GLPG0778: Multiple Ascending Oral Doses, Pharmacokinetic, Safety, and Pharmacodynamic Study

Healthy Clinical Trial

Official title:

Double Blind Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Oral Doses of GLPG0778 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01336244
• Other study ID #: GLPG0778-CL-102
• Secondary ID: 2011-000892-16
• Status: Completed
• Phase: Phase 1
• First received: April 13, 2011
• Last updated: October 17, 2011
• Start date: April 2011
• Est. completion date: September 2011

Study information

• Verified date: October 2011
• 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 the study is to evaluate the safety and tolerability of multiple ascending oral doses (MAD) of GLPG0778 given to healthy subjects for 13 days compared to placebo, and to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after multiple oral administrations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• healthy male, age 18-50 years

• body mass index (BMI) between 18-30 kg/m², inclusive.

Exclusion Criteria:

• significantly abnormal platelet function or coagulopathy

• smoking

• drug or alcohol abuse

• hypersensitivity to any of the test substances

Study Design

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• GLPG0778
capsules containing 50 or 100 mg of GLPG0778
• placebo
multiple dose, aqueous formulation, 13 days days, matching ascending dose schedule

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	Occurrence of adverse events	At every study visit, subjects will be asked whether any adverse events have occurred since start of treatment.	Daily during treatment, up to 10 days postdose	No
Primary	Evaluation of hematological, biochemical and cardiovascular parameters.	On predefined timepoints during the study blood and urine samples will be taken, and cardiovascular tests (ECG, blood pressure, heart rate) recorded to assess whether the test compound causes any deviation.	until 10 days postdose.	No
Secondary	Pharmacokinetics of repeated doses	Bloodsamples are taken on various timepoints to assess how much of the study drug is taken up in the blood (absorption), how long it stays in the blood (excretion), and whether any "breakdown"-products of the drug are present (metabolism).	24 hours postdose	No
Secondary	Pharmacodynamics (PD) of GLPG0778	To explore biomarkers of GLPG0778 activity after repeated oral administrations.	up to 10 days postdose	No