Single Ascending Dose PK, Oral Bioavailability and Food Effect Study in Healthy Male Volunteers (NLG2111)

NewLink Genetics

Status and phase: Completed; Early Phase 1

Conditions: Healthy

Treatments: Drug: Indoximod base formulation; Other: Placebo; Drug: Indoximod HCL (F2) tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT03852446

NLG2111

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups

Part 1: Single Ascending Dose

Experimental group

Treatment:

Other: Placebo

Drug: Indoximod HCL (F2) tablets

Drug: Indoximod HCL (F2) tablets

Part 2: Bioavailability and Food Effect

Experimental group

Description:

1. Single dose of Indoximod HCL (F2) formulation under fasting conditions 2. Single dose of Indoximod HCL (F2) formulation under fed conditions 3. Single dose of Indoximod base formulation under fasting conditions

Treatment:

Drug: Indoximod HCL (F2) tablets

Drug: Indoximod HCL (F2) tablets

Drug: Indoximod base formulation