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A Study to Assess Safety, Tolerability and Pharmacokinetics of GLPG2451 in Healthy Female Subjects

NCT02788721 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2017-07-12

No results posted yet for this study

Summary

The study is a First-in-Human, Phase I, randomized, double-blind, placebo-controlled study evaluating single and multiple ascending oral doses of GLPG2451 and combined multiple doses of GLPG2451 and GLPG2222 in healthy female subjects. The purpose of the study is to evaluate safety and tolerability after single ascending oral doses and of multiple doses of GLPG2451 given to healthy female subjects compared to placebo as well as of multiple doses of the combination of GLPG2451/GLPG2222 compared to GLPG2451/placebo.

Conditions

  • Healthy

Interventions

DRUG

GLPG2451 single dose

GLPG2451 oral suspension, single ascending doses, daily

DRUG

Placebo

Placebo, oral suspension, daily

Sponsors & Collaborators

  • Pharmaceutical Research Associates

    collaborator OTHER

  • SGS S.A.

    collaborator INDUSTRY

  • Galapagos NV

    lead INDUSTRY

Principal Investigators

  • Chris Brearley, MD · Galapagos NV

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-14
Primary Completion
2017-04-27
Completion
2017-04-27

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

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 NCT02788721 on ClinicalTrials.gov