Multiple Ascending Dose Study of GLPG0492 in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GLPG0492 oral solution

Multiple ascending doses once daily for 14 days, starting from 5 mg/day

Group Type EXPERIMENTAL

GLPG0492

Intervention Type DRUG

Oral solution

Placebo oral solution

Once daily dosing for 14 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral solution

Interventions

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GLPG0492

Oral solution

Intervention Type DRUG

Placebo

Oral solution

Intervention Type DRUG

Eligibility Criteria

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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)