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

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: GLPG3667; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04976270

2021-002488-23 (EudraCT Number)

GLPG3667-CL-118

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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23 participants in 4 patient groups, including a placebo group

GLPG3667 SD

Experimental group

Description:

Participants will receive a single dose of GLPG3667

Treatment:

Drug: GLPG3667

Placebo SD

Placebo Comparator group

Description:

Participants will receive a single dose of matching placebo

Treatment:

Drug: Placebo

GLPG3667 MD

Experimental group

Description:

Participants will receive repeated doses of GLPG3667 for 13 days.

Treatment:

Drug: GLPG3667

Placebo MD

Placebo Comparator group

Description:

Participants will receive repeated doses of matching placebo for 13 days.

Treatment:

Drug: Placebo