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

NCT03102567 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-04-05

No results posted yet for this study

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.

Conditions

  • Healthy
  • Elderly

Interventions

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

Sponsors & Collaborators

  • Galapagos NV

    lead INDUSTRY

Principal Investigators

  • Helen Timis, MBChB MICR · Galapagos NV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-18
Primary Completion
2017-02-13
Completion
2017-02-13

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03102567 on ClinicalTrials.gov