Status:
COMPLETED
Single Ascending Dose PK, Oral Bioavailability and Food Effect Study in Healthy Male Volunteers
Lead Sponsor:
NewLink Genetics Corporation
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
EARLY_PHASE1
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 formul...
Eligibility Criteria
Inclusion
- Non-smoker for at least 3 months
- BMI within 18 to 30 kg/m2
- Able to speak, read, and understand English or Spanish
Exclusion
- 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
Key Trial Info
Start Date :
March 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 14 2018
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT03852446
Start Date
March 5 2018
End Date
August 14 2018
Last Update
May 28 2020
Active Locations (1)
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1
Frontage Clinical Services, Inc.
Secaucus, New Jersey, United States, 07407