Multiple Ascending Dose Study of GLPG0492 in Healthy Subjects

Double Blind, Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of GLPG0492 in Healthy Subjects

The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses (MAD) of GLPG0492 given to healthy subjects for 14 days compared to placebo, and to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0492 after multiple oral administrations.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: GLPG0492

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14050
    • PAREXEL Early Phase Clinical Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• healthy male, age 18-50 years
• body mass index (BMI) between 18-29.9 kg/m², inclusive.
• normal values of testosterone (2.49-8.36 ng/mL) and LH (1.7-8.6 U/L)

Exclusion Criteria:

• smoking
• drug or alcohol abuse
• hypersensitivity to any of the ingredients of the study drug

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GLPG0492 oral solution; Multiple ascending doses once daily for 14 days, starting from 5 mg/day	Drug: GLPG0492; Oral solution
Placebo Comparator: Placebo oral solution; Once daily dosing for 14 days	Drug: Placebo; Oral solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the safety and tolerability of GLPG0492 in terms of adverse events, vital signs, ECG and abnormal lab tests in comparison with placebo	Occurrence of adverse events, vital signs, ECG and abnormal lab tests as a measure of safety and tolerability	Up to 2 weeks after last treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the pharmacokinetic profile and metabolism after single and multiple doses of GLPG0492	The plasma levels of GLPG0492 will be determined as a measure of pharmacokinetics, and the plasma and urine levels of GLPG0492 will be used for metabolism investigation	Up to 2h hours after last treatment
To assess whether GLPG0492 induces CYP450, a pharmacodynamic marker by measuring the ratio of β-OH-cortisol /cortisol in urine	To assess the potential of daily doses of GLPG0492 to induce cytochrome P450(CYP3A4), a pharmacodynamic marker, by measurement of the ratio of β-OH-cortisol /cortisol in urine	Up to 24 hours after last treatment

Collaborators and Investigators

• Sponsor: Galapagos NV

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: July 18, 2011
• First Submitted That Met QC Criteria: July 18, 2011
• First Posted (Estimate): July 19, 2011

Study Record Updates

• Last Update Posted (Estimate): February 20, 2012
• Last Update Submitted That Met QC Criteria: February 17, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Safety; Pharmacokinetics; Tolerability; Pharmacodynamics
• Other Study ID Numbers: GLPG0492-CL-102; 2010-024039-18 (EudraCT Number)