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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: Completed Early Phase 1 study of Healthy, sponsored by NewLink Genetics Corporation.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Part 2
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Indoximod HCL (F2) tablets
- DRUG Indoximod base formulation
Study Locations (1)
New Jersey
- Frontage Clinical Services, Inc. - Secaucus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2018-03-05 |
| Est. Completion | 2018-08-14 |
| Phase | Early Phase 1 |
What the finished NCT03852446 record still lists
NCT03852446 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (91% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03852446's enrollment target sits among peer trials
56 413th of 1090 higher than 665 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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