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

NCT04575818 | Terminated Phase 1

• 2 other identifiers: GLPG4059-CL-1012020-000036-22
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Maximum observed plasma concentration (Cmax) of GLPG4059

  Between Day 1 pre-dose and Day 4

• Area under curve (AUC) of GLPG4059

  Between Day 1 pre-dose and Day 4

• Terminal elimination half-life (t1/2) of GLPG4059

  Between Day 1 pre-dose and Day 4

Study Arms (5)

GLPG4059 SAD

EXPERIMENTAL

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

Drug: GLPG4059 oral suspension

Placebo SAD

PLACEBO COMPARATOR

Single doses of placebo

Drug: Placebo

GLPG4059 rBA/FE oral suspension fasted

EXPERIMENTAL

Single dose of GLPG4059 in fasted state

Drug: GLPG4059 oral suspension

GLPG4059 rBA/FE tablet fed

EXPERIMENTAL

Single dose of GLPG4059 in fed state

Drug: GLPG4059 tablet

GLPG4059 rBA/FE tablet fasted

EXPERIMENTAL

Single dose of GLPG4059 in fasted state

Drug: GLPG4059 tablet

Interventions

GLPG4059 oral suspension DRUG

GLPG4059 for oral administration

GLPG4059 SAD; GLPG4059 rBA/FE oral suspension fasted

Placebo DRUG

Placebo oral suspension

Placebo SAD

GLPG4059 tablet DRUG

GLPG4059 for oral administration

GLPG4059 rBA/FE tablet fasted; GLPG4059 rBA/FE tablet fed

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (1)

PRA Health Sciences

Groningen, 9728, Netherlands

Location

Study Officials

• Magdalena Petkova, MD

  Galapagos NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 5, 2020
• Study Start: September 16, 2020
• Primary Completion: April 8, 2021
• Study Completion: April 8, 2021
• Last Updated: May 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)