- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03787186
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
8
Phase
- 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
-
-
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Ruddington, United Kingdom, NG11 6JS
- Quotient Sciences Limited
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-
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
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 |
Intervention / Treatment |
---|---|
Experimental: GLPG1690 oral and IV
GLPG1690 film-coated tablets followed by [14C]-GLPG1690 solution for infusion
|
a single oral dose of GLPG1690
a 15-minute IV infusion [14C]-GLPG1690
|
Experimental: [14C]-GLPG1690 capsules
|
single oral dose of [14C]-GLPG1690
|
What is the study measuring?
Primary Outcome Measures
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.
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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
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From Day 1 pre-dose up to Day 7
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Secondary Outcome Measures
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
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To evaluate the safety and tolerability of GLPG1690 (in Part 1 and Part 2).
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From screening through study completion, an average of 2 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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)
November 9, 2018
Primary Completion (Actual)
January 17, 2019
Study Completion (Actual)
January 17, 2019
Study Registration Dates
First Submitted
December 17, 2018
First Submitted That Met QC Criteria
December 24, 2018
First Posted (Actual)
December 26, 2018
Study Record Updates
Last Update Posted (Actual)
February 15, 2019
Last Update Submitted That Met QC Criteria
February 11, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Other Study ID 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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