First-in-Human Exploratory Single Ascending Dose of GLPG0974

Healthy Clinical Trial

Official title:

Exploratory Double-blind Placebo-controlled Study for the Assessment of Pharmacokinetics (PK), Safety, Tolerability, and Pharmacodynamics (PD) of Single Ascending Oral Doses of GLPG0974 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01496937
• Other study ID #: GLPG0974-CL-101
• Status: Completed
• Phase: Phase 1
• First received: December 16, 2011
• Last updated: April 18, 2012
• Start date: December 2011
• Est. completion date: February 2012

Study information

• Verified date: April 2012
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• GLPG0974

• GLPG0974

Locations

Country	Name	City	State
Belgium	SGS Stuivenberg	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The amount of GLPG0974 in plasma over time after a single oral dose	To characterize the amount of GLPG0974 in plasma over time - pharmacokinetics (PK) - after a single oral dose in healthy subjects		No
Secondary	Safety and tolerability	To evaluate the safety and tolerability of GLPG0974 in comparison with placebo after a single oral dose in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments		Yes
Secondary	Inhibition of CD11b on neutrophils in blood after a single oral dose of GLPG0974	To characterize the pharmacodynamics (PD) of GLPG0974 by means of inhibition of expression of CD11b on neutrophils after a single oral dose in healthy subjects		No