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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Galapagos NV
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuations
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- 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.
Arms & Interventions
GLPG3667 MD
Participants will receive repeated doses of GLPG3667 for 13 days.
Intervention: GLPG3667 (Drug)
Placebo SD
Participants will receive a single dose of matching placebo
Intervention: Placebo (Drug)
GLPG3667 SD
Participants will receive a single dose of GLPG3667
Intervention: GLPG3667 (Drug)
Placebo MD
Participants will receive repeated doses of matching placebo for 13 days.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuations
Time Frame: 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 Outcomes
- Maximum observed plasma concentration (Cmax) of GLPG3667 - SD(Between Day 1 pre-dose and Day 4)
- Area under the plasma concentration-time curve (AUC) of GLPG3667 - MD(Between Day 1 pre-dose and Day 16)
- Terminal elimination half-life (t1/2) of GLPG3667 - SD(Between Day 1 pre-dose and Day 4)
- Terminal elimination half-life (t1/2) of GLPG3667 - MD(Between Day 1 pre-dose and Day 16)
- Maximum observed plasma concentration (Cmax) of GLPG3667 - MD(Between Day 1 pre-dose and Day 16)
- Area under the plasma concentration-time curve (AUC) of GLPG3667 - SD(Between Day 1 pre-dose and Day 4)