Healthy Clinical Trial
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
Verified date | March 2017 |
Source | Galapagos NV |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | February 13, 2017 |
Est. primary completion date | February 13, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Belgium | SGS clinical pharmacology unit | Antwerp |
Lead Sponsor | Collaborator |
---|---|
Galapagos NV |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference between the number of healthy male subjects from different age groups and placebo subjects with adverse events | to assess safety and tolerability in the first placebo controlled part of the study | From screening until the final follow up visit (day 35) | |
Primary | Difference between the number of healthy male subjects from different age groups and placebo subjects with abnormal laboratory evaluations | to assess safety and tolerability in the first placebo controlled part of the study | From screening until the final follow up visit (day 35) | |
Primary | Difference between the number of healthy male subjects from different age groups and placebo subjects with abnormal vital signs | to assess safety and tolerability in the first placebo controlled part of the study | From screening until the final follow up visit (day 35) | |
Primary | Difference between the number of healthy male subjects from different age groups and placebo subjects with abnormal ECG | to assess safety and tolerability in the first placebo controlled part of the study | From screening until the final follow up visit (day 35) | |
Primary | Difference between the number of healthy male subjects from different age groups and placebo subjects with abnormal physical examination | to assess safety and tolerability in the first placebo controlled part of the study | From screening until the final follow up visit (day 35) | |
Primary | Difference between healthy male subjects of different age groups of Cmax of GLPG1205 | To assess PK of GLPG1205 in the first part of the study with different age groups | From day 1 pre-dose until the final follow up visit (day 35) | |
Primary | Difference between healthy male subjects of different age groups of tmax of GLPG1205 | To assess PK of GLPG1205 in the first part of the study with different age groups | From day 1 pre-dose until the final follow up visit (day 35) | |
Primary | Difference between healthy male subjects of different age groups of AUC0-t of GLPG1205 | To assess PK of GLPG1205 in the first part of the study with different age groups | From day 1 pre-dose until the final follow up visit (day 35) | |
Primary | Difference between healthy male subjects of different age groups of apparent terminal half-life (t1/2) of GLPG1205 | To assess PK of GLPG1205 in the first part of the study with different age groups | From day 1 pre-dose until the final follow up visit (day 35) | |
Primary | Assessment of Cmax of GLPG1205 in subjects having received a loading dose of 250mg and subsequent 50mg q.d. maintenance dose | In the open label (part 2) of the study | From day 1 pre-dose until the final follow up visit (day 35) | |
Primary | Assessment of tmax of GLPG1205 in subjects having received a loading dose of 250mg and subsequent 50mg q.d. maintenance dose | In the open label (part 2) of the study | From day 1 pre-dose until the final follow up visit (day 35) | |
Primary | Assessment of AUC0-t of GLPG1205 in subjects having received a loading dose of 250mg and subsequent 50mg q.d. maintenance dose | In the open label (part 2) of the study | From day 1 pre-dose until the final follow up visit (day 35) | |
Primary | Assessment of t1/2 of GLPG1205 in subjects having received a loading dose of 250mg and subsequent 50mg q.d. maintenance dose | In the open label (part 2) of the study | From day 1 pre-dose until the final follow up visit (day 35) | |
Secondary | Assessment of creatinine clearance in healthy elderly subjects | To assess renal function in healthy elderly subjects | From screening until the final follow up visit (day 35) |
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