Status:
COMPLETED
A Study to Evaluate the Effects of Single and Multiple Oral Doses of GLPG3667
Lead Sponsor:
Galapagos NV
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
This study is a first-in-human, Phase I, randomized, double-blind, placebo-controlled, single-center, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodyna...
Eligibility Criteria
Inclusion
- Male between 18-55 years of age (extremes included), on the date of signing the informed consent form (ICF)
- A body mass index (BMI) between 18-30 kg/m2, inclusive
- Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests, available at screening and prior to randomization. Hemoglobin, neutrophil, lymphocyte, and platelet counts must be above the lower limit of normal range. Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be within normal ranges. Other clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered not clinically significant in the opinion of the investigator
Exclusion
- Known hypersensitivity to Investigational Medicinal Product (IMP) ingredients or history of a significant allergic reaction to IMP ingredients as determined by the investigator
- Known contraindication or hypersensitivity to Interferon-alpha (IFN-α) or any component of Intron-A® (Note: this criterion is only applicable to subjects in the MAD part)
- Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) or history of hepatitis from any cause with the exception of hepatitis A that was resolved at least 3 months prior to first dosing of the IMP.
Key Trial Info
Start Date :
September 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2020
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04097938
Start Date
September 18 2019
End Date
July 6 2020
Last Update
September 19 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
SGS Belgium NV - Clinical Pharmacology Unit Antwerp
Antwerp, Belgium, 2060