NCT03102567

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy
• Elderly

Interventions

Type	Name	Description
DRUG	GLPG1205 50mg q.d.	oral gelatin capsule containing 50mg GLPG1205 for q.d. administration - compared to placebo
DRUG	Placebo oral capsule	oral gelatin capsule containing placebo to match study arm 1 - 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

Timeline

• Start date: 2016-10-18
• Primary completion: 2017-02-13
• Completion: 2017-02-13
• First posted: 2017-04-05
• Last updated: 2017-04-05

Locations

1 site across 1 country: Belgium