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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04976270
• Other study ID #: GLPG3667-CL-118
• Secondary ID: 2021-002488-23
• Status: Completed
• Phase: Phase 1
• Start date: July 20, 2021
• Est. completion date: January 14, 2022

Study information

• Verified date: February 2022
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 14, 2022
• Est. primary completion date: January 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• GLPG3667
GLPG3667 capsules
• Placebo
Matching placebo capsules

Locations

Country	Name	City	State
Belgium	Drug Research Unit Ghent	Gent

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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