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

NCT03372239 | Completed Phase 1 FDA Drug

• 1 other identifier: NLG2108
• Study Type: interventional
• Target: 48
• 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 an open-label, 3-period, 6-sequence study. Participants will receive single doses of Indoximod base or salt formulation, in the fasted or fed state. Part 2 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.

Conditions

Healthy

Keywords

Indoximod

Outcome Measures

Primary Outcomes (3)

• Area Under the Plasma Concentration-Time Curve

  Part 1 (Food Effect)

  up to 20 Days

• Pharmacokinetics: Serum concentrations (Cmax/Steady State)

  Part 1 (Food Effect)

  up to 20 Days

• Pharmacokinetics: Serum concentrations (Cmax/Steady State)

  Part 2 (Single rising dose)

  up to 4 Days

Secondary Outcomes (2)

• Percentage of patients with adverse events

  up to 34 Days

• Percentage of patients with adverse events

  up to 16 Days

Study Arms (2)

Part 1: Bioavailability and Food Effect

EXPERIMENTAL

Subjects will be randomized to receive the following 3 regimens in randomized sequence: 1. Single dose of Indoximod base formulation under fasting conditions 2. Single dose of Indoximod HCL (salt) formulation under fed conditions 3. Single dose of Indoximod HCL (salt) formulation under fasting conditions

Drug: Indoximod base formulation; Drug: Indoximod HCL (salt) formulation; Other: Placebo

Part 2: Single Ascending Dose

EXPERIMENTAL

Drug: Indoximod HCL (salt) formulation; Other: Placebo

Interventions

Indoximod base formulation DRUG

Specified dose on specified days

Part 1: Bioavailability and Food Effect

Indoximod HCL (salt) formulation DRUG

Specified dose on specified days

Part 1: Bioavailability and Food Effect; Part 2: Single Ascending Dose

Placebo OTHER

Specified dose on specified days

Part 1: Bioavailability and Food Effect; Part 2: Single Ascending Dose

Eligibility Criteria

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

You may qualify if:

• Healthy male subjects 18 to 55 years of age, inclusive.
• Body mass index (BMI) of 18.0 to 30.0 kg/m2, and a minimum weight of 50.0 kg.
• Non-smoker for at least 3 months prior to Screening.
• Male subjects with female sexual partners of childbearing potential must be using and willing to continue using medically acceptable contraception
• Signed and dated written informed consent

You may not qualify if:

• History or presence of any clinically significant abnormality, illness, or disease which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or influence the validity of the results of the study.
• Subjects with autoimmune conditions, inflammatory bowel disease, rheumatoid arthritis, and/or subjects who have undergone an organ transplant.
• Self-reported history of substance or alcohol dependence within the past 2 years, and/or has ever participated or plans to participate in a substance or alcohol rehabilitation program to treat their substance or alcohol dependence.
• Any medical/surgical procedure or trauma within 4 weeks of the first study drug administration or planned within 1 month of study completion.
• Positive urine drug screen.
• Positive breath alcohol test.
• Evidence of clinically significant hepatic or renal impairment
• Inability to fast for a minimum of 14 hours.
• Inability to swallow large capsules/tablets.
• Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
• Donation or loss of more than 500 mL whole blood within 1 month preceding entry into the Treatment phase and throughout the study.
• Difficulty with venous access or unsuitable or unwilling to undergo catheter insertion.
• History of severe allergic reaction (including anaphylaxis) to any substance, or previous status asthmaticus.
• Treatment with an investigational drug within 5 times the elimination half-life, if known (eg, a marketed product), or within 30 days (if the elimination half-life is unknown) prior to first drug administration or is concurrently enrolled in any research judged not to be scientifically or medically compatible with this study.

Sponsors & Collaborators

• NewLink Genetics Corporation: lead

Study Sites (1)

INC Research/inVentiv Health

Toronto, Ontario, Canada

Location

MeSH Terms

Interventions

Salts; Dosage Forms

Intervention Hierarchy (Ancestors)

Inorganic Chemicals; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Eugene Kennedy, MD

  NewLink Genetics Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: 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: December 10, 2017
• First Posted: December 13, 2017
• Study Start: November 21, 2017
• Primary Completion: January 25, 2018
• Study Completion: April 16, 2018
• Last Updated: May 28, 2020

Record last verified: 2020-05

Locations

CA (1)