This is a Study to Evaluate the Effect of Aging of Multiple Doses of GLPG1205 in Healthy Subjects

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.

Inclusion criteria

• Male, aged over 18 years
• Able and willing to sign the ICF.
• Able and willing to comply with the requirements of the study.
• Body Mass Index (BMI) between 18 and 30 kg/m² inclusive.
• Weight between 60 and 90 kg, inclusive (Cohort A only).
• Considered by the Investigator to be in good health.
• Discontinuation of all medications with the exception of occasional paracetamol
• 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.
• A non-smoker and not using any nicotine-containing products .
• Negative tests for drug screen, alcohol screen, and cotinine screen.
• Male subjects and their female partners of child-bearing potential must agree to use a highly effective method of contraception.

Exclusion criteria

• Known hypersensitivity to GLPG1205 or excipients of the formulation. A history of significant allergic reaction to any drug, such as anaphylaxis requiring hospitalization.
• Positive serology for hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
• Clinically significant illness in the 12 weeks prior to study screening.
• Current or sequelae of gastrointestinal, liver or kidney disease or any other condition that might interfere with absorption, distribution, metabolism or excretion of drugs.
• History of malignancy in the last 5 years.
• Clinically significant abnormalities on ECG of rhythm or conduction
• Clinically significant abnormalities detected on physical examination or vital signs.
• Clinically significant abnormalities detected on laboratory safety testing
• 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.
• Active drug or alcohol abuse within 2 years prior to study screening.
• 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.
• Concurrent or recent participation in an investigational medicinal research study.