Single Ascending Dose PK, Oral Bioavailability and Food Effect Study in Healthy Male Volunteers
Public ClinicalTrials.gov record NCT03852446. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Study identification
- NCT ID
- NCT03852446
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Early Phase 1
- Lead sponsor
- NewLink Genetics Corporation
- Industry
- Enrollment
- 56 participants
Conditions and interventions
Conditions
Interventions
- Indoximod HCL (F2) tablets Drug
- Indoximod base formulation Drug
- Placebo Other
Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- Male
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 4, 2018
- Primary completion
- Mar 4, 2018
- Completion
- Aug 13, 2018
- Last update posted
- May 27, 2020
2018
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Frontage Clinical Services, Inc. | Secaucus | New Jersey | 07407 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03852446, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 27, 2020 · Synced Jul 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03852446 live on ClinicalTrials.gov.