Clinical trial NCT04976270: A Study to Evaluate How Well Single and Multiple Doses of GLPG3667 Are Tolerated in Healthy, Adult Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2021-07-26
Enrollment: 23
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuations
timeFrame: From screening through study completion, an average of 3 months
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax) of GLPG3667 - SD
timeFrame: Between Day 1 pre-dose and Day 4
measure: Maximum observed plasma concentration (Cmax) of GLPG3667 - MD
timeFrame: Between Day 1 pre-dose and Day 16
measure: Area under the plasma concentration-time curve (AUC) of GLPG3667 - SD
timeFrame: Between Day 1 pre-dose and Day 4
measure: Area under the plasma concentration-time curve (AUC) of GLPG3667 - MD
timeFrame: Between Day 1 pre-dose and Day 16
measure: Terminal elimination half-life (t1/2) of GLPG3667 - SD
timeFrame: Between Day 1 pre-dose and Day 4
measure: Terminal elimination half-life (t1/2) of GLPG3667 - MD
timeFrame: Between Day 1 pre-dose and Day 16
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Drug Research Unit Ghent
Study officials:
affiliation: Galapagos NV
name: Natalia Rueda-Rincon, MD, PhD
role: STUDY_DIRECTOR
References: