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NCT03852446 · ClinicalTrials.gov registry record · Early Phase 1

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

A Early Phase 1 study of Healthy, sponsored by NewLink Genetics Corporation.

Completed
Registry status
Early Phase 1
Development phase
56
Enrollment target
1
Study location

NCT03852446 is a Early Phase 1 study of Healthy that has completed, run by NewLink Genetics Corporation. The registered enrollment target is 56 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03852446, a Early Phase 1 study of Healthy, has completed, sponsored by NewLink Genetics Corporation.

COMPLETED
Registry status
Early Phase 1
Development phase
56 participants
Enrollment target
1
Study location

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 Studied

Healthy

Interventions

  • OTHER Placebo
  • DRUG Indoximod HCL (F2) tablets
  • DRUG Indoximod base formulation

Study Locations (1)

New Jersey

  • Frontage Clinical Services, Inc. - Secaucus

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2018-03-05
Est. Completion 2018-08-14
Phase Early Phase 1

Sponsor

NewLink Genetics Corporation

31 total trials

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What the Registry Record Tells You About NCT03852446

The ClinicalTrials.gov registry entry for NCT03852446 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (91% lower). The listed sponsor is NewLink Genetics Corporation, which has 31 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT03852446 reports 1 study location spanning 1 distinct geographic area - top geographies include New Jersey.

Frequently Asked Questions

What is clinical trial NCT03852446 about?

NCT03852446 is a clinical study titled "Single Ascending Dose PK, Oral Bioavailability and Food Effect Study in Healthy Male Volunteers". 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 healt...

What is the current status of trial NCT03852446?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 56 participants. The study started on 2018-03-05. Estimated completion is 2018-08-14.

What conditions does trial NCT03852446 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT03852446?

The interventions under investigation include: Placebo (OTHER), Indoximod HCL (F2) tablets (DRUG), Indoximod base formulation (DRUG).

Who is sponsoring clinical trial NCT03852446?

This trial is sponsored by NewLink Genetics Corporation, which has 31 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03852446 being conducted?

This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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