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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: GLPG3667; Drug: Placebo

• Registration Number: NCT04976270
• Lead Sponsor: Galapagos NV

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-19
• Study First Submitted QC: 2021-07-19
• Study Start: 2021-07-20
• Study First Posted: 2021-07-26
• Primary Completion: 2022-01-14
• Study Completion: 2022-01-14
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-11
• Last Update Posted: 2022-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
GLPG3667 MD	GLPG3667	Participants will receive repeated doses of GLPG3667 for 13 days.
GLPG3667 SD	GLPG3667	Participants will receive a single dose of GLPG3667
Placebo SD	Placebo	Participants will receive a single dose of matching placebo
Placebo MD	Placebo	Participants will receive repeated doses of matching placebo for 13 days.

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 3 months	To evaluate the safety and tolerability of single and multiple oral doses of GLPG3667, in adult, healthy, male subjects compared with placebo

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Drug Research Unit Ghent; 🇧🇪 Gent, Belgium