Trials / Completed
CompletedNCT03372239
Oral Bioavailability,and Food Effect Study and Single Ascending Dose PK Study in Healthy Male Volunteers
A Phase 1, Randomized Trial to Compare the Oral Bioavailability of Indoximod Salt and Base Formulations and the Effect of Food (Part 1) and to Evaluate the PK and Safety of Single Ascending Doses of Indoximod (Part 2) in Healthy Male Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- NewLink Genetics Corporation · Industry
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2017-11-21
- Primary completion
- 2018-01-25
- Completion
- 2018-04-16
- First posted
- 2017-12-13
- Last updated
- 2020-05-28
Locations
1 site across 1 country: Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03372239. Inclusion in this directory is not an endorsement.