Healthy, Psoriasis
Conditions
Brief summary
The main purpose of this study is to evaluate the safety and tolerability of GLPG3970 in healthy volunteers after single oral administrations of GLPG3970 (SAD), compared to placebo (part 1 and 1bis) and after multiple (for 14 days) oral administrations of GLPG3970 (MAD), compared to placebo (part 2). The effect of food (FE) (high-fat, high calorie) on the pharmacokinetics of GLPG3970 and the relative bioavailability (rBA) of an oral solution versus a solid formulation will be assessed (part 3 and 3bis). Part 4 of the study is to evaluate the safety and tolerability of GLPG3970 in subjects with moderate to severe psoriasis when administered daily for 6 weeks.
Interventions
DRUGGLPG3970 capsule
GLPG3970 for oral administration
Placebo for oral administration
GLPG3970 for oral administration
Sponsors
Galapagos NV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Part 1 and 1bis (SAD), Part 2 (MAD) and Part 4 (psoriasis subjects) are randomized, double-blind, placebo-controlled; Part 3 (FE-rBA) and Part 3bis (FE) are randomized, open-label.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
for Part 1, 1bis, 2, 3 and 3bis: * Male between 18-55 years of age (extremes included), on the date of signing the informed consent form (ICF). * A body mass index (BMI) between 18-30 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 must not be below the lower limit of normal range. Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be no greater than 1.5x upper limit of normal range (ULN). 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 for the healthy volunteers part of the study. Inclusion criteria for Part 4: * Male or female between 18-65 years of age (extremes included), on the date of signing the ICF. * Diagnosed with plaque psoriasis ≥6 months. * Screening Psoriasis Area and Severity Index (PASI) ≥12 (moderate to severe) and affected body surface area (BSA) ≥10%. * A body mass index (BMI) between 18-35 kg/m2, inclusive. This list only contains the key inclusion criteria for Part 4 of the study.
Exclusion criteria
for Part 1, 1bis, 2, 3 and 3bis: * Known hypersensitivity to the Investigational Medicinal Product (IMP) ingredients or history of a significant allergic reaction to IMP ingredients as determined by the investigator. * Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus or history of hepatitis from any cause with the exception of hepatitis A that was resolved at least 3 months prior to first dosing of the IMP. * History of or a current immunosuppressive condition (e.g. human immunodeficiency virus \[HIV\] infection). This list only contains the key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number 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 20 months | To evaluate the safety and tolerability of GLPG3970 compared to placebo in adult healthy male subjects as single and multiple ascending oral doses, and in subjects with moderate to severe psoriasis when administered daily for 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 1 and 1bis) | Between Day 1 pre-dose and Day 4 | To evaluate the pharmacokinetics (PK) of oral SAD of GLPG3970 in adult healthy male subjects |
| Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 2) | Between Day 1 pre-dose and Day 17 | To evaluate the PK of oral MAD of GLPG3970 in adult healthy male subjects |
| Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 3 and 3bis, FE) | Between Day 1 pre-dose and Day 4 | To evaluate the food effect on the PK of a single oral dose of GLPG3970 in adult, healthy, subjects |
| Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 3, rBA) | Between Day 1 pre-dose and Day 4 | To evaluate the PK of a single oral dose of GLPG3970 administered as an oral solution versus and oral capsule in adult, healthy, subjects |
| Area under curve (AUC) of GLPG3970 (Part 1 and 1bis) | Between Day 1 pre-dose and Day 4 | To evaluate the PK of oral SAD of GLPG3970 in adult healthy male subjects |
| Area under curve (AUC) of GLPG3970 (Part 2) | Between Day 1 pre-dose and Day 17 | To evaluate the PK of oral MAD of GLPG3970 in adult healthy male subjects |
| Area under curve (AUC) of GLPG3970 (Part 3 and 3bis, FE) | Between Day 1 pre-dose and Day 4 | To evaluate the food effect on the PK of a single oral dose of GLPG3970 under fed conditions (high-fat high calorie) versus fasted conditions in adult, healthy, subjects |
| Area under curve (AUC) of GLPG3970 (Part 3, rBA) | Between Day 1 pre-dose and Day 4 | To evaluate the rBA of an oral solution of GLPG3970 versus an oral capsule of GLPG3970 on the PK of a single oral dose of GLPG3970 in adult, healthy, subjects |
| Terminal elimination half-life (t1/2) of GLPG3970 (Part 1 and 1bis) | Between Day 1 pre-dose and Day 4 | To evaluate the PK of oral SAD of GLPG3970, in adult, healthy, subjects |
| Terminal elimination half-life (t1/2) of GLPG3970 (Part 2) | Between Day 1 pre-dose and Day 17 | To evaluate the PK of oral MAD of GLPG3970, in adult, healthy, subjects |
Countries
Belgium, Moldova, Ukraine
Outcome results
None listed