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

Healthy Clinical Trial

Official title:

A Phase 1, Randomized Trial to Compare the Oral Bioavailability of Indoximod Salt and Base Formulations and the Effect of Food (Part 1) and to Evaluate the PK and Safety of Single Ascending Doses of Indoximod (Part 2) in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03372239
• Other study ID #: NLG2108
• Status: Completed
• Phase: Phase 1
• Start date: November 21, 2017
• Est. completion date: April 16, 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 an open-label, 3-period, 6-sequence study. Participants will receive single doses of Indoximod base or salt formulation, in the fasted or fed state. Part 2 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 16, 2018
• Est. primary completion date: January 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male subjects 18 to 55 years of age, inclusive.

• Body mass index (BMI) of 18.0 to 30.0 kg/m2, and a minimum weight of 50.0 kg.

• Non-smoker for at least 3 months prior to Screening.

• Male subjects with female sexual partners of childbearing potential must be using and willing to continue using medically acceptable contraception

• Signed and dated written informed consent

Exclusion Criteria:

• History or presence of any clinically significant abnormality, illness, or disease which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or influence the validity of the results of the study.

• Subjects with autoimmune conditions, inflammatory bowel disease, rheumatoid arthritis, and/or subjects who have undergone an organ transplant.

• Self-reported history of substance or alcohol dependence within the past 2 years, and/or has ever participated or plans to participate in a substance or alcohol rehabilitation program to treat their substance or alcohol dependence.

• Any medical/surgical procedure or trauma within 4 weeks of the first study drug administration or planned within 1 month of study completion.

• Positive urine drug screen.

• Positive breath alcohol test.

• Evidence of clinically significant hepatic or renal impairment

• Inability to fast for a minimum of 14 hours.

• Inability to swallow large capsules/tablets.

• Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).

• Donation or loss of more than 500 mL whole blood within 1 month preceding entry into the Treatment phase and throughout the study.

• Difficulty with venous access or unsuitable or unwilling to undergo catheter insertion.

• History of severe allergic reaction (including anaphylaxis) to any substance, or previous status asthmaticus.

• Treatment with an investigational drug within 5 times the elimination half-life, if known (eg, a marketed product), or within 30 days (if the elimination half-life is unknown) prior to first drug administration or is concurrently enrolled in any research judged not to be scientifically or medically compatible with this study.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Indoximod base formulation
Specified dose on specified days
• Indoximod HCL (salt) formulation
Specified dose on specified days

Other:
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
Canada	INC Research/inVentiv Health	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
NewLink Genetics Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Plasma Concentration-Time Curve	Part 1 (Food Effect)	up to 20 Days
Primary	Pharmacokinetics: Serum concentrations (Cmax/Steady State)	Part 1 (Food Effect)	up to 20 Days
Primary	Pharmacokinetics: Serum concentrations (Cmax/Steady State)	Part 2 (Single rising dose)	up to 4 Days
Secondary	Percentage of patients with adverse events	Part 1	up to 34 Days
Secondary	Percentage of patients with adverse events	Single rising dose	up to 16 Days