Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Assess Safety, Tolerability and Pharmacokinetics of GLPG2451 in Healthy Male Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03214614
Recruitment Status : Completed
First Posted : July 11, 2017
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

Brief Summary:

The study is a Phase I, randomized, double-blind, placebo-controlled study evaluating multiple ascending oral doses of GLPG2451 and the combination of GLPG2451 and GLPG2222 given for 14 days in healthy male subjects.

The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses of GLPG2451 given to healthy male subjects compared to placebo, as well as of multiple oral doses of the combination of GLPG2451/GLPG2222 compared to placebo.


Condition or disease Intervention/treatment Phase
Healthy Drug: GLPG2451 multiple dose Drug: Placebo multiple dose Drug: GLPG2451/GLPG2222 multiple dose Drug: Combined Placebo multiple dose Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Assessment of Safety, Tolerability and Pharmacokinetics of Multiple Ascending Oral Doses of GLPG2451 and of the Combination of GLPG2451 and GLPG2222 in Healthy Male Subjects
Actual Study Start Date : November 14, 2016
Actual Primary Completion Date : August 25, 2017
Actual Study Completion Date : August 25, 2017

Arm Intervention/treatment
Experimental: GLPG2451 multiple dose
Multiple doses of GLPG2451 oral suspension at up to 3 dose levels in ascending order
Drug: GLPG2451 multiple dose
GLPG2451 oral suspension, multiple ascending doses, daily for 14 days

Placebo Comparator: Placebo multiple dose
Multiple doses of Placebo oral suspension
Drug: Placebo multiple dose
Placebo, oral suspension, daily for 14 days

Experimental: GLPG2451/GLPG2222
Multiple doses of GLPG2451 oral suspension combined GLPG2222 oral suspension at up to 2 dose levels
Drug: GLPG2451/GLPG2222 multiple dose
GLPG2451 oral suspension and GLPG2222 oral suspension, multiple doses, daily for 14 days

Placebo Comparator: Combined Placebo multiple dose
Multiple doses of Combined Placebo oral suspension
Drug: Combined Placebo multiple dose
Combined Placebo, oral suspension, daily for 14 days




Primary Outcome Measures :
  1. Change versus placebo in the proportion of subjects with adverse events [ Time Frame: Between screening and 154 days after the last dose ]
    To assess safety and tolerability of multiple ascending doses and combination of GLPG2451 with GLPG2222 versus placebo in healthy subjects


Secondary Outcome Measures :
  1. Maximum observed plasma concentration of GLPG2451 (Cmax) given alone or in combination with GLPG2222 [ Time Frame: Between screening and 154 days after the last dose ]
    To characterize the pharmacokinetics of GLPG2451 and its metabolite after multiple oral doses in healthy subjects

  2. Time of occurrence of Cmax for GLPG2451 given alone or in combination with GLPG2222 [ Time Frame: Between screening and 154 days after the last dose ]
    To characterize the pharmacokinetics of GLPG2451and its metabolite after multiple oral doses in healthy subjects

  3. Area under the plasma concentration-time curve of GLPG2451 (AUC0-t) given alone or in combination with GLPG2222 [ Time Frame: Between screening and 154 days after the last dose ]
    To characterize the pharmacokinetics of GLPG2451 and its metabolite after multiple oral doses in healthy subjects

  4. 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 GLPG2451



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male between 18 and 50 years of age inclusive, on the date of signing the Informed Consent Form (ICF).
  • A body mass index (BMI) between 18-30 kg/m2, inclusive.
  • 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 or test results that are outside the reference ranges need to be considered non clinically significant in the opinion of the investigator. One retest is allowed during screening period, if deemed appropriate by the investigator.
  • Liver function tests must meet the following criteria: a. Aspartate aminotransferase (AST), ALT, or alkaline phosphatase (ALP) <1.5x ULN.

    b. Bilirubin not greater than ULN, however documented Gilbert's syndrome is acceptable but no more than one subject with confirmed Gilbert's syndrome is allowed per cohort. One retest is allowed during screening period, if deemed appropriate by the investigator.

  • Able and willing to comply with restrictions on prior and concomitant medication as described in the protocol.
  • Non-smokers and non-users of any nicotine-containing products. A non-smoker is defined as an individual who has abstained from smoking for at least 1 year prior to screening. A non-user is defined as an individual who has abstained from any nicotine containing products for at least 1 year prior to the screening.
  • Negative urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, methadone, and tricyclic antidepressants) and negative alcohol breath test.
  • No evidence of lens opacity on slit lamp examination or similar system (e.g. ITrace technology).
  • Agree to the use of a highly effective method of contraception (see protocol).
  • Able and willing to sign the ICF as approved by the IEC, prior to any screening evaluations and willing to adhere to predefined prohibitions and restrictions.

Exclusion Criteria:

  • Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the investigator, such as anaphylaxis requiring hospitalization.
  • Positive serology for hepatitis B virus surface antigen (HBs Ag), hepatitis C virus (HCV), or history of hepatitis from any cause with the exception of hepatitis A.
  • History of or a current immunosuppressive condition (e.g., human immunodeficiency virus [HIV] infection).
  • Clinically significant illness in the 3 months before the initial study drug administration.
  • Presence or sequelae of gastrointestinal, liver, 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 performed) or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
  • 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).
  • 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 the longer) before the initial study drug administration.
  • Active drug or alcohol abuse (more than 3 glasses of wine or beer or equivalent/day) within 2 years prior to the initial study drug administration.
  • Participation in a drug, drug-device combination or biologic investigational research study within 12 weeks or 5 half-lives of the investigational drug (whichever is the longer) prior to initial study drug administration.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03214614


Locations
Layout table for location information
Belgium
SGS LSS Clinical Pharmacology Unit Antwerp
Antwerp, Belgium
Sponsors and Collaborators
Galapagos NV
Investigators
Layout table for investigator information
Study Director: Chris Brearley, MD Galapagos NV
Layout table for additonal information
Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT03214614    
Other Study ID Numbers: GLPG2451-CL-105
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No