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CompletedNCT03410979Updated Jan 25, 2018

A Study to Assess Safety, Tolerability and Pharmacokinetics of GLPG2737 in Healthy Subjects

A Phase 1 interventional study of GLPG2737 single dose and Placebo single dose in Healthy, sponsored by Lakefront Biotherapeutics NV. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-25.

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

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Nov 2016, registered Jan 2018).
Phase
Phase 1
Study type
Interventional
Enrollment
79
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study summary

This study is a first-in-human (FIH), Phase I, single center, randomized, double-blind, placebo-controlled, sequential group study in healthy male subjects to assess the safety, tolerability and PK of single ascending oral doses of GLPG2737 and multiple ascending oral doses of GLPG2737 administered for 14 days.

02

Conditions studied

  • Healthy
03

In context

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.

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

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
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

  1. Male between 18-50 years of age, inclusive, on the date of signing the Informed Consent Form (ICF).
  2. Judged by the investigator to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead ECG, and clinical safety laboratory tests prior to the initial study drug administration.

    Clinical safety laboratory test results must be within the laboratory reference ranges for males or test results that are outside the reference ranges for males need to be considered non clinically significant in the opinion of the investigator. One retest is allowed if deemed appropriate by the investigator.

  3. Liver function tests must meet the following criteria:

    1. aspartate aminotransferase (AST), ALT or alkaline phosphatase (ALP) \<1.2x the upper limit of normal (ULN)
    2. Bilirubin not greater than ULN, however documented Gilbert's syndrome is acceptable. One retest is allowed if deemed appropriate by the investigator.
  4. Subject's screening ECG is considered normal or abnormal but clinically non-significant. QTcF must not exceed 450 msec. First degree heart block will not be considered as a significant abnormality.
  5. Forced expiratory volume in 1 second (FEV1) ≥ 80% of predicted normal for age, gender and height at screening.
  6. Discontinuation of all medications (including over-the-counter and/or prescription medication, dietary supplements, nutraceuticals, vitamins and/or herbal supplements) except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks) at least 2 weeks prior to the first study drug administration.
  7. Negative drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) prior to dosing.
  8. Able and willing to comply with the prohibitions and restrictions as described in the protocol and with the contraceptive requirements as described in the protocol.
  9. Able and willing to sign the ICF as approved by the IEC, prior to any screening evaluations.

Exclusion criteria

Exclusion Criteria:

  1. Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the investigator, such as anaphylaxis requiring hospitalization.
  2. Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) or history of hepatitis from any cause with the exception of hepatitis A.
  3. History of or a current immunosuppressive condition (e.g., human immunodeficiency virus [HIV] infection type 1 and 2).
  4. Clinically significant illness in the 3 months before screening.
  5. Presence or having sequelae of gastrointestinal, liver (except for Gilbert's syndrome), kidney (creatinine clearance ≤ 80 mL/min using the Cockcroft-Gault formula: if calculated result ≤ 80 mL/min, a 24 hour urine collection to determine actual value can be done) or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
  6. History of malignancy within the past 5 years (except for basal cell carcinoma of the skin that has been treated and with no evidence of recurrence).
  7. Treatment with any drug known to have a well-defined potential for toxicity to a major organ in the last 3 months of 5-half-lives of the drug (whichever is longer) before the initial drug administration.
  8. Active drug or alcohol abuse (an average intake of more than 21 glasses of wine or beer or equivalent/week) within 2 years prior to screening.
  9. Participation in a drug, drug/device or biologic investigational research study within 12 weeks or 5 half-lives of the investigational drug, if the half-life is known (whichever is longer) prior to screening.
  10. Any condition or circumstances that in the opinion of the investigator may make a subject unlikely or unable to complete the study or comply with study procedures and requirements.
05

Study design

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

Study arms

  • Experimental
    GLPG2737 single dose

    Single doses of GLPG2737 oral suspension at up to 5 dose levels in ascending order

    Drug: GLPG2737 single dose

  • Placebo comparator
    Placebo single dose

    Single doses of Placebo oral suspension

    Drug: Placebo single dose

  • Experimental
    GLP2737 multiple dose

    Multiple doses of GLPG2737 oral suspension at up to 3 dose levels in ascending order

    Drug: GLPG2737 multiple dose

  • Placebo comparator
    GLPG2737 multiple dose

    Multiple doses of Placebo oral suspension

    Drug: GLPG2737 multiple dose

Interventions

06

What researchers measure

Primary outcomes

  1. Change versus placebo in the proportion of subjects with adverse events

    To assess safety and tolerability of single and multiple ascending doses with GLPG2737 versus placebo in healthy subjects.

    Time frame: Between screening and 14 days (SAD part) and 15 days (MAD part) after the last dose

Secondary outcomes

  1. Maximum observed plasma concentration (Cmax) of GLPG2737

    To characterize pharmacokinetics of GLPG2737 and its metabolites after single and multiple oral doses in healthy subjects

    Time frame: Between Day 1 predose and 5 days after the last dose

  2. Time of occurrence of Cmax for GLPG2737 (tmax)

    To characterize pharmacokinetics of GLPG2737 and its metabolites after single and multiple oral doses in healthy subjects

    Time frame: Between Day 1 predose and 5 days after the last dose

  3. Area under the plasma concentration-time curve (AUC0-t) of GLPG2737

    To characterize pharmacokinetics of GLPG2737 and its metabolites after single and multiple oral doses in healthy subjects

    Time frame: Between Day 1 predose and 5 days after the last dose

  4. Ratio of 4-beta-hydroxycholesterol/cholesterol in plasma after multiple oral doses in healthy subjects

    To explore the potential of CYP3A4 interaction with GLPG2737

    Time frame: Day 1 predose and Day 14

07

Study locations

1 site
  • PRA-EDS
    Groningen, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03410979
Responsible party
Sponsor
First posted
Jan 25, 2018
Start date
Nov 25, 2016
Primary completion
Aug 15, 2017
Completion
Aug 15, 2017
Last update
Jan 25, 2018

Study contacts

Chris Brearley, BM, MRCP, MFPM
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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Studies of the drug tested here: GLPG-2737

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