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

Galapagos

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: GLPG4059 tablet; Drug: GLPG4059 oral suspension; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04575818

GLPG4059-CL-101

2020-000036-22 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 32 patients

Sex: Male

Ages: 18 to 54 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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32 participants in 5 patient groups, including a placebo group

GLPG4059 SAD

Experimental group

Description:

Single doses of GLPG4059 at up to 6 dose levels in ascending order

Treatment:

Drug: GLPG4059 oral suspension

Placebo SAD

Placebo Comparator group

Description:

Single doses of placebo

Treatment:

Drug: Placebo

GLPG4059 rBA/FE oral suspension fasted

Experimental group

Description:

Single dose of GLPG4059 in fasted state

Treatment:

Drug: GLPG4059 oral suspension

GLPG4059 rBA/FE tablet fed

Experimental group

Description:

Single dose of GLPG4059 in fed state

Treatment:

Drug: GLPG4059 tablet

GLPG4059 rBA/FE tablet fasted

Experimental group

Description:

Single dose of GLPG4059 in fasted state

Treatment:

Drug: GLPG4059 tablet