Healthy
Conditions
Brief summary
The main purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of GLPG4059 in healthy volunteers after single oral administrations of GLPG4059 (SAD), compared to placebo (part 1). The effect of food (FE) (high-fat, high calorie) on the pharmacokinetics and relative bioavailability (rBA) of GLPG4059 will be assessed (part 2).
Interventions
DRUGGLPG4059 oral suspension
GLPG4059 for oral administration
DRUGPlacebo
Placebo oral suspension
DRUGGLPG4059 tablet
GLPG4059 for oral administration
Sponsors
Galapagos NV
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Part 1 (SAD) is randomized, double-blind, placebo-controlled; Part 2 (FE and rBA) is randomized, open-label.
Eligibility
Sex/Gender
MALE
Age
18 Years to 54 Years
Healthy volunteers
Yes
Inclusion criteria
* Male between 18-54 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 ECG, and fasting clinical laboratory safety tests, available at screening and prior to randomization. ECG and vital signs parameters must be within the normal ranges. Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be no greater than 1.5x upper limit of normal (ULN). Fasting plasma glucose must be \<6.99 mmol/L, fasting defined as no caloric intake for at least 8 hours and hemoglobin A1c (HbA1c) \<6.5% (48 mmol/mol). The test should be performed in a laboratory using a method that is national glycohemoglobin standardization program (NGSP) certified and standardized to the diabetes control and complications trial (DCCT) assay. 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. This list only contains the key inclusion criteria.
Exclusion criteria
* Known hypersensitivity to Investigational Medicinal Product (IMP) ingredients or history of a significant allergic reaction to IMP ingredients as determined by the investigator. * 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. This list only contains the key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuations | From screening through study completion, an average of 7 months | To evaluate the safety and tolerability of single ascending oral doses of GLPG4059, in adult, healthy, male subjects compared with placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of GLPG4059 | Between Day 1 pre-dose and Day 4 | To evaluate the pharmacokinetics (PK) of single ascending oral doses of GLPG4059, in adult, healthy, male subjects. |
| Area under curve (AUC) of GLPG4059 | Between Day 1 pre-dose and Day 4 | To evaluate the PK of single ascending oral doses of GLPG4059, in adult, healthy, male subjects |
| Terminal elimination half-life (t1/2) of GLPG4059 | Between Day 1 pre-dose and Day 4 | To evaluate the PK of single ascending oral doses of GLPG4059, in adult, healthy, male subjects |
Countries
Netherlands
Outcome results
None listed