A Study in Healthy Male Volunteers Investigating the Safety, Absorption and Elimination of Single Doses of GLPG4059

Healthy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04575818
• Other study ID #: GLPG4059-CL-101
• Secondary ID: 2020-000036-22
• Status: Terminated
• Phase: Phase 1
• Start date: September 16, 2020
• Est. completion date: April 8, 2021

Study information

• Verified date: May 2021
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: April 8, 2021
• Est. primary completion date: April 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 54 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• GLPG4059 oral suspension
GLPG4059 for oral administration
• Placebo
Placebo oral suspension
• GLPG4059 tablet
GLPG4059 for oral administration

Locations

Country	Name	City	State
Netherlands	PRA Health Sciences	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuations	To evaluate the safety and tolerability of single ascending oral doses of GLPG4059, in adult, healthy, male subjects compared with placebo.	From screening through study completion, an average of 7 months
Secondary	Maximum observed plasma concentration (Cmax) of GLPG4059	To evaluate the pharmacokinetics (PK) of single ascending oral doses of GLPG4059, in adult, healthy, male subjects.	Between Day 1 pre-dose and Day 4
Secondary	Area under curve (AUC) of GLPG4059	To evaluate the PK of single ascending oral doses of GLPG4059, in adult, healthy, male subjects	Between Day 1 pre-dose and Day 4
Secondary	Terminal elimination half-life (t1/2) of GLPG4059	To evaluate the PK of single ascending oral doses of GLPG4059, in adult, healthy, male subjects	Between Day 1 pre-dose and Day 4