Clincosm LogoSign in Get a demo

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

Sponsor
NewLink Genetics Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT03852446
Collaborator
(none)
56
Enrollment
1
Location
2
Arms
5.3
Actual Duration (Months)
10.5
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 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Indoximod HCL (F2) tablets
  • Drug: Indoximod base formulation
  • Other: Placebo
  • Drug: Indoximod HCL (F2) tablets
 Early Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
56 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 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
Actual Study Start Date :
Mar 5, 2018
Actual Primary Completion Date :
Mar 5, 2018
Actual Study Completion Date :
Aug 14, 2018

Arms and Interventions

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
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 base formulation
Single oral administration of 1200 mg

Drug: Indoximod HCL (F2) tablets
Single oral administration of 1200 mg

Outcome Measures

Primary Outcome Measures

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

    Part 2

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

    Part 2

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

    Part 1

Secondary Outcome Measures

  1. Percentage of patients with adverse events [up to 18 Days]

    Part 1

  2. Percentage of patients with adverse events [up to 36 Days]

    Part 2

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Frontage Clinical Services, Inc. Secaucus New Jersey United States 07407

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:
NCT03852446
Other Study ID Numbers:
  • NLG2111
First Posted:
Feb 25, 2019
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
Keywords provided by NewLink Genetics Corporation
Indoximod
Additional relevant MeSH terms:
Tryptophan

Study Results

No Results Posted as of May 28, 2020