Multiple Ascending Dose Study of GLPG0974 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: GLPG0974; Drug: Placebo

• Registration Number: NCT01721980
• Lead Sponsor: Galapagos NV

Brief Summary

The purpose of this study is to evaluate the safety and tolerability after multiple ascending oral doses of GLPG0974 given to healthy male subjects for 14 days, compared to placebo.

Furthermore, during the course of the study, the amount of GLPG0974 present in the blood and urine (pharmacokinetics) as well as the effects of GLPG0974 on mechanism of action-related parameters in the blood and stool samples (pharmacodynamics) will be characterized compared to placebo.

Also, the effect of the compound on glucose tolerance will be explored as well as the potential of cytochrome P450 (CYP)3A4 induction by repeated dosing with GLPG0974.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-11-02
• Study First Submitted QC: 2012-11-02
• Study First Posted: 2012-11-06
• Status Verified: 2013-02
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Last Update Submitted: 2013-02-09
• Last Update Posted: 2013-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
50 mg GLPG0974 or placebo	GLPG0974	50 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days
50 mg GLPG0974 or placebo	Placebo	50 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days
100 mg GLPG0974 or placebo	GLPG0974	100 mg GLPG0974 dose as oral capsule or placebo oral capsule, daily for 14 days
100 mg GLPG0974 or placebo	Placebo	100 mg GLPG0974 dose as oral capsule or placebo oral capsule, daily for 14 days
200 mg GLPG0974 or placebo	Placebo	200 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days
400 mg GLPG0974 or placebo	GLPG0974	400 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days
400 mg GLPG0974 or placebo	Placebo	400 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days
200 mg GLPG0974 or placebo	GLPG0974	200 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	Between screening and 7-10 days after the last dose	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

Secondary Outcome Measures

Name	Time	Method
The amount of GLPG0974 in plasma and urine over time after multiple oral dose	Between Day 1 predose and Day 14	To characterize the amount of GLPG0974 in plasma and urine over time - pharmacokinetics (PK) - after multiple oral doses in healthy subjects
Inhibition of CD11b on neutrophils in blood after multiple oral doses of GLPG0974	Day 1 and Day 13, predose until 24h post dose	To characterize the pharmacodynamics (PD) of GLPG0974 by means of inhibition of expression of CD11b on neutrophils after multiple oral doses in healthy subjects

Trial Locations

Locations (1)

SGS LSS Clinical Pharmacology Unit Antwerp; 🇧🇪 Antwerp, Belgium