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

G

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

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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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