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

Sponsor

Galapagos NV (Industry)

Overall Status

Completed

CT.gov ID

NCT04976270

Collaborator

(none)

Enrollment

Location

Arms

5.8

Actual Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: GLPG3667 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

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

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jul 20, 2021

Actual Primary Completion Date :

Jan 14, 2022

Actual Study Completion Date :

Jan 14, 2022

Arms and Interventions

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

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 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

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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Drug Research Unit Ghent	Gent		Belgium	9000

Sponsors and Collaborators

Galapagos NV

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Galapagos NV

ClinicalTrials.gov Identifier:

NCT04976270

Other Study ID Numbers:

GLPG3667-CL-118
2021-002488-23

First Posted:

Jul 26, 2021

Last Update Posted:

Feb 14, 2022

Last Verified:

Feb 1, 2022

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:

Study Results

No Results Posted as of Feb 14, 2022