First-in-Human Exploratory Single Ascending Dose of GLPG0974

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: GLPG0974

Study type: Interventional

Funder types: Industry

Identifiers

NCT01496937

GLPG0974-CL-101

Details and patient eligibility

About

The purpose of this exploratory first-in-human study is to evaluate the amount of GLPG0974 present in the blood (pharmacokinetics) after single oral doses of GLPG0974 given to healthy subjects.

Furthermore, during the course of the study, safety and tolerability as well as the effects of GLPG0974 on mechanism of action-related parameters in the blood (pharmacodynamics) will be characterized compared to placebo.

Enrollment: 32 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male, age 18-50 years
• BMI between 18-30 kg/m2

Exclusion criteria

• Any condition that might interfere with the procedures or tests in this study
• Drug or alcohol abuse
• Smoking

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

32 participants in 2 patient groups, including a placebo group

GLPG0974 oral solution

Experimental group

Description:

GLPG0974 oral solution

Treatment:

Drug: GLPG0974

Drug: GLPG0974

Placebo oral solution

Placebo Comparator group

Description:

Placebo oral solution

Treatment:

Drug: GLPG0974

Drug: GLPG0974