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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01397370

Enrollment

Registered

2011-07-19

Start date

2011-07-31

Completion date

2011-12-31

Last updated

2012-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics

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.

Interventions

DRUGGLPG0492

Oral solution

DRUGPlacebo

Oral solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026