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

NCT03852446 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

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 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.

Conditions

  • Healthy

Interventions

DRUG

Indoximod HCL (F2) tablets

The doses will be ascending per cohort from 600 mg to 2400 mg

DRUG

Indoximod base formulation

Single oral administration of 1200 mg

OTHER

Placebo

The matching placebo doses will be ascending per cohort from 1 to 4 tablets

DRUG

Indoximod HCL (F2) tablets

Single oral administration of 1200 mg

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
2018-03-05
Primary Completion
2018-03-05
Completion
2018-08-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03852446 on ClinicalTrials.gov