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This is a Study to Evaluate the Effect of Aging of Multiple Doses of GLPG1205 in Healthy 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: NCT03102567
Recruitment Status : Completed
First Posted : April 5, 2017
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

Brief Summary:

This study is a Phase I, single-center, randomized, double-blind, placebo-controlled study to evaluate the effect of aging on safety, tolerability and PK of multiple oral doses of GLPG1205 in healthy male subjects.

The study will comprise of 2 parts, a first part to investigate the effect of aging and a second part to investigate the effect of a loading dose.


Condition or disease Intervention/treatment Phase
Healthy Elderly Drug: GLPG1205 50mg q.d. Drug: Placebo oral capsule Drug: GLPG1205 250 loading dose and 50mg q.d. maintenance dose Phase 1

Detailed Description:

In Part 1, a total of 24 healthy male subjects matched for weight will be divided into 3 age groups:

  • Cohort A: 8 subjects aged 65 to 74 years, inclusive
  • Cohort B: 8 subjects aged ≥ 75 years (1:1 weight matched with subjects of Cohort A [±5 kg])
  • Cohort C: 8 subjects aged between 18-50 years, inclusive (1:1 weight matched with subjects of Cohort A [±5 kg])

Each cohort will be randomized 3:1 to active (6 subjects) and placebo (2 subjects) treatment respectively. Weight matched subjects in Cohorts B and C will be assigned to active treatment and placebo accordingly. Cohorts A and C will be dosed with 50 mg q.d. GLPG1205 for 14 days.

In the open-label Part 2, an additional cohort of 8 subjects aged 65-74 years (Cohort D) will be included to characterize the PK profile after a loading dose followed by multiple doses of GLPG1205 q.d. for 13 days. A 250 mg loading dose will be administered on Day 1 followed by 50 mg q.d. from Day 2 to Day 14.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Effect of Aging of Multiple Oral Doses of GLPG1205 in Healthy Male Subjects
Actual Study Start Date : October 18, 2016
Actual Primary Completion Date : February 13, 2017
Actual Study Completion Date : February 13, 2017

Arm Intervention/treatment
Experimental: GLPG1205 50mg q.d.
oral hard gelatin capsules with 50 mg GLPG1205 for q.d. administration - compared to placebo
Drug: GLPG1205 50mg q.d.
oral gelatin capsule containing 50mg GLPG1205 for q.d. administration - compared to placebo

Placebo Comparator: placebo
oral hard gelatin capsules containing placebo for q.d. administration
Drug: Placebo oral capsule
oral gelatin capsule containing placebo to match study arm 1 - q.d. administration

Experimental: GLPG1205 250 mg loading and 50mg q.d. maintenance
open label - oral hard gelatin capsules with 50 mg GLPG1205 for one time 250 mg loading dose and subsequent 50mg q.d. administration
Drug: GLPG1205 250 loading dose and 50mg q.d. maintenance dose
Open label - oral gelatin capsule containing 50mg GLPG1205 for one time 250mg loading dose and subsequent q.d. administration




Primary Outcome Measures :
  1. Difference between the number of healthy male subjects from different age groups and placebo subjects with adverse events [ Time Frame: From screening until the final follow up visit (day 35) ]
    to assess safety and tolerability in the first placebo controlled part of the study

  2. Difference between the number of healthy male subjects from different age groups and placebo subjects with abnormal laboratory evaluations [ Time Frame: From screening until the final follow up visit (day 35) ]
    to assess safety and tolerability in the first placebo controlled part of the study

  3. Difference between the number of healthy male subjects from different age groups and placebo subjects with abnormal vital signs [ Time Frame: From screening until the final follow up visit (day 35) ]
    to assess safety and tolerability in the first placebo controlled part of the study

  4. Difference between the number of healthy male subjects from different age groups and placebo subjects with abnormal ECG [ Time Frame: From screening until the final follow up visit (day 35) ]
    to assess safety and tolerability in the first placebo controlled part of the study

  5. Difference between the number of healthy male subjects from different age groups and placebo subjects with abnormal physical examination [ Time Frame: From screening until the final follow up visit (day 35) ]
    to assess safety and tolerability in the first placebo controlled part of the study

  6. Difference between healthy male subjects of different age groups of Cmax of GLPG1205 [ Time Frame: From day 1 pre-dose until the final follow up visit (day 35) ]
    To assess PK of GLPG1205 in the first part of the study with different age groups

  7. Difference between healthy male subjects of different age groups of tmax of GLPG1205 [ Time Frame: From day 1 pre-dose until the final follow up visit (day 35) ]
    To assess PK of GLPG1205 in the first part of the study with different age groups

  8. Difference between healthy male subjects of different age groups of AUC0-t of GLPG1205 [ Time Frame: From day 1 pre-dose until the final follow up visit (day 35) ]
    To assess PK of GLPG1205 in the first part of the study with different age groups

  9. Difference between healthy male subjects of different age groups of apparent terminal half-life (t1/2) of GLPG1205 [ Time Frame: From day 1 pre-dose until the final follow up visit (day 35) ]
    To assess PK of GLPG1205 in the first part of the study with different age groups

  10. Assessment of Cmax of GLPG1205 in subjects having received a loading dose of 250mg and subsequent 50mg q.d. maintenance dose [ Time Frame: From day 1 pre-dose until the final follow up visit (day 35) ]
    In the open label (part 2) of the study

  11. Assessment of tmax of GLPG1205 in subjects having received a loading dose of 250mg and subsequent 50mg q.d. maintenance dose [ Time Frame: From day 1 pre-dose until the final follow up visit (day 35) ]
    In the open label (part 2) of the study

  12. Assessment of AUC0-t of GLPG1205 in subjects having received a loading dose of 250mg and subsequent 50mg q.d. maintenance dose [ Time Frame: From day 1 pre-dose until the final follow up visit (day 35) ]
    In the open label (part 2) of the study

  13. Assessment of t1/2 of GLPG1205 in subjects having received a loading dose of 250mg and subsequent 50mg q.d. maintenance dose [ Time Frame: From day 1 pre-dose until the final follow up visit (day 35) ]
    In the open label (part 2) of the study


Secondary Outcome Measures :
  1. Assessment of creatinine clearance in healthy elderly subjects [ Time Frame: From screening until the final follow up visit (day 35) ]
    To assess renal function in healthy elderly subjects



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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male, aged over 18 years
  2. Able and willing to sign the ICF.
  3. Able and willing to comply with the requirements of the study.
  4. Body Mass Index (BMI) between 18 and 30 kg/m² inclusive.
  5. Weight between 60 and 90 kg, inclusive (Cohort A only).
  6. Considered by the Investigator to be in good health.
  7. Discontinuation of all medications with the exception of occasional paracetamol
  8. Have a creatinine clearance (estimated by Cockroft-Gault equation) > 80 mL/min for subjects aged up to 50 years in cohort C and > 60 mL/min for subjects of 65 years and over in cohorts A, B and D.
  9. A non-smoker and not using any nicotine-containing products .
  10. Negative tests for drug screen, alcohol screen, and cotinine screen.
  11. Male subjects and their female partners of child-bearing potential must agree to use a highly effective method of contraception.

Exclusion Criteria:

  1. Known hypersensitivity to GLPG1205 or excipients of the formulation. A history of significant allergic reaction to any drug, such as anaphylaxis requiring hospitalization.
  2. Positive serology for hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
  3. Clinically significant illness in the 12 weeks prior to study screening.
  4. Current or sequelae of gastrointestinal, liver or kidney disease or any other condition that might interfere with absorption, distribution, metabolism or excretion of drugs.
  5. History of malignancy in the last 5 years.
  6. Clinically significant abnormalities on ECG of rhythm or conduction
  7. Clinically significant abnormalities detected on physical examination or vital signs.
  8. Clinically significant abnormalities detected on laboratory safety testing
  9. Significant blood loss, including blood donation of > 450 mL, or receiving a blood transfusion or blood product in the 12 weeks prior to study screening.
  10. Active drug or alcohol abuse within 2 years prior to study screening.
  11. Consumption of large quantities of caffeinated coffee or tea (> 6 cups/day), or equivalent. The consumption of alcohol, methyl-xanthine-containing beverages or foods (e.g., coffee, tea cocoa, cola and chocolate), quinine (e.g., tonic water), grapefruit or grapefruit juice, Seville oranges and poppy seeds within 48 h of study medication administration until the end of the dosing period.
  12. Concurrent or recent participation in an investigational medicinal research study.

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): NCT03102567


Locations
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Belgium
SGS clinical pharmacology unit
Antwerp, Belgium
Sponsors and Collaborators
Galapagos NV
Investigators
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Study Director: Helen Timis, MBChB MICR Galapagos NV
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Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT03102567    
Other Study ID Numbers: GLPG1205-CL-105
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: March 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No