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A Study to Assess Safety, Tolerability and Pharmacokinetics of GLPG2451 in Healthy Female 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: NCT02788721
Recruitment Status : Completed
First Posted : June 2, 2016
Last Update Posted : July 12, 2017
Sponsor:
Collaborators:
Pharmaceutical Research Associates
SGS S.A.
Information provided by (Responsible Party):
Galapagos NV

Tracking Information
First Submitted Date  ICMJE May 13, 2016
First Posted Date  ICMJE June 2, 2016
Last Update Posted Date July 12, 2017
Actual Study Start Date  ICMJE April 14, 2016
Actual Primary Completion Date April 27, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2017)
Change versus placebo in the proportion of subjects with adverse events [ Time Frame: Between screening and 182 days after the last dose ]
To assess safety and tolerability of single ascending doses with GLPG2451 versus placebo in healthy subjects
Original Primary Outcome Measures  ICMJE
 (submitted: May 27, 2016)
  • Change versus placebo in the proportion of subjects with adverse events [ Time Frame: Between screening and 14 days after the last dose ]
    To evaluate the safety and tolerability of GLPG2451 and of the combination of GLPG2451/GLPG2222 in comparison to matching placebo after a single oral dose and multiple oral doses in healthy subjets in terms of adverse events
  • Change versus placebo in the proportion of subjects with abnormal laboratory parameters [ Time Frame: Between screening and 14 days after the last dose ]
    To evaluate the safety and tolerability of GLPG2451 and of the combination of GLPG2451/GLPG2222 in comparison to matching placebo after a single oral dose and multiple oral doses in healthy subjets in terms of laboratory parameters
  • Change versus placebo in the proportion of subjects with abnormal ECG [ Time Frame: Between screening and 14 days after the last dose ]
    To evaluate the safety and tolerability of GLPG2451 and of the combination of GLPG2451/GLPG2222 in comparison to matching placebo after a single oral dose and multiple oral doses in healthy subjets in terms of ECG
  • Change versus placebo in the proportion of subjects with abnormal vital signs [ Time Frame: Between screening and 14 days after the last dose ]
    To evaluate the safety and tolerability of GLPG2451 and of the combination of GLPG2451/GLPG2222 in comparison to matching placebo after a single oral dose and multiple oral doses in healthy subjets in terms of vital signs
  • Change versus placebo in the proportion of subjects with abnormal physical examination [ Time Frame: Between screening and 14 days after the last dose ]
    To evaluate the safety and tolerability of GLPG2451 and of the combination of GLPG2451/GLPG2222 in comparison to matching placebo after a single oral dose and multiple oral doses in healthy subjets in terms of Physical examination
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2017)
  • Maximum observed plasma concentration of GLPG2451 (Cmax) given alone [ Time Frame: Between day 1 predose and 175 days after the last dose ]
    To characterize pharmacokinetics of GLPG2451 and its metabolite after a single oral dose in healthy subjects
  • Time of occurrence of Cmax for GLPG2451 and (tmax) given alone [ Time Frame: Between day 1 predose and 175 days after the last dose ]
    To characterize pharmacokinetics of GLPG2451 and its metabolite after a single oral dose in healthy subjects
  • Area under the plasma concentration-time curve (AUC0-t) of GLPG2451 given alone [ Time Frame: Between day 1 predose and 175 days after the last dose ]
    To characterize pharmacokinetics of GLPG2451 and its metabolite after a single oral dose in healthy subjects
Original Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2016)
  • Maximum observed plasma concentration of GLPG2451 (Cmax) given alone or in combination with GLPG2222 [ Time Frame: Between day 1 predose and 14 days after the last dose ]
    To characterize pharmacokinetics of GLPG2451 - after a single oral dose and multiple oral doses in healthy subjects
  • Time of occurrence of Cmax for GLPG2451 (tmax) given alone or in combination with GLPG2222 [ Time Frame: Between day 1 predose and 14 days after the last dose ]
    To characterize pharmacokinetics of GLPG2451 - after a single oral dose and multiple oral doses in healthy subjects
  • Area under the plasma concentration-time curve of GLPG2451 given alone or in combination with GLPG2222 (AUC0-t) [ Time Frame: Between day 1 predose and 14 days after the last dose ]
    To characterize pharmacokinetics of GLPG2451 - after a single oral dose and multiple oral doses in healthy subjects
  • Maximum observed plasma concentration of GLPG2222 given in combination with GLPG2451 (Cmax) [ Time Frame: Between day 1 predose and 14 days after the last dose ]
    To characterize the pharmacokinetics of GLPG2451and GLPG2222 in plasma when administered as combination
  • Time of occurrence of Cmax for GLPG2222 given in combination with GLPG2451 (tmax) [ Time Frame: Between day 1 predose and 14 days after the last dose ]
    To characterize the pharmacokinetics of GLPG2451and GLPG2222 in plasma when administered as combination
  • Area under the plasma concentration -time curve of GLPG2222 given in combination with GLPG2451(AUC0-t) [ Time Frame: Between day 1 predose and 14 days after the last dose ]
    To characterize the pharmacokinetics of GLPG2451and GLPG2222 in plasma when administered as combination
  • ratio of 4-beta-OH-cholesterol/cholesterol in plasma [ Time Frame: Day 1 and Day 14 ]
    To assess the potential of CYP3A4 interaction after repeated oral dosing with GLPG2451
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 GLPG2451 in Healthy Female Subjects
Official Title  ICMJE Assessment of Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Oral Doses of GLPG2451 and of the Combination of GLPG2451 and GLPG2222 in Healthy Female Subjects
Brief Summary The study is a First-in-Human, Phase I, randomized, double-blind, placebo-controlled study evaluating single and multiple ascending oral doses of GLPG2451 and combined multiple doses of GLPG2451 and GLPG2222 in healthy female subjects. The purpose of the study is to evaluate safety and tolerability after single ascending oral doses and of multiple doses of GLPG2451 given to healthy female subjects compared to placebo as well as of multiple doses of the combination of GLPG2451/GLPG2222 compared to GLPG2451/placebo.
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: GLPG2451 single dose
    GLPG2451 oral suspension, single ascending doses, daily
  • Drug: Placebo
    Placebo, oral suspension, daily
Study Arms  ICMJE
  • Experimental: GLPG2451 single dose
    Single dose of GLPG2451 oral suspension at up to 4 dose levels in ascending order
    Intervention: Drug: GLPG2451 single dose
  • Placebo Comparator: Placebo single dose
    Single dose of Placebo oral suspension
    Intervention: Drug: Placebo
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: July 10, 2017)
31
Original Estimated Enrollment  ICMJE
 (submitted: May 27, 2016)
56
Actual Study Completion Date  ICMJE April 27, 2017
Actual Primary Completion Date April 27, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female between 18-65 years of age inclusive, on the day of signing informed consent form (ICF).
  • Of non-childbearing potential defined as surgically sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy), or post-menopausal (at least 12 consecutive months without menstruation, without an alternative medical cause [including hormone replacement therapy]). In addition a determination of follicle stimulating hormone (FSH) can be performed with FSH >35 mIU/ml to further confirm postmenopausal status without menstruation for ≥12 months.
  • 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 electrocardiogram (ECG), Holter monitoring and a laboratory profile prior to the initial study drug administration.
  • Discontinuation of all medications (including over-the-counter medications and 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. In addition, subjects must agree not to take any medications (including over-the-counter medication and herbal supplements), or alcohol during the course of the study.-non-smokers and non-users of any nicotine-containing products.
  • 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 the 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 drug screen (amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, methadone, and tricyclic antidepressants) and alcohol breath test.
  • Able and willing to sign the ICF as approved by the IEC, prior to screening evaluations, and willing to adhere to the prohibitions and restrictions.

Exclusion Criteria:

  • Known hypersensitivity 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 (HBsAg) or hepatitis C virus (HCV) or any 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).
  • Symptoms of clinically significant illness in the 3 months before the initial study drug administration.
  • Presence or having sequelae of gastrointestinal, liver or kidney (creatinine clearance ≤ 80 mL/min using the Cockroft 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.
  • History of malignancy within the past 5 years (except for basal cell carcinoma of the skin or carcinoma in situ of the cervix that has been treated with no evidence of recurrence).
  • Clinically relevant abnormalities detected on ECG and/or Holter regarding either rhythm or conduction (e.g. QTcF ≥ 470 msec, or a known long QT syndrome). A first degree heart block will not be considered as a significant abnormality.
  • Family history (if known) of long QT syndrome in a primary relative.
  • Clinically relevant abnormalities detected on vital signs.
  • Significant blood loss (including blood donation [> 500 mL]), or having had a transfusion of any blood product within 12 weeks prior to the initial study drug administration.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02788721
Other Study ID Numbers  ICMJE GLPG2451-CL-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Galapagos NV
Study Sponsor  ICMJE Galapagos NV
Collaborators  ICMJE
  • Pharmaceutical Research Associates
  • SGS S.A.
Investigators  ICMJE
Study Director: Chris Brearley, MD Galapagos NV
PRS Account Galapagos NV
Verification Date July 2017

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