A Study to Assess Safety, Tolerability and Pharmacokinetics of GLPG3067 in Healthy Subjects.

Summary

The study is a First-in-Human, Phase I, randomized, double-blind, placebo-controlled, single center study, evaluating single and multiple ascending oral doses of GLPG3067 and the combination of GLPG3067 and GLPG2222 and the combination of GLPG3067,GLPG2222 and GLPG2737 given for 14 days in healthy women of non-childbearing potential.

The purpose of the study is to evaluate the safety and tolerability of single ascending oral doses and multiple ascending oral doses of GLPG3067 given to healthy women of non-childbearing potential compared to placebo, as well as of multiple oral doses of the combination of GLPG3067/GLPG2222 compared to matching placebo for each compound and multiple oral doses of the combination of GLPG3067/GLPG2222/GLPG2737 compared to matching placebo for each compound.

Conditions

• Healthy

Interventions

DRUG

GLPG3067 single dose

GLPG3067 oral suspension, single ascending doses, daily

DRUG

Placebo single dose

Placebo, oral suspension, daily

DRUG

GLPG3067 multiple dose

GLPG3067 oral suspension, multiple ascending doses, daily for 14 days

DRUG

Placebo multiple dose

Placebo, oral suspension, daily for 14 days

DRUG

GLPG3067 oral suspension

GLPG3067 oral suspension, single dose, daily

DRUG

GLPG3067 oral tablet

GLPG3067 oral tablet, single dose, daily

DRUG

GLPG3067/GLPG2222 multiple dose

GLPG3067 oral suspension and GLPG2222 oral tablet, multiple doses, daily for 14 days

DRUG

GLPG3067/GLPG2222 Placebo multiple dose

GLPG3067 matching placebo oral suspension and GLPG2222 matching placebo oral tablet, multiple doses, daily for 14 days

DRUG

GLPG3067/GLPG2222/GLPG2737 multiple dose

GLPG3067 oral tablet, GLPG2222 oral tablet and GLPG2737 oral capsule, multiple doses, daily for 14 days

DRUG

GLPG3067/GLPG2222/GLPG2737 Placebo multiple dose

GLPG3067 matching placebo oral tablet, GLPG2222 matching placebo oral tablet and GLPG2737 matching placebo oral capsule, multiple doses, daily for 14 days

Sponsors & Collaborators

• Galapagos NV

  lead INDUSTRY

Principal Investigators

• Magdalena Petkova, MD · Galapagos NV

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-03-28

Primary Completion

2018-02-20

Completion

2018-02-20

Countries

• Belgium

Study Locations