HealthyPhase 1NCT03143712
Study to Assess Bioavailability of GLPG1690 Given as Oral Capsule or Tablet
A Phase 1 study testing GLPG1690 in people with Healthy, run by Lakefront Biotherapeutics NV at 1 site in Belgium.
Trial summary
This study is a Phase I, randomized, open-label, cross-over study with three single-dose treatments to compare the bioavailability of an oral tablet relative to an oral capsule of GLPG1690 after single dose intake in healthy male subjects and to evaluate the effect of food on the bioavailability of the oral tablet. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- GLPG1690
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Apr 2017to 14 Jun 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male between 18-50 years of age, inclusive
- Body mass index (BMI) between 18-30 kg/m2, inclusive, with a weight of at least 50 kg.
- Judged by the investigator to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead ECG, and laboratory findings.
- Discontinuation of all medications except occasional paracetamol at least 2 weeks or 5 half-lives prior to the first study drug administration
- Non-smokers and not using any nicotine-containing products.
- Negative urine drug screen and alcohol breath test.
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- Current sexually active male agrees to use adequate contraception/preventive exposure measures from the time of first dose of study drug, during the study and until 12 weeks after the last study drug dose.
- Subjects should be willing to consume the non-vegetarian high-fat and high-calorie breakfast.
- Able and willing to sign the ICF
Who cannot join
- Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug
- Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) or any history of hepatitis from any cause with the exception of hepatitis A.
- History of or a current immunosuppressive condition.
- Presence of abnormal liver function. Diagnosis of disease of Gilbert is accepted. Retesting is allowed.
- Renal function with an estimated creatinine clearance <80 ml/min based on the Cockcroft-Gault formula. Retesting is allowed.
- Presence of any condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
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- History of malignancy within the past 5 years
- Clinically relevant abnormalities detected on ECG regarding either rhythm or conduction (e.g., QTcF >450 ms, or a known long QT syndrome).
- Clinically relevant abnormalities detected on vital signs.
- Dietary requirements precluding participation in the study
- Significant blood loss (including blood donation [≥450 mL]), or transfusion of any blood product within 8 weeks prior to the signing of ICF.
- Active drug or alcohol abuse within 2 years prior to the initial study drug administration.
- Consumption of large quantities of caffeinated coffee or tea (>6 cups/day), or equivalent.
- Concurrent participation or participation in a drug or drug/device investigational research study.
- Subjects who participated in a previous study with the same compound (GLPG1690).
- Investigator or any sub-investigator, or other staff or relative.
- Any condition or circumstances that in the opinion of the investigator may make a subject unlikely or unable to complete the study or comply with study procedures and requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Study to Compare the Oral Bioavailability of a Tablet of GLPG1690 Relative to a Capsule After Single-dose Intake in Healthy Subjects and to Evaluate the Effect of Food on the Tablet
This study is a Phase I, randomized, open-label, cross-over study with three single-dose treatments to compare the bioavailability of an oral tablet relative to an oral capsule of GLPG1690 after single dose intake in healthy male subjects and to evaluate the effect of food on the bioavailability of the oral tablet.
- Conditions
- Healthy
- Being tested
- GLPG1690
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG1690Drug
Oral administration of GLPG1690 in three different treatment conditions (treatment A through C)
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | GLPG1690 oral capsules after breakfast Receives: Drug: GLPG1690 |
| Treatment B | Experimental | GLPG1690 oral tablets after breakfast Receives: Drug: GLPG1690 |
| Treatment C | Experimental | GLPG1690 oral tablets after overnight fast Receives: Drug: GLPG1690 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the maximum observed plasma concentration of GLPG1690 after single oral doses
Determine the bioavailability of GLPG1690 by assessing PK parameters
Measured: predose at day 1 and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post dosing
Assessment of the time to reach the maximum observed plasma concentration of GLPG1690 after single oral doses
Determine the bioavialability of GLPG1690 by assessing PK parameters
Measured: predose at day 1 and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post dosing
Assessment of the time of the last quantifiable plasma concentration of GLPG1690 after single oral doses
Determine the bioavialability of GLPG1690 by assessing PK parameters
Measured: predose at day 1 and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post dosing
Secondary outcomes (5)
The number of subjects with adverse events
To assess safety and tolerability of GLPG1690
Measured: Throughout the study from screening until the follow up visit (day 7 of dosing period 3)
The number of subjects with abnormal vital signs
To assess safety and tolerability of GLPG1690
Measured: Throughout the study from screening until the follow up visit (day 7 of dosing period 3)
The number of subjects with abnormal ECG
To assess safety and tolerability of GLPG1690
Measured: Throughout the study from screening until the follow up visit (day 7 of dosing period 3)
The number of subjects with abnormal physical examination
To assess safety and tolerability of GLPG1690
Measured: Throughout the study from screening until the follow up visit (day 7 of dosing period 3)
The number of subjects with abnormal laboratory analysis
To assess safety and tolerability of GLPG1690
Measured: Throughout the study from screening until the follow up visit (day 7 of dosing period 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start18 Apr 2017
- Primary completion14 Jun 2017
- Study completion14 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ann Fieuw, MD MSc, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143712
- Sponsor's protocol ID
- GLPG1690-CL-103
- Status last verified
- Jun 2017
- First submitted
- 4 May 2017
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
van der Aar E, Desrivot J, Dupont S, Heckmann B, Fieuw A, Stutvoet S, Fagard L, Van de Wal K, Helmer E. Safety, Pharmacokinetics, and Pharmacodynamics of the Autotaxin Inhibitor GLPG1690 in Healthy Subjects: Phase 1 Randomized Trials. J Clin Pharmacol. 2019 Oct;59(10):1366-1378. doi: 10.1002/jcph.1424. Epub 2019 Apr 23.
PubMed 31012984
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Compare the Oral Bioavailability of a Tablet of GLPG1690 Relative to a Capsule After Single-dose Intake in Healthy Subjects and to Evaluate the Effect of Food on the Tablet
- ClinicalTrials.gov ID
- NCT03143712
- Acronym / sponsor ID
- GLPG1690-CL-103
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- 14 Jun 2017 (actual)
- Study completion
- 14 Jun 2017 (actual)
- First posted
- 8 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a Phase I, randomized, open-label, cross-over study with three single-dose treatments to compare the bioavailability of an oral tablet relative to an oral capsule of GLPG1690 after single dose intake in healthy male subjects and to evaluate the effect of food on the bioavailability of the oral tablet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: GLPG1690GLPG1690 oral capsules after breakfast |
| Treatment B | Experimental | Drug: GLPG1690GLPG1690 oral tablets after breakfast |
| Treatment C | Experimental | Drug: GLPG1690GLPG1690 oral tablets after overnight fast |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male between 18-50 years of age, inclusive
- Body mass index (BMI) between 18-30 kg/m2, inclusive, with a weight of at least 50 kg.
- Judged by the investigator to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead ECG, and laboratory findings.
- Discontinuation of all medications except occasional paracetamol at least 2 weeks or 5 half-lives prior to the first study drug administration
- Non-smokers and not using any nicotine-containing products.
Key exclusion criteria (17 listed)
- Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug
- Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) or any history of hepatitis from any cause with the exception of hepatitis A.
- History of or a current immunosuppressive condition.
- Presence of abnormal liver function. Diagnosis of disease of Gilbert is accepted. Retesting is allowed.
- Renal function with an estimated creatinine clearance <80 ml/min based on the Cockcroft-Gault formula. Retesting is allowed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLPG1690Oral administration of GLPG1690 in three different treatment conditions (treatment A through C) | Drug | Treatment A, Treatment B, Treatment C |
Primary outcome
Assessment of the maximum observed plasma concentration of GLPG1690 after single oral doses
Time frame: predose at day 1 and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post dosing
Determine the bioavailability of GLPG1690 by assessing PK parameters
Assessment of the time to reach the maximum observed plasma concentration of GLPG1690 after single oral doses
Time frame: predose at day 1 and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post dosing
Determine the bioavialability of GLPG1690 by assessing PK parameters
Assessment of the time of the last quantifiable plasma concentration of GLPG1690 after single oral doses
Time frame: predose at day 1 and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post dosing
Determine the bioavialability of GLPG1690 by assessing PK parameters
5 secondary outcomes
The number of subjects with adverse events
Time frame: Throughout the study from screening until the follow up visit (day 7 of dosing period 3)
The number of subjects with abnormal vital signs
Time frame: Throughout the study from screening until the follow up visit (day 7 of dosing period 3)
The number of subjects with abnormal ECG
Time frame: Throughout the study from screening until the follow up visit (day 7 of dosing period 3)
The number of subjects with abnormal physical examination
Time frame: Throughout the study from screening until the follow up visit (day 7 of dosing period 3)
The number of subjects with abnormal laboratory analysis
Time frame: Throughout the study from screening until the follow up visit (day 7 of dosing period 3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Derived from this study: PubMed 31012984van der Aar E, Desrivot J, Dupont S, Heckmann B, Fieuw A, Stutvoet S, Fagard L, Van de Wal K, Helmer E. Safety, Pharmacokinetics, and Pharmacodynamics of the Autotaxin Inhibitor GLPG1690 in Healthy Subjects: Phase 1 Randomized Trials. J Clin Pharmacol. 2019 Oct;59(10):1366-1378. doi: 10.1002/jcph.1424. Epub 2019 Apr 23.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Fieuw, MD MSc study director
Lakefront Biotherapeutics NV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GLPG1690 in people with Healthy, run by Lakefront Biotherapeutics NV at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the maximum observed plasma concentration of GLPG1690 after single oral doses (time frame: predose at day 1 and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post dosing). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03143712, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2017.