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

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: GLPG4059 oral suspension; Drug: GLPG4059 tablet; Drug: Placebo

• Registration Number: NCT04575818
• Lead Sponsor: Galapagos NV

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-16
• Study First Submitted: 2020-09-29
• Study First Submitted QC: 2020-09-29
• Study First Posted: 2020-10-05
• Primary Completion: 2021-04-08
• Study Completion: 2021-04-08
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-07
• Last Update Posted: 2021-05-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 32

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
GLPG4059 SAD	GLPG4059 oral suspension	Single doses of GLPG4059 at up to 6 dose levels in ascending order
GLPG4059 rBA/FE tablet fasted	GLPG4059 tablet	Single dose of GLPG4059 in fasted state
Placebo SAD	Placebo	Single doses of placebo
GLPG4059 rBA/FE oral suspension fasted	GLPG4059 oral suspension	Single dose of GLPG4059 in fasted state
GLPG4059 rBA/FE tablet fed	GLPG4059 tablet	Single dose of GLPG4059 in fed state

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.
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

Trial Locations

Locations (1)

PRA Health Sciences; 🇳🇱 Groningen, Netherlands