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

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT03852446

Run by

NewLink Genetics Corporation

People needed

56

Starts

2018-03-05

Expected to finish

2018-08-14

Last updated by the study team

2020-05-28

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Frontage Clinical Services, Inc. — Secaucus, New Jersey, United States

Full record on ClinicalTrials.gov

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