Clinical trial NCT04575818: A Study in Healthy Male Volunteers Investigating the Safety, Absorption and Elimination of Single Doses of GLPG4059
Official title: A First-in-human, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of GLPG4059 in Adult, Healthy, Male Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2020-10-05
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Part 1 (SAD) is randomized, double-blind, placebo-controlled; Part 2 (FE and rBA) is randomized, open-label.
Primary purpose: BASIC_SCIENCE

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).


Eligibility criteria: 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 exclusion criteria.

Primary outcomes:
measure: Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuations
timeFrame: From screening through study completion, an average of 7 months
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax) of GLPG4059
timeFrame: Between Day 1 pre-dose and Day 4
measure: Area under curve (AUC) of GLPG4059
timeFrame: Between Day 1 pre-dose and Day 4
measure: Terminal elimination half-life (t1/2) of GLPG4059
timeFrame: Between Day 1 pre-dose and Day 4
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRA Health Sciences
Study officials:
affiliation: Galapagos NV
name: Magdalena Petkova, MD
role: STUDY_DIRECTOR
References: