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

Sponsor

Galapagos NV (Industry)

Overall Status

Terminated

CT.gov ID

NCT04575818

Collaborator

(none)

Enrollment

Location

Arms

6.7

Actual Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: GLPG4059 oral suspension Drug: Placebo Drug: GLPG4059 tablet	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Part 1 (SAD) is randomized, double-blind, placebo-controlled; Part 2 (FE and rBA) is randomized, open-label.Part 1 (SAD) is randomized, double-blind, placebo-controlled; Part 2 (FE and rBA) is randomized, open-label.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

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

Actual Study Start Date :

Sep 16, 2020

Actual Primary Completion Date :

Apr 8, 2021

Actual Study Completion Date :

Apr 8, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GLPG4059 SAD Single doses of GLPG4059 at up to 6 dose levels in ascending order	Drug: GLPG4059 oral suspension GLPG4059 for oral administration
Placebo Comparator: Placebo SAD Single doses of placebo	Drug: Placebo Placebo oral suspension
Experimental: GLPG4059 rBA/FE oral suspension fasted Single dose of GLPG4059 in fasted state	Drug: GLPG4059 oral suspension GLPG4059 for oral administration
Experimental: GLPG4059 rBA/FE tablet fed Single dose of GLPG4059 in fed state	Drug: GLPG4059 tablet GLPG4059 for oral administration
Experimental: GLPG4059 rBA/FE tablet fasted Single dose of GLPG4059 in fasted state	Drug: GLPG4059 tablet GLPG4059 for oral administration

Outcome Measures

Primary Outcome Measures

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

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.
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 54 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PRA Health Sciences	Groningen		Netherlands	9728

Sponsors and Collaborators

Galapagos NV

Investigators

Study Director: Magdalena Petkova, MD, Galapagos NV

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Galapagos NV

ClinicalTrials.gov Identifier:

NCT04575818

Other Study ID Numbers:

GLPG4059-CL-101
2020-000036-22

First Posted:

Oct 5, 2020

Last Update Posted:

May 11, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Study Results

No Results Posted as of May 11, 2021