NCT03852446

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
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 56 (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 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Indoximod HCL (F2) tablets	The doses will be ascending per cohort from 600 mg to 2400 mg
DRUG	Indoximod base formulation	Single oral administration of 1200 mg
OTHER	Placebo	The matching placebo doses will be ascending per cohort from 1 to 4 tablets
DRUG	Indoximod HCL (F2) tablets	Single oral administration of 1200 mg

Timeline

• Start date: 2018-03-05
• Primary completion: 2018-03-05
• Completion: 2018-08-14
• First posted: 2019-02-25
• Last updated: 2020-05-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study