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

Healthy Clinical Trial

— NLG2111  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03852446
• Other study ID #: NLG2111
• Status: Completed
• Phase: Early Phase 1
• Start date: March 5, 2018
• Est. completion date: August 14, 2018

Study information

• Verified date: May 2020
• Source: Lumos Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 14, 2018
• Est. primary completion date: March 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Indoximod HCL (F2) tablets
The doses will be ascending per cohort from 600 mg to 2400 mg
• 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

Locations

Country	Name	City	State
United States	Frontage Clinical Services, Inc.	Secaucus	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
NewLink Genetics Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Plasma Concentration-Time Curve	Part 2	up to 20 Days
Primary	Pharmacokinetics: Serum concentrations (Cmax/Steady State)	Part 2	up to 20 Days
Primary	Pharmacokinetics: Serum concentrations (Cmax/Steady State)	Part 1	up to 4 Days
Secondary	Percentage of patients with adverse events	Part 1	up to 18 Days
Secondary	Percentage of patients with adverse events	Part 2	up to 36 Days