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

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ClinicalTrials.gov Identifier: NCT03410979
Recruitment Status : Completed
First Posted : January 25, 2018
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

Tracking Information
First Submitted Date  ICMJE January 19, 2018
First Posted Date  ICMJE January 25, 2018
Last Update Posted Date January 25, 2018
Actual Study Start Date  ICMJE November 25, 2016
Actual Primary Completion Date August 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2018)
Change versus placebo in the proportion of subjects with adverse events [ Time Frame: Between screening and 14 days (SAD part) and 15 days (MAD part) after the last dose ]
To assess safety and tolerability of single and multiple ascending doses with GLPG2737 versus placebo in healthy subjects.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2018)
  • Maximum observed plasma concentration (Cmax) of GLPG2737 [ Time Frame: Between Day 1 predose and 5 days after the last dose ]
    To characterize pharmacokinetics of GLPG2737 and its metabolites after single and multiple oral doses in healthy subjects
  • Time of occurrence of Cmax for GLPG2737 (tmax) [ Time Frame: Between Day 1 predose and 5 days after the last dose ]
    To characterize pharmacokinetics of GLPG2737 and its metabolites after single and multiple oral doses in healthy subjects
  • Area under the plasma concentration-time curve (AUC0-t) of GLPG2737 [ Time Frame: Between Day 1 predose and 5 days after the last dose ]
    To characterize pharmacokinetics of GLPG2737 and its metabolites after single and multiple oral doses in healthy subjects
  • Ratio of 4-beta-hydroxycholesterol/cholesterol in plasma after multiple oral doses in healthy subjects [ Time Frame: Day 1 predose and Day 14 ]
    To explore the potential of CYP3A4 interaction with GLPG2737
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess Safety, Tolerability and Pharmacokinetics of GLPG2737 in Healthy Subjects
Official Title  ICMJE A 2-part, Randomized, Double-blind, Placebo-controlled, Sequential Group, Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Oral Doses of GLPG2737 in Healthy Male Subjects
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: GLPG2737 single dose
    GLPG2737 oral suspension, single ascending doses
  • Drug: Placebo single dose
    Placebo, oral suspension.
  • Drug: GLPG2737 multiple dose
    GLPG2737 oral suspension, multiple ascending doses, daily for 14 days.
  • Drug: GLPG2737 multiple dose
    Placebo, oral suspension, daily for 14 days
Study Arms  ICMJE
  • Experimental: GLPG2737 single dose
    Single doses of GLPG2737 oral suspension at up to 5 dose levels in ascending order
    Intervention: Drug: GLPG2737 single dose
  • Placebo Comparator: Placebo single dose
    Single doses of Placebo oral suspension
    Intervention: Drug: Placebo single dose
  • Experimental: GLP2737 multiple dose
    Multiple doses of GLPG2737 oral suspension at up to 3 dose levels in ascending order
    Intervention: Drug: GLPG2737 multiple dose
  • Placebo Comparator: GLPG2737 multiple dose
    Multiple doses of Placebo oral suspension
    Intervention: Drug: GLPG2737 multiple dose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 24, 2018)
79
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 15, 2017
Actual Primary Completion Date August 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03410979
Other Study ID Numbers  ICMJE GLPG2737-CL-101
2016-003626-17 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Galapagos NV
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Galapagos NV
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Chris Brearley, BM, MRCP, MFPM Galapagos NV
PRS Account Galapagos NV
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP