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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: GLPG0778; Drug: placebo

• Registration Number: NCT01336244
• Lead Sponsor: Galapagos NV

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-13
• Study First Submitted QC: 2011-04-14
• Study First Posted: 2011-04-15
• Primary Completion: 2011-08
• Study Completion: 2011-09
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-17
• Last Update Posted: 2011-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 45

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GLPG0778 ascending doses	GLPG0778	Multiple ascending doses for 13 days, ranging from 50 mg twice daily upto a maximum to be determined during escalation.
Placebo	placebo	Twice daily for 13 days, matching the scheme of the multiple ascending dose.

Primary Outcome Measures

Name	Time	Method
Occurrence of adverse events	Daily during treatment, up to 10 days postdose	At every study visit, subjects will be asked whether any adverse events have occurred since start of treatment.
Evaluation of hematological, biochemical and cardiovascular parameters.	until 10 days postdose.	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.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of repeated doses	24 hours postdose	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).
Pharmacodynamics (PD) of GLPG0778	up to 10 days postdose	To explore biomarkers of GLPG0778 activity after repeated oral administrations.

Trial Locations

Locations (1)

SGS Stuivenberg; 🇧🇪 Antwerp, Belgium