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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03372239
Recruitment Status : Completed
First Posted : December 13, 2017
Last Update Posted : February 25, 2019
Information provided by (Responsible Party):
NewLink Genetics Corporation

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Indoximod base formulation Drug: Indoximod HCL (salt) formulation Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized Trial to Compare the Oral Bioavailability of Indoximod Salt and Base Formulations and the Effect of Food (Part 1) and to Evaluate the PK and Safety of Single Ascending Doses of Indoximod (Part 2) in Healthy Male Volunteers
Actual Study Start Date : November 21, 2017
Actual Primary Completion Date : January 25, 2018
Actual Study Completion Date : April 16, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sodium

Arm Intervention/treatment
Experimental: Part 1: Bioavailability and Food Effect

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
Specified dose on specified days

Drug: Indoximod HCL (salt) formulation
Specified dose on specified days

Other: Placebo
Specified dose on specified days

Experimental: Part 2: Single Ascending Dose Drug: Indoximod HCL (salt) formulation
Specified dose on specified days

Other: Placebo
Specified dose on specified days

Primary Outcome Measures :
  1. Area Under the Plasma Concentration-Time Curve [ Time Frame: up to 20 Days ]
    Part 1 (Food Effect)

  2. Pharmacokinetics: Serum concentrations (Cmax/Steady State) [ Time Frame: up to 20 Days ]
    Part 1 (Food Effect)

  3. Pharmacokinetics: Serum concentrations (Cmax/Steady State) [ Time Frame: up to 4 Days ]
    Part 2 (Single rising dose)

Secondary Outcome Measures :
  1. Percentage of patients with adverse events [ Time Frame: up to 34 Days ]
    Part 1

  2. Percentage of patients with adverse events [ Time Frame: up to 16 Days ]
    Single rising dose

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03372239

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Canada, Ontario
INC Research/inVentiv Health
Toronto, Ontario, Canada
Sponsors and Collaborators
NewLink Genetics Corporation
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Study Director: Eugene Kennedy, MD NewLink Genetics Inc

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Responsible Party: NewLink Genetics Corporation Identifier: NCT03372239     History of Changes
Other Study ID Numbers: NLG2108
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by NewLink Genetics Corporation:
Additional relevant MeSH terms:
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Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs