A Study to Evaluate How Well Single and Multiple Doses of GLPG3667 Are Tolerated in Healthy, Adult Subjects

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of GLPG3667 in Adult, Healthy Male Subjects

This study is a phase I, randomized, double-blind, placebo-controlled, single-center, to evaluate the safety, tolerability, and pharmacokinetics (PK) of GLPG3667 after an oral single dose (SD) of GLPG3667 (part 1) and after oral multiple doses (MD) for 13 days of GLPG3667 (part 2) in healthy male subjects.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: GLPG3667

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • Drug Research Unit Ghent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Male between 18 and 55 years of age (extremes included), on the date of signing the informed consent form (ICF).
• A body mass index (BMI) between 18.0 and 30.0 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 electrocardiogram (ECG), and fasting clinical laboratory safety tests, available at screening and prior to randomization. Hemoglobin, neutrophil, lymphocyte, and platelet counts must be above the lower limit of normal range. Total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be below the upper limit of normal. 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 product (IP) ingredients or history of a significant allergic reaction to IP 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 has resolved at least 3 months prior to first dosing of the IP.

This list only contains the key exclusion criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GLPG3667 SD; Participants will receive a single dose of GLPG3667	Drug: GLPG3667; GLPG3667 capsules
Placebo Comparator: Placebo SD; Participants will receive a single dose of matching placebo	Drug: Placebo; Matching placebo capsules
Experimental: GLPG3667 MD; Participants will receive repeated doses of GLPG3667 for 13 days.	Drug: GLPG3667; GLPG3667 capsules
Placebo Comparator: Placebo MD; Participants will receive repeated doses of matching placebo for 13 days.	Drug: Placebo; Matching placebo capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 and multiple oral doses of GLPG3667, in adult, healthy, male subjects compared with placebo	From screening through study completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum observed plasma concentration (Cmax) of GLPG3667 - SD	To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects.	Between Day 1 pre-dose and Day 4
Maximum observed plasma concentration (Cmax) of GLPG3667 - MD	To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects.	Between Day 1 pre-dose and Day 16
Area under the plasma concentration-time curve (AUC) of GLPG3667 - SD	To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects.	Between Day 1 pre-dose and Day 4
Area under the plasma concentration-time curve (AUC) of GLPG3667 - MD	To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects.	Between Day 1 pre-dose and Day 16
Terminal elimination half-life (t1/2) of GLPG3667 - SD	To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects.	Between Day 1 pre-dose and Day 4
Terminal elimination half-life (t1/2) of GLPG3667 - MD	To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects.	Between Day 1 pre-dose and Day 16

Collaborators and Investigators

• Sponsor: Galapagos NV
• Investigators: Study Director: Natalia Rueda-Rincon, MD, PhD, Galapagos NV

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2021
• Primary Completion (Actual): January 14, 2022
• Study Completion (Actual): January 14, 2022

Study Registration Dates

• First Submitted: July 19, 2021
• First Submitted That Met QC Criteria: July 19, 2021
• First Posted (Actual): July 26, 2021

Study Record Updates

• Last Update Posted (Actual): February 14, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: GLPG3667-CL-118; 2021-002488-23 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No