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Completed

NCT Number: NCT04106297

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

SGS Belgium NV - Clinical Pharmacology Unit Antwerp, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GLPG3970 oral solution

Drug

GLPG3970 for oral administration

Placebo Oral Solution

Drug

Placebo for oral administration

GLPG3970 capsule

Drug

GLPG3970 for oral administration

Primary outcomes

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

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

    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 outcomes

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    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

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

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

    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

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

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

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

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

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

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

Sponsors and collaborators

Lead sponsor

Lakefront Biotherapeutics NV

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 27, 2019
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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