A Study to Evaluate the Effects of Single and Multiple Oral Doses of GLPG3970

Galapagos

Status and phase: Completed; Phase 1

Conditions: Psoriasis; Healthy

Treatments: Drug: GLPG3970 capsule; Drug: Placebo oral solution; Drug: GLPG3970 oral solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT04106297

GLPG3970-CL-101

2019-001803-19 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 exclusion criteria for the healthy volunteers part of the study.

Exclusion criteria for Part 4:

• Subject has evidence of skin conditions other than psoriasis (e.g., eczema) at the time of screening or baseline visit that would interfere with the evaluation of psoriasis.
• Subject is unable to discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot discontinue phototherapy (UVB or PUVA) from signing of the ICF up to the end of the study.

This list only contains the key inclusion criteria for Part 4 of the study.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 8 patient groups, including a placebo group

GLPG3970 SAD

Experimental group

Description:

Single doses of GLPG3970 at up to 6 dose levels in ascending order

Treatment:

Drug: GLPG3970 oral solution

Placebo SAD

Placebo Comparator group

Description:

Single doses of placebo

Treatment:

Drug: Placebo oral solution

GLPG3970 MAD

Experimental group

Description:

Multiple doses of GLPG3970 at up to 4 dose levels in ascending order, daily for 14 days

Treatment:

Drug: GLPG3970 oral solution

Placebo MAD

Placebo Comparator group

Description:

Multiple doses of placebo

Treatment:

Drug: Placebo oral solution

GLPG3970 FE-rBA

Experimental group

Description:

Single dose of GLPG3970 in fed and fasted state

Treatment:

Drug: GLPG3970 oral solution

Drug: GLPG3970 capsule

GLPG3970 FE

Experimental group

Description:

Single dose of GLPG3970 in fed and fasted state

Treatment:

Drug: GLPG3970 oral solution

GLPG3970 in psoriasis subjects

Experimental group

Treatment:

Drug: GLPG3970 oral solution

Placebo in psoriasis subjects

Experimental group

Treatment:

Drug: Placebo oral solution