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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04106297
• Other study ID #: GLPG3970-CL-101
• Secondary ID: 2019-001803-19
• Status: Completed
• Phase: Phase 1
• Start date: September 10, 2019
• Est. completion date: March 5, 2021

Study information

• Verified date: June 2021
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 5, 2021
• Est. primary completion date: March 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Psoriasis

Intervention

Drug:
• GLPG3970 oral solution
GLPG3970 for oral administration
• Placebo oral solution
Placebo for oral administration
• GLPG3970 capsule
GLPG3970 for oral administration

Locations

Country	Name	City	State
Belgium	SGS Belgium NV - Clinical Pharmacology Unit Antwerp	Antwerp
Moldova, Republic of	Clinical Republican Hospital Arensia Experimental Medicine	Chisinau
Ukraine	ARENSIA Exploratory Medicine Unit	Kyiv

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Countries where clinical trial is conducted

Belgium,  Moldova, Republic of,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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