A Study in Healthy Male Volunteers to Look at How the Test Medicine GLPG1690 is Taken up by the Body When Given by Mouth and Into a Vein as an Injection

February 11, 2019 updated by: Galapagos NV

A Phase 1, Open-label, Single-center Study to Investigate the Pharmacokinetics and Metabolism of GLPG1690 in Healthy Male Subjects Following Single Intravenous GLPG1690 Microtracer and Oral [14C]-GLPG1690 Administrations.

The sponsor wants to investigate how well the test medicine is taken up by the body when given orally (by mouth) as a tablet or capsule and as a solution for infusion (into a vein). The capsule and the solution will be radiolabelled. 'Radiolabelled' means that the test medicine has a radioactive component which helps us to track where the test medicine is in the body.

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.
8

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

  • United Kingdom
      • Ruddington, United Kingdom, NG11 6JS
        • Quotient Sciences Limited

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

30 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Able and willing to comply with the clinical study protocol (CSP) requirements and sign the informed consent form (ICF) as approved by the Independent Ethics Committee (IEC), before any screening evaluations.
  • Male subjects between 30 to 64 years of age (extremes included), on the date of signing the ICF.
  • A body mass index between 18 to 32 kg/m2 (extremes included).
  • Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead ECG, and fasting clinical laboratory safety tests, and not having had any clinically significant illness in the 3 months before first investigational medicinal product (IMP) administration.
  • Having a regular and (at least) daily defecation pattern.
  • Able and willing to comply with restrictions on prior and concomitant medication as described in the protocol.
  • Nonsmoker, defined as an individual who has abstained from smoking (or the use of e-cigarettes or nicotine containing products) from at least 2 months before screening. Having a breath carbon monoxide reading of ≤10 parts per million.
  • Negative urine drug screen (e.g. amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, methadone, tricyclic antidepressants) and alcohol breath test.
  • Male subjects with female partners of childbearing potential willing to comply with the contraceptive methods described in the protocol from the time of the first IMP administration, during the clinical study, and for at least 90 days after the last IMP administration.

Exclusion Criteria:

  • Known hypersensitivity to IMP ingredients or history of a significant allergic reaction to IMP ingredients as determined by the investigator, such as anaphylaxis requiring hospitalization, and/or known sensitivity to IMP or the excipients (e.g. lactose). Hayfever is allowed unless active.
  • Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) antibody, or history of hepatitis from any cause with the exception of a history of hepatitis A infection at least 12 weeks before first IMP administration.
  • History of or a current immunosuppressive condition (e.g. human immunodeficiency virus [HIV] infection).
  • Presence or sequelae of gastrointestinal, liver, kidney (creatinine clearance ≤80 mL/min, using the Cockcroft-Gault formula), or other conditions known to interfere with the absorption, distribution, metabolism, and excretion (ADME) properties of drugs. Subjects with documented Gilbert's syndrome are eligible for inclusion in the study.
  • History of malignancy within the past 5 years (except for basal cell carcinoma of the skin that has been treated and with no evidence of recurrence).
  • Hemoglobin level below the lower limit of normal (LLN; 13.0 g/dL). Retesting is allowed once.
  • Significant blood loss (including blood donation [>450 mL]) or transfusion of any blood product within 12 weeks before screening.
  • Active drug abuse (per investigator judgment) or alcohol abuse (more than three glasses of wine, beer, or equivalent/day) within 3 months before first IMP administration.
  • Concurrent participation or participation in a drug, drug/device or biologic investigational research study within 12 weeks or 5 half-lives of the drug, whichever is longer, before first IMP administration.
  • Radiation exposure, including that from the present study, excluding background radiation but including diagnostic Xrays and other medical exposures, exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, can participate in the study.

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: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

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: GLPG1690 oral and IV
GLPG1690 film-coated tablets followed by [14C]-GLPG1690 solution for infusion
Drug: GLPG1690 film-coated tablets
a single oral dose of GLPG1690
Drug: [14C]-GLPG1690 solution for infusion
a 15-minute IV infusion [14C]-GLPG1690
Experimental: [14C]-GLPG1690 capsules
Drug: [14C]-GLPG1690 capsules
single oral dose of [14C]-GLPG1690

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 of total radioactivity excreted in urine and feces combined (µg) from baseline at Day 10 (Part 2)
Time Frame: From Day 1 pre-dose up to Day 10
To assess the mass balance using [14C]-GLPG1690.
From Day 1 pre-dose up to Day 10
Maximum observed plasma concentration (Cmax) of total radioactivity (Part 2).
Time Frame: From Day 1 pre-dose up to Day 10
To assess the pharmacokinetics (PK) of GLPG1690 and its main metabolites in plasma
From Day 1 pre-dose up to Day 10
Maximum observed plasma concentration (Cmax) of GLPG1690 (Part 2).
Time Frame: From Day 1 pre-dose up to Day 10
To assess the pharmacokinetics (PK) of GLPG1690 and its main metabolites in plasma
From Day 1 pre-dose up to Day 10
Area under the plasma concentration-time curve (AUC) of total radioactivity (Part 2).
Time Frame: From Day 1 pre-dose up to Day 10
To assess the PK of GLPG1690 and its main metabolites in plasma
From Day 1 pre-dose up to Day 10
Area under the plasma concentration-time curve (AUC) of GLPG1690 (Part 2).
Time Frame: From Day 1 pre-dose up to Day 10
To assess the PK of GLPG1690 and its main metabolites in plasma
From Day 1 pre-dose up to Day 10
Change in amount of [14C] GLPG1690 excreted in urine and feces combined (µg) from baseline at Day 7 (Part 2).
Time Frame: From Day 1 pre-dose up to Day 7
To better characterize the elimination pathways and metabolite profile of GLPG1690
From Day 1 pre-dose up to Day 7

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
Intravenous (IV) maximum observed plasma concentration (Cmax) of [14C]-GLPG1690 microtracer (MT) (Part 1).
Time Frame: From Day 1 pre-dose up to Day 4
To assess the PK of GLPG1690 and its main metabolites in plasma.
From Day 1 pre-dose up to Day 4
Intravenous (IV) maximum observed plasma concentration (Cmax) of total radioactivity (Part 1).
Time Frame: From Day 1 pre-dose up to Day 4
To assess the PK of GLPG1690 and its main metabolites in plasma.
From Day 1 pre-dose up to Day 4
IV Area under the plasma concentration-time curve (AUC) of [14C]-GLPG1690 microtracer (MT) (Part 1).
Time Frame: From Day 1 pre-dose up to Day 4
To assess the PK of GLPG1690 and its main metabolites in plasma.
From Day 1 pre-dose up to Day 4
IV Area under the plasma concentration-time curve (AUC) of total radioactivity(Part 1).
Time Frame: From Day 1 pre-dose up to Day 4
To assess the PK of GLPG1690 and its main metabolites in plasma.
From Day 1 pre-dose up to Day 4
Safety and tolerability of GLPG1690, assessed by the number of subjects with adverse events (AEs) (Part 1 and Part 2).
Time Frame: From screening through study completion, an average of 2 months
To evaluate the safety and tolerability of GLPG1690 (in Part 1 and Part 2).
From screening through study completion, an average of 2 months

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: Christopher Brearley, BM. MRCP, 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 (Actual)

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.
November 9, 2018

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.
January 17, 2019

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.
January 17, 2019

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).
December 17, 2018

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.
December 24, 2018

First Posted (Actual)

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.
December 26, 2018

Study Record Updates

Last Update Posted (Actual)

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.
February 15, 2019

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.
February 11, 2019

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.
February 1, 2019

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.
  • GLPG1690-CL-107

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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