Multiple Ascending Dose Study of GLPG0492 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: GLPG0492; Drug: Placebo

• Registration Number: NCT01397370
• 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-18
• Study First Submitted QC: 2011-07-18
• Study First Posted: 2011-07-19
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-17
• Last Update Posted: 2012-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GLPG0492 oral solution	GLPG0492	Multiple ascending doses once daily for 14 days, starting from 5 mg/day
Placebo oral solution	Placebo	Once daily dosing for 14 days

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
To determine the pharmacokinetic profile and metabolism after single and multiple doses of GLPG0492	Up to 2h hours after last treatment	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
To assess whether GLPG0492 induces CYP450, a pharmacodynamic marker by measuring the ratio of β-OH-cortisol /cortisol in urine	Up to 24 hours after last treatment	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

Trial Locations

Locations (1)

Parexel Early Phase Clinical Unit; 🇩🇪 Berlin, Germany