Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT03102567
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.
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.
Study:
NCT03102567
Study Brief:
Protocol Section:
NCT03102567