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Multiple Ascending Dose Study of GLPG0492 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galapagos NV
ClinicalTrials.gov Identifier:
NCT01397370
First received: July 18, 2011
Last updated: February 17, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: GLPG0492
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: 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

Further study details as provided by Galapagos NV:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of GLPG0492 in terms of adverse events, vital signs, ECG and abnormal lab tests in comparison with placebo [ Time Frame: Up to 2 weeks after last treatment ] [ Designated as safety issue: Yes ]
    Occurrence of adverse events, vital signs, ECG and abnormal lab tests as a measure of safety and tolerability


Secondary Outcome Measures:
  • To determine the pharmacokinetic profile and metabolism after single and multiple doses of GLPG0492 [ Time Frame: Up to 2h hours after last treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 24 hours after last treatment ] [ Designated as safety issue: No ]
    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


Enrollment: 24
Study Start Date: July 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01397370

Locations
Germany
Parexel Early Phase Clinical Unit
Berlin, Germany, 14050
Sponsors and Collaborators
Galapagos NV
Investigators
Study Director: Frédéric Vanhoutte, MD Galapagos NV
  More Information

No publications provided

Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT01397370     History of Changes
Other Study ID Numbers: GLPG0492-CL-102, 2010-024039-18
Study First Received: July 18, 2011
Last Updated: February 17, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Galapagos NV:
Safety
Tolerability
Pharmacokinetics
Pharmacodynamics

ClinicalTrials.gov processed this record on November 20, 2014