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

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03852446

Acronym

NLG2111

Enrollment

Registered

2019-02-25

Start date

2018-03-05

Completion date

2018-08-14

Last updated

2020-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Indoximod

Brief 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.

Interventions

DRUGIndoximod HCL (F2) tablets

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

DRUGIndoximod base formulation

Single oral administration of 1200 mg

OTHERPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Non-smoker for at least 3 months * BMI within 18 to 30 kg/m2 * Able to speak, read, and understand English or Spanish

Exclusion criteria

* Clinically significant cardiac, pulmonary, hepatic or renal disease * History of substance abuse or alcohol dependence within past 2 years * Inability to fast for a minimum of 14 hours * Inability to swallow large capsules/tablets * Pending legal charges or is on probation

Design outcomes

Primary

Measure	Time frame	Description
Area Under the Plasma Concentration-Time Curve	up to 20 Days	Part 2
Pharmacokinetics: Serum concentrations (Cmax/Steady State)	up to 20 Days	Part 2

Secondary

Measure	Time frame	Description
Percentage of patients with adverse events	up to 18 Days	Part 1

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026