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

A First-in-human, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GLPG3970 Single and Multiple Ascending Doses in Adult Healthy Male Subjects, and in Psoriasis Subjects When Administered Daily for 6 Weeks

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Psoriasis
• Intervention / Treatment: Drug: GLPG3970 oral solution; Drug: Placebo oral solution; Drug: GLPG3970 capsule

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2060
    • SGS Belgium NV - Clinical Pharmacology Unit Antwerp
• Moldova, Republic of
  • Chisinau, Moldova, Republic of, MD2025
    • Clinical Republican Hospital Arensia Experimental Medicine
• Ukraine
  • Kyiv, Ukraine, 01135
    • ARENSIA Exploratory Medicine Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo SAD; Single doses of placebo	Drug: Placebo oral solution; Placebo for oral administration
Placebo Comparator: Placebo MAD; Multiple doses of placebo	Drug: Placebo oral solution; Placebo for oral administration
Experimental: GLPG3970 SAD; Single doses of GLPG3970 at up to 6 dose levels in ascending order	Drug: GLPG3970 oral solution; GLPG3970 for oral administration
Experimental: GLPG3970 MAD; Multiple doses of GLPG3970 at up to 4 dose levels in ascending order, daily for 14 days	Drug: GLPG3970 oral solution; GLPG3970 for oral administration
Experimental: GLPG3970 FE-rBA; Single dose of GLPG3970 in fed and fasted state	Drug: GLPG3970 oral solution; GLPG3970 for oral administration; Drug: GLPG3970 capsule; GLPG3970 for oral administration
Experimental: GLPG3970 FE; Single dose of GLPG3970 in fed and fasted state	Drug: GLPG3970 oral solution; GLPG3970 for oral administration
Experimental: GLPG3970 in psoriasis subjects	Drug: GLPG3970 oral solution; GLPG3970 for oral administration
Experimental: Placebo in psoriasis subjects	Drug: Placebo oral solution; Placebo for oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of treatment emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuations	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	From screening through study completion, an average of 20 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 1 and 1bis)	To evaluate the pharmacokinetics (PK) of oral SAD of GLPG3970 in adult healthy male subjects	Between Day 1 pre-dose and Day 4
Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 2)	To evaluate the PK of oral MAD of GLPG3970 in adult healthy male subjects	Between Day 1 pre-dose and Day 17
Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 3 and 3bis, FE)	To evaluate the food effect on the PK of a single oral dose of GLPG3970 in adult, healthy, subjects	Between Day 1 pre-dose and Day 4
Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 3, rBA)	To evaluate the PK of a single oral dose of GLPG3970 administered as an oral solution versus and oral capsule in adult, healthy, subjects	Between Day 1 pre-dose and Day 4
Area under curve (AUC) of GLPG3970 (Part 1 and 1bis)	To evaluate the PK of oral SAD of GLPG3970 in adult healthy male subjects	Between Day 1 pre-dose and Day 4
Area under curve (AUC) of GLPG3970 (Part 2)	To evaluate the PK of oral MAD of GLPG3970 in adult healthy male subjects	Between Day 1 pre-dose and Day 17
Area under curve (AUC) of GLPG3970 (Part 3 and 3bis, FE)	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	Between Day 1 pre-dose and Day 4
Area under curve (AUC) of GLPG3970 (Part 3, rBA)	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	Between Day 1 pre-dose and Day 4
Terminal elimination half-life (t1/2) of GLPG3970 (Part 1 and 1bis)	To evaluate the PK of oral SAD of GLPG3970, in adult, healthy, subjects	Between Day 1 pre-dose and Day 4
Terminal elimination half-life (t1/2) of GLPG3970 (Part 2)	To evaluate the PK of oral MAD of GLPG3970, in adult, healthy, subjects	Between Day 1 pre-dose and Day 17

Collaborators and Investigators

• Sponsor: Galapagos NV

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2019
• Primary Completion (Actual): March 5, 2021
• Study Completion (Actual): March 5, 2021

Study Registration Dates

• First Submitted: September 25, 2019
• First Submitted That Met QC Criteria: September 25, 2019
• First Posted (Actual): September 27, 2019

Study Record Updates

• Last Update Posted (Actual): June 3, 2021
• Last Update Submitted That Met QC Criteria: June 2, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Pharmaceutical Solutions
• Other Study ID Numbers: GLPG3970-CL-101; 2019-001803-19 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No