo OTHER

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

Part 1: Single Ascending Dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• NewLink Genetics Corporation: lead

Study Sites (1)

Frontage Clinical Services, Inc.

Secaucus, New Jersey, 07407, United States

Location

MeSH Terms

Interventions

Tablets

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Eugene Kennedy, MD

  NewLink Genetics Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: February 25, 2019
• Study Start: March 5, 2018
• Primary Completion: March 5, 2018
• Study Completion: August 14, 2018
• Last Updated: May 28, 2020

Record last verified: 2020-05

Locations

US (1)