Clincosm LogoSign in Get a demo

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

Sponsor
NewLink Genetics Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT03372239
Collaborator
(none)
48
Enrollment
1
Location
2
Arms
4.8
Actual Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Indoximod base formulation
  • Drug: Indoximod HCL (salt) formulation
  • Other: Placebo
 Phase 1

Study Design

Study Type:
Interventional
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 :
Nov 21, 2017
Actual Primary Completion Date :
Jan 25, 2018
Actual Study Completion Date :
Apr 16, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

  1. Area Under the Plasma Concentration-Time Curve [up to 20 Days]

    Part 1 (Food Effect)

  2. Pharmacokinetics: Serum concentrations (Cmax/Steady State) [up to 20 Days]

    Part 1 (Food Effect)

  3. Pharmacokinetics: Serum concentrations (Cmax/Steady State) [up to 4 Days]

    Part 2 (Single rising dose)

Secondary Outcome Measures

  1. Percentage of patients with adverse events [up to 34 Days]

    Part 1

  2. Percentage of patients with adverse events [up to 16 Days]

    Single rising dose

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 INC Research/inVentiv Health Toronto Ontario Canada

Sponsors and Collaborators

  • NewLink Genetics Corporation

Investigators

  • Study Director: Eugene Kennedy, MD, NewLink Genetics Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NewLink Genetics Corporation
ClinicalTrials.gov Identifier:
NCT03372239
Other Study ID Numbers:
  • NLG2108
First Posted:
Dec 13, 2017
Last Update Posted:
May 28, 2020
Last Verified:
May 1, 2020
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
Indoximod
Additional relevant MeSH terms:
Tryptophan

Study Results

No Results Posted as of May 28, 2020