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CompletedNCT04106297Updated Sep 19, 2024

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

A Phase 1 interventional study of GLPG3970 oral solution and Placebo oral solution in Healthy and Psoriasis, sponsored by Lakefront Biotherapeutics NV. Completed at 3 sites in 3 countries. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Lakefront Biotherapeutics NV · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
  • Psoriasis

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03

In context

Psoriasis

1,928 studies on the registry are indexed under Psoriasis; 234 are open to participants now.

This study's enrollment of 100 is above the median of 70 across 1,472 interventional studies indexed under Psoriasis.

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Lead sponsor

Lakefront Biotherapeutics NV is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

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.

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    GLPG3970 SAD

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

    Drug: GLPG3970 oral solution

  • Placebo comparator
    Placebo SAD

    Single doses of placebo

    Drug: Placebo oral solution

  • Experimental
    GLPG3970 MAD

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

    Drug: GLPG3970 oral solution

  • Placebo comparator
    Placebo MAD

    Multiple doses of placebo

    Drug: Placebo oral solution

  • Experimental
    GLPG3970 FE-rBA

    Single dose of GLPG3970 in fed and fasted state

    Drug: GLPG3970 oral solution · Drug: GLPG3970 capsule

  • Experimental
    GLPG3970 FE

    Single dose of GLPG3970 in fed and fasted state

    Drug: GLPG3970 oral solution

  • Experimental
    GLPG3970 in psoriasis subjects

    Drug: GLPG3970 oral solution

  • Experimental
    Placebo in psoriasis subjects

    Drug: Placebo oral solution

Interventions

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: From screening through study completion, an average of 20 months

Secondary outcomes

  1. 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

    Time frame: Between Day 1 pre-dose and Day 4

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

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

    Time frame: Between Day 1 pre-dose and Day 17

  3. 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

    Time frame: Between Day 1 pre-dose and Day 4

  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

    Time frame: Between Day 1 pre-dose and Day 4

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

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

    Time frame: Between Day 1 pre-dose and Day 4

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

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

    Time frame: Between Day 1 pre-dose and Day 17

  7. 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

    Time frame: Between Day 1 pre-dose and Day 4

  8. 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

    Time frame: Between Day 1 pre-dose and Day 4

  9. 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

    Time frame: Between Day 1 pre-dose and Day 4

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

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

    Time frame: Between Day 1 pre-dose and Day 17

07

Study locations

3 sites
  • SGS Belgium NV - Clinical Pharmacology Unit Antwerp
    Antwerp, 2060, Belgium
  • Clinical Republican Hospital Arensia Experimental Medicine
    Chisinau, MD2025, Moldova
  • ARENSIA Exploratory Medicine Unit
    Kyiv, 01135, Ukraine
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04106297
Lead sponsor
Lakefront Biotherapeutics NV
Responsible party
Sponsor
First posted
Sep 27, 2019
Start date
Sep 10, 2019
Primary completion
Mar 5, 2021
Completion
Mar 5, 2021
Last update
Sep 19, 2024

Study contacts

Magdalena Petkova, MD
study director · Lakefront Biotherapeutics NV

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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