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

Primary Purpose

Healthy, Psoriasis

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

GLPG3970 oral solution

Placebo oral solution

GLPG3970 capsule

About this trial

This is an interventional basic science trial for Healthy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

SGS Belgium NV - Clinical Pharmacology Unit Antwerp
Clinical Republican Hospital Arensia Experimental Medicine
ARENSIA Exploratory Medicine Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

GLPG3970 SAD

Placebo SAD

GLPG3970 MAD

Placebo MAD

GLPG3970 FE-rBA

GLPG3970 FE

GLPG3970 in psoriasis subjects

Placebo in psoriasis subjects

Arm Description

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

Single doses of placebo

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

Multiple doses of placebo

Single dose of GLPG3970 in fed and fasted state

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 2)

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)

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)

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)

To evaluate the PK of oral SAD of GLPG3970 in adult healthy male subjects

Area under curve (AUC) of GLPG3970 (Part 2)

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)

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)

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)

To evaluate the PK of oral SAD of GLPG3970, in adult, healthy, subjects

Terminal elimination half-life (t1/2) of GLPG3970 (Part 2)

To evaluate the PK of oral MAD of GLPG3970, in adult, healthy, subjects

Full Information

NCT ID

NCT04106297

First Posted

September 25, 2019

Last Updated

June 2, 2021

Sponsor

Galapagos NV

1. Study Identification

Unique Protocol Identification Number

NCT04106297

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

September 10, 2019 (Actual)

Primary Completion Date

March 5, 2021 (Actual)

Study Completion Date

March 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Galapagos NV

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy, Psoriasis

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

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.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GLPG3970 SAD

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo SAD

Arm Type

Placebo Comparator

Arm Description

Single doses of placebo

Arm Title

GLPG3970 MAD

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo MAD

Arm Type

Placebo Comparator

Arm Description

Multiple doses of placebo

Arm Title

GLPG3970 FE-rBA

Arm Type

Experimental

Arm Description

Single dose of GLPG3970 in fed and fasted state

Arm Title

GLPG3970 FE

Arm Type

Experimental

Arm Description

Single dose of GLPG3970 in fed and fasted state

Arm Title

GLPG3970 in psoriasis subjects

Arm Type

Experimental

Arm Title

Placebo in psoriasis subjects

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

GLPG3970 oral solution

Intervention Description

GLPG3970 for oral administration

Intervention Type

Drug

Intervention Name(s)

Placebo oral solution

Intervention Description

Placebo for oral administration

Intervention Type

Drug

Intervention Name(s)

GLPG3970 capsule

Intervention Description

GLPG3970 for oral administration

Primary Outcome Measure Information:

Title

Number of treatment emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuations

Description

Time Frame

From screening through study completion, an average of 20 months

Secondary Outcome Measure Information:

Title

Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 1 and 1bis)

Description

To evaluate the pharmacokinetics (PK) of oral SAD of GLPG3970 in adult healthy male subjects

Time Frame

Between Day 1 pre-dose and Day 4

Title

Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 2)

Description

To evaluate the PK of oral MAD of GLPG3970 in adult healthy male subjects

Time Frame

Between Day 1 pre-dose and Day 17

Title

Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 3 and 3bis, FE)

Description

To evaluate the food effect on the PK of a single oral dose of GLPG3970 in adult, healthy, subjects

Time Frame

Between Day 1 pre-dose and Day 4

Title

Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 3, rBA)

Description

To evaluate the PK of a single oral dose of GLPG3970 administered as an oral solution versus and oral capsule in adult, healthy, subjects

Time Frame

Between Day 1 pre-dose and Day 4

Title

Area under curve (AUC) of GLPG3970 (Part 1 and 1bis)

Description

To evaluate the PK of oral SAD of GLPG3970 in adult healthy male subjects

Time Frame

Between Day 1 pre-dose and Day 4

Title

Area under curve (AUC) of GLPG3970 (Part 2)

Description

To evaluate the PK of oral MAD of GLPG3970 in adult healthy male subjects

Time Frame

Between Day 1 pre-dose and Day 17

Title

Area under curve (AUC) of GLPG3970 (Part 3 and 3bis, FE)

Description

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

Time Frame

Between Day 1 pre-dose and Day 4

Title

Area under curve (AUC) of GLPG3970 (Part 3, rBA)

Description

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

Time Frame

Between Day 1 pre-dose and Day 4

Title

Terminal elimination half-life (t1/2) of GLPG3970 (Part 1 and 1bis)

Description

To evaluate the PK of oral SAD of GLPG3970, in adult, healthy, subjects

Time Frame

Between Day 1 pre-dose and Day 4

Title

Terminal elimination half-life (t1/2) of GLPG3970 (Part 2)

Description

To evaluate the PK of oral MAD of GLPG3970, in adult, healthy, subjects

Time Frame

Between Day 1 pre-dose and Day 17

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Magdalena Petkova, MD

Organizational Affiliation

Galapagos NV

Official's Role

Study Director

Facility Information:

Facility Name

SGS Belgium NV - Clinical Pharmacology Unit Antwerp

City

Antwerp

ZIP/Postal Code

2060

Country

Belgium

Facility Name

Clinical Republican Hospital Arensia Experimental Medicine

City

Chisinau

ZIP/Postal Code

MD2025

Country

Moldova, Republic of

Facility Name

ARENSIA Exploratory Medicine Unit

City

Kyiv

ZIP/Postal Code

01135

Country

Ukraine

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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