First-in-Human Single and Multiple Dose of GLPG2222

July 28, 2016 updated by: Galapagos NV

Randomized, Double-blind, Placebo-controlled, First-in-Human Study of GLPG2222 in Healthy Male Subjects

The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG2222 given to healthy subjects, compared to placebo (Part 1). Also, the safety and tolerability of multiple ascending oral doses of GLPG2222 given to healthy subjects daily for 14 days compared to placebo, will be evaluated (Part 2).

Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG2222 present in the blood and urine (pharmacokinetics) will be characterized.

The potential of cytochrome P450 (CYP)3A4 interaction after repeated dosing with GLPG2222 will be explored as well.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium
        • SGS LSS Clinical Pharmacology Unit Antwerp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Males between 18-50 years of age
  • Subjects must have a body mass index between 18-30 kg/m²
  • Subjects must be judged to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram and laboratory profile
  • Subjects must have a screening spirometry with forced expiratory volume in 1 second ≥80% of predicted values for age, gender and height (Part 1 only)

Exclusion Criteria:

  • A subject with a known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug
  • Concurrent participation or participation within 8 weeks prior to the initial study drug administration in a drug/device or biologic investigational research study
  • A subject with active drug or alcohol abuse within 2 years prior to the initial study drug administration
  • Current sexually active (and/or child wish) male; a contraception method must be used

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: GLPG2222 single dose
Single dose of GLPG2222 oral suspension
Drug: GLPG2222 single dose
single ascending doses, oral suspension
Placebo Comparator: Placebo single dose
Single dose of placebo oral suspension
Drug: Placebo single dose
single doses, oral suspension, matching placebo
Experimental: GLPG2222 multiple doses
Multiple doses of GLPG2222 oral suspension
Drug: GLPG2222 multiple doses
multiple ascending doses, daily for 14 days, oral suspension
Placebo Comparator: Placebo multiple doses
Multiple doses of placebo oral suspension
Drug: Placebo multiple doses
multiple doses, daily for 14 days, oral suspension, matching placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change versus placebo in number of subjects with adverse events
Time Frame: Between screening and 7-10 days after the last dose
To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of adverse events
Between screening and 7-10 days after the last dose
Change versus placebo in number of subjects with abnormal laboratory parameters
Time Frame: Between screening and 7-10 days after the last dose
To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal laboratory parameters
Between screening and 7-10 days after the last dose
Change versus placebo in number of subjects with abnormal vital signs
Time Frame: Between screening and 7-10 days after the last dose
To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal vital signs
Between screening and 7-10 days after the last dose
Change versus placebo in number of subjects with abnormal electrocardiogram
Time Frame: Between screening and 7-10 days after the last dose
To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal electrocardiogram
Between screening and 7-10 days after the last dose
Change versus placebo in number of subjects with abnormal physical examination
Time Frame: Between screening and 7-10 days after the last dose
To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal physical examination
Between screening and 7-10 days after the last dose
Change versus placebo in number of subjects with abnormal pulmonary function
Time Frame: Between screening and 4 days after the last dose (Part 1 only)
To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal pulmonary function as measured by spirometry
Between screening and 4 days after the last dose (Part 1 only)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The amount of GLPG2222 in plasma
Time Frame: Between Day 1 predose and 48 hours after the (last) dose
To characterize the amount of GLPG2222 in plasma over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects
Between Day 1 predose and 48 hours after the (last) dose
The amount of GLPG2222 in urine
Time Frame: Between Day 1 predose and 24 hours after the (last) dose
To characterize the amount of GLPG2222 in urine over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects
Between Day 1 predose and 24 hours after the (last) dose
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 interaction after repeated oral dosing with GLPG2222 by means of the ratio of 6-b-hydroxycortisol/cortisol in urine
Twelve hours before dosing on Day 1 and Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Galapagos NV

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Kirsteen Donaldson, MD, Galapagos NV

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 25, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GLPG2222-CL-101
  • 2015-004466-29 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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