MedTrace Logo

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

NCT03372239 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2020-05-28

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • NewLink Genetics Corporation

    lead INDUSTRY

Principal Investigators

  • Eugene Kennedy, MD · NewLink Genetics Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-21
Primary Completion
2018-01-25
Completion
2018-04-16
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03372239 on ClinicalTrials.gov