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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04106297
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Galapagos NV
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Magdalena Petkova, MD
Principal Investigator Affiliation Galapagos NV
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Belgium, Moldova, Republic of, Ukraine
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Healthy, Psoriasis
Arms & Interventions

Arms

Experimental: GLPG3970 SAD

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

Placebo Comparator: Placebo SAD

Single doses of placebo

Experimental: GLPG3970 MAD

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

Placebo Comparator: Placebo MAD

Multiple doses of placebo

Experimental: GLPG3970 FE-rBA

Single dose of GLPG3970 in fed and fasted state

Experimental: GLPG3970 FE

Single dose of GLPG3970 in fed and fasted state

Experimental: GLPG3970 in psoriasis subjects

Experimental: Placebo in psoriasis subjects

Interventions

Drug: - GLPG3970 oral solution

GLPG3970 for oral administration

Drug: - Placebo oral solution

Placebo for oral administration

Drug: - GLPG3970 capsule

GLPG3970 for oral administration

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Antwerp, Belgium

Status

Recruiting

Address

SGS Belgium NV - Clinical Pharmacology Unit Antwerp

Antwerp, , 2060

Chisinau, Moldova, Republic of

Status

Not yet recruiting

Address

Clinical Republican Hospital Arensia Experimental Medicine

Chisinau, , MD2025

ARENSIA Exploratory Medicine Unit, Kyiv, Ukraine

Status

Not yet recruiting

Address

ARENSIA Exploratory Medicine Unit

Kyiv, , 01135

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