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
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.
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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