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

NCT ID: NCT04106297

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-10
• Study Completion Date: 2021-03-05

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.

Conditions

Healthy; Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

GLPG3970 SAD

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

Group Type: EXPERIMENTAL

GLPG3970 oral solution

Intervention Type: DRUG

GLPG3970 for oral administration

Placebo SAD

Single doses of placebo

Group Type: PLACEBO_COMPARATOR

Placebo oral solution

Intervention Type: DRUG

Placebo for oral administration

GLPG3970 MAD

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

Group Type: EXPERIMENTAL

GLPG3970 oral solution

Intervention Type: DRUG

GLPG3970 for oral administration

Placebo MAD

Multiple doses of placebo

Group Type: PLACEBO_COMPARATOR

Placebo oral solution

Intervention Type: DRUG

Placebo for oral administration

GLPG3970 FE-rBA

Single dose of GLPG3970 in fed and fasted state

Group Type: EXPERIMENTAL

GLPG3970 oral solution

Intervention Type: DRUG

GLPG3970 for oral administration

GLPG3970 capsule

Intervention Type: DRUG

GLPG3970 for oral administration

GLPG3970 FE

Single dose of GLPG3970 in fed and fasted state

Group Type: EXPERIMENTAL

GLPG3970 oral solution

Intervention Type: DRUG

GLPG3970 for oral administration

GLPG3970 in psoriasis subjects

Group Type: EXPERIMENTAL

GLPG3970 oral solution

Intervention Type: DRUG

GLPG3970 for oral administration

Placebo in psoriasis subjects

Group Type: EXPERIMENTAL

Placebo oral solution

Intervention Type: DRUG

Placebo for oral administration

Interventions

GLPG3970 oral solution

GLPG3970 for oral administration

Intervention Type: DRUG

Placebo oral solution

Placebo for oral administration

Intervention Type: DRUG

GLPG3970 capsule

GLPG3970 for oral administration

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

• 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.

Exclusion Criteria

• 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).

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Galapagos NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Magdalena Petkova, MD

Role: STUDY_DIRECTOR

Galapagos NV

Locations

SGS Belgium NV - Clinical Pharmacology Unit Antwerp

Antwerp, , Belgium

Clinical Republican Hospital Arensia Experimental Medicine

Chisinau, , Moldova

ARENSIA Exploratory Medicine Unit

Kyiv, , Ukraine

Countries

Belgium; Moldova; Ukraine

Other Identifiers

2019-001803-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GLPG3970-CL-101

Identifier Type: -

Identifier Source: org_study_id