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

Early Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Indoximod base formulation; Drug: Indoximod HCL (F2) tablets; Other: Placebo

• Registration Number: NCT03852446
• Lead Sponsor: NewLink Genetics Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-05
• Primary Completion: 2018-03-05
• Study Completion: 2018-08-14
• Study First Submitted: 2019-02-21
• Study First Submitted QC: 2019-02-22
• Study First Posted: 2019-02-25
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-26
• Last Update Posted: 2020-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 56

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part 2: Bioavailability and Food Effect	Indoximod base formulation	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
Part 2: Bioavailability and Food Effect	Indoximod HCL (F2) tablets	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
Part 1: Single Ascending Dose	Placebo	-
Part 1: Single Ascending Dose	Indoximod HCL (F2) tablets	-

Primary Outcome Measures

Name	Time	Method
Area Under the Plasma Concentration-Time Curve	up to 20 Days	Part 2
Pharmacokinetics: Serum concentrations (Cmax/Steady State)	up to 4 Days	Part 1

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with adverse events	up to 36 Days	Part 2

Trial Locations

Locations (1)

Frontage Clinical Services, Inc.; 🇺🇸 Secaucus, New Jersey, United States