Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

First-in-Human Single and Multiple Dose of GLPG1205

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01887106
Recruitment Status : Completed
First Posted : June 26, 2013
Last Update Posted : October 16, 2013
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

Brief Summary:

The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1205 given to healthy male subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1205 given to healthy male subjects daily for 14 days compared to placebo, will be evaluated.

Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG1205 present in the blood and urine (pharmacokinetics) as well as the receptor occupancy by GLPG1205 in blood samples (pharmacodynamics) will be characterized compared to placebo.

Also, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1205 will be explored.


Condition or disease Intervention/treatment Phase
Healthy Drug: GLPG1205 single ascending doses, oral suspension Drug: Placebo single ascending doses, oral suspension Drug: GLPG1205, multiple ascending doses, oral suspension Drug: Placebo, multiple ascending doses, oral suspension Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Placebo-controlled, Dose-ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Oral Doses of GLPG1205 in Healthy Male Subjects
Study Start Date : June 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : October 2013

Arm Intervention/treatment
Experimental: GLPG1205 single dose
Single oral dose of GLPG1205 suspension - ascending doses
Drug: GLPG1205 single ascending doses, oral suspension
Single dose, oral suspension at 10 mg/mL or 50 mg/mL, starting dose of 10mg escalating up to 800mg

Placebo Comparator: Placebo single dose
Single oral dose of placebo suspension
Drug: Placebo single ascending doses, oral suspension
Single dose, oral suspension matching placebo

Experimental: GLPG1205 multiple doses
Multiple oral doses of GLPG1205 suspension - ascending doses
Drug: GLPG1205, multiple ascending doses, oral suspension
Multiple doses, daily for 14 days, oral suspension at 10 mg/mL or 50 mg/mL, anticipated doses: 100mg to 400mg

Placebo Comparator: Placebo multiple doses
Multiple oral doses of placebo suspension
Drug: Placebo, multiple ascending doses, oral suspension
Multiple doses, daily for 14 days, oral suspension matching placebo




Primary Outcome Measures :
  1. Safety and tolerability after single dose [ Time Frame: Between screening and 7-10 days after the last dose ]
    To evaluate the safety and tolerability of GLPG1205 in comparison with placebo after a single oral dose in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments

  2. Safety and tolerability after multiple doses [ Time Frame: Between screening and 7-10 days after the last dose ]
    To evaluate the safety and tolerability of GLPG1205 in comparison with placebo after multiple oral doses daily for 14 days in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments


Secondary Outcome Measures :
  1. The amount of GLPG1205 in plasma and urine over time after a single oral dose [ Time Frame: Between Day 1 predose and 48 hours post dose ]
    To characterize the amount of GLPG1205 in plasma and urine over time - pharmacokinetics (PK) - after a single oral dose in healthy subjects

  2. The amount of GLPG1205 in plasma and urine over time after multiple oral doses [ Time Frame: Between Day 1 predose and Day 16 (48 hours after the last dose) ]
    To characterize the amount of GLPG1205 in plasma and urine over time - pharmacokinetics (PK) - after multiple oral doses in healthy subjects

  3. Ratio of 6-b-hydroxycortisol/cortisol in urine [ Time Frame: Twelve hours before dosing on Day 1 and Day 14 ]
    To assess the potential of CYP3A4 induction after repeated dosing with GLPG1205 by means of the ratio of 6-b-hydroxycortisol/cortisol in urine

  4. Receptor occupancy by GLPG1205 on blood cells after a single dose [ Time Frame: Day 1 predose up to 24 hours post dose ]
    To characterize the pharmacodynamics (PD) of GLPG1205 by means of receptor occupancy by GLPG1205 on blood cells after a single oral dose in healthy subjects

  5. Receptor occupancy by GLPG1205 on blood cells after multiple doses [ Time Frame: Day 1 and Day 14, predose up to 24 hours post dose ]
    To characterize the pharmacodynamics (PD) of GLPG1205 by means of receptor occupancy by GLPG1205 on blood cells after multiple oral doses in healthy subjects



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male, age 18-50 years
  • BMI between 18-30 kg/m2

Exclusion Criteria:

  • Any condition that might interfere with the procedures or tests in this study
  • Drug or alcohol abuse
  • Smoking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01887106


Locations
Layout table for location information
Belgium
SGS LSS Clinical Pharmacology Unit Antwerp
Antwerp, Belgium
Sponsors and Collaborators
Galapagos NV
Investigators
Layout table for investigator information
Study Director: Frédéric Vanhoutte, MD Galapagos NV
Layout table for additonal information
Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT01887106    
Other Study ID Numbers: GLPG1205-CL-101
First Posted: June 26, 2013    Key Record Dates
Last Update Posted: October 16, 2013
Last Verified: October 2013