OsteoarthritisPhase 1NCT02851485
Bioavailability Study With GLPG1972
A Phase 1 study testing GLPG1972 600 mg oral solution fasted, GLPG1972 600 mg oral tablet fasted and GLPG1972 600 mg oral tablet fed in people with Osteoarthritis, run by Lakefront Biotherapeutics NV at 1 site in Netherlands.
Trial summary
This is an open-label study to determine the pharmacokinetics of a new tablet formulation of GLPG1972 and to compare it with this of the liquid solution used during the First-in-Human study (GLPG1972-CL-101). 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
- Osteoarthritis
- What is being tested?
- GLPG1972 600 mg oral solution fasted, GLPG1972 600 mg oral tablet fasted and GLPG1972 600 mg oral tablet fed
- 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 siteNetherlands
- Study dates
- Jul 2016to Aug 2016
- 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 and 50 years of age, inclusive, on the day of signing the informed consent form (ICF).
- A 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 (including over-the-counter and/or prescription medication, dietary supplements, nutraceuticals, vitamins and/or herbal supplements) except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks) at least 2 weeks or 5 half-lives of this medication prior to the first study drug administration. In addition, subjects must agree to follow the prohibitions and restrictions for this study.
- Non-smokers and not be using any nicotine-containing products (abstained from smoking for at least 1 year prior to the screening).
- Negative urine and alcohol drug screen (amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, methadone, tricyclic antidepressants, and alcohol).
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- Current sexually active (and/or child wish) male agrees to use adequate contraception (see Section 4.2.4.1) 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 a non-vegetarian high fat and high calorie breakfast.
- Able and willing to sign the ICF as approved by the IEC, prior to screening evaluations
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
- Symptoms of clinically significant illness in the 3 months before the initial study drug administration.
- Presence or having sequelae of gastrointestinal, liver (except for Gilbert's disease) or kidney disease or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- History of malignancy within the past 5 years (except for basal cell carcinoma of the skin that has been treated with no evidence of recurrence).
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- Clinically relevant abnormalities detected on ECG. A first degree heart block or sinus arrhythmia will not be considered as a significant abnormality.
- Clinically relevant abnormalities detected on vital signs.
- Intolerance to cow milk.
- Significant blood loss including blood donation (> 100 mL) or had a transfusion of any blood product within 12 weeks prior to the initial study drug administration.
- Hemoglobin level below 7.5 mmol/L.
- Treatment with any drug known to have a well-defined potential for toxicity to a major organ in the last 3 months preceding the initial study drug administration.
- Active drug or alcohol abuse (an average intake of more than 21 glasses of wine or beer or equivalent/week) within 2 years prior to the initial study drug administration.
- Consumption of a large quantity of coffee, tea (> 6 cups per day) or equivalent.
- Administration of an injectable drug within 30 days prior to the initial study drug administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label Study to Compare the Bioavailability of an Oral Tablet of GLPG1972 Relative to an Oral Solution After Single-dose Intake in Healthy Subjects and to Evaluate the Effect of Food on the Oral Tablet
This is an open-label study to determine the pharmacokinetics of a new tablet formulation of GLPG1972 and to compare it with this of the liquid solution used during the First-in-Human study (GLPG1972-CL-101). The impact of food intake on the oral bioavailability of GLPG1972 administered as tablet will also be investigated in this study. A dose of 600 mg has been selected. The study is a phase I randomized open-label cross-over study with three single dose treatments:
- 600 mg GLPG1972 oral solution after overnight fast,
- 600 mg GLPG1972 oral tablet after overnight fast,
- 600 mg GLPG1972 oral tablet 30 minutes after high-fat high-calorie breakfast.
A washout of at least 6 days between subsequent dosing days is respected so that no measurable plasma levels or biologically significant effects are remaining. There will be frequent assessment of adverse experiences post-dose. Twelve healthy male subjects will be selected according to the inclusion and exclusion criteria and 2 subjects each will be randomized to one of the 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA)
- Conditions
- Osteoarthritis
- Being tested
- GLPG1972 600 mg oral solution fasted, GLPG1972 600 mg oral tablet fasted, GLPG1972 600 mg oral tablet fed
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG1972 600 mg oral solution fastedDrug
dosing after overnight fasting
GLPG1972 600 mg oral tablet fastedDrug
dosing after overnight fasting
GLPG1972 600 mg oral tablet fedDrug
dosing after high-fat high-calorie breakfast
| Study group | Role | What they receive |
|---|---|---|
| GLPG1972 600 mg oral solution fasted | Experimental | 600 mg GLPG1972 administered as oral solution after overnight fasting Receives: Drug: GLPG1972 600 mg oral solution fasted |
| GLPG1972 600 mg oral tablet fasted | Experimental | 600 mg GLPG1972 administered as oral tablet after overnight fasting Receives: Drug: GLPG1972 600 mg oral tablet fasted |
| GLPG1972 600 mg oral tablet fed | Experimental | 600 mg GLPG1972 administered as oral tablet after a high-fat high-calorie breakfast Receives: Drug: GLPG1972 600 mg oral tablet fed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of GLPG1972
To study the pharmacokinetics of 600 mg GLPG1972 administered as oral liquid solution or as oral tablet after overnight fasting or administered as oral tablet after a high-fat high calorie breakfast
Measured: From pre-dose (period 1) until 6 days after the last dose (period 3)
Plasma concentration of GLPG1972 24 hours after dosing
To study the pharmacokinetics of 600 mg GLPG1972 administered as oral liquid solution or as oral tablet after overnight fasting or administered as oral tablet after a high-fat high calorie breakfast
Measured: 24 hours after each dose
The time of the occurrence of Cmax of GLPG1972
To study the pharmacokinetics of 600 mg GLPG1972 administered as oral liquid solution or as oral tablet after overnight fasting or administered as oral tablet after a high-fat high calorie breakfast
Measured: From pre-dose (period 1) until 6 days after the last dose (period 3)
The area under the plasma concentration versus time curve
To study the pharmacokinetics of 600 mg GLPG1972 administered as oral liquid solution or as oral tablet after overnight fasting or administered as oral tablet after a high-fat high calorie breakfast
Measured: From pre-dose until 6 days post-dose for each dosing period
The apparent terminal half-life of GLPG1972
To study the pharmacokinetics of 600 mg GLPG1972 administered as oral liquid solution or as oral tablet after overnight fasting or administered as oral tablet after a high-fat high calorie breakfast
Measured: From pre-dose (period 1) until 6 days after the last dose (period 3)
The number of adverse events reported
To evaluate safety and tolerability of single oral doses of GLPG1972
Measured: From pre-dose until the Follow up (FU) visit anticipated to take place 7-10 days after the last dose
Changes in clinical laboratory evaluations
To evaluate safety and tolerability of single oral doses of GLPG1972
Measured: From pre-dose until the Follow up (FU) visit anticipated to take place 7-10 days after the last dose
Changes in vital signs
To evaluate safety and tolerability of single oral doses of GLPG1972
Measured: From pre-dose until the Follow up (FU) visit anticipated to take place 7-10 days after the last dose
Changes in physical examination parameters
To evaluate safety and tolerability of single oral doses of GLPG1972
Measured: From pre-dose until the Follow up (FU) visit anticipated to take place 7-10 days after the last dose
Changes in ECG parameters
To evaluate safety and tolerability of single oral doses of GLPG1972
Measured: From pre-dose until the Follow up (FU) visit anticipated to take place 7-10 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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)
- Collaborators
- PRA Health Sciences
- Responsible party
- Sponsor
- Investigators
- Ennis Lee, MD, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02851485
- Sponsor's protocol ID
- GLPG1972-CL-103
- Status last verified
- May 2016
- First submitted
- 28 Jul 2016
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Study to Compare the Bioavailability of an Oral Tablet of GLPG1972 Relative to an Oral Solution After Single-dose Intake in Healthy Subjects and to Evaluate the Effect of Food on the Oral Tablet
- ClinicalTrials.gov ID
- NCT02851485
- Acronym / sponsor ID
- GLPG1972-CL-103
- Conditions
- Osteoarthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Study start
- Jul 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 1 Aug 2016 (estimated)
- 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 is an open-label study to determine the pharmacokinetics of a new tablet formulation of GLPG1972 and to compare it with this of the liquid solution used during the First-in-Human study (GLPG1972-CL-101). The impact of food intake on the oral bioavailability of GLPG1972 administered as tablet will also be investigated in this study. A dose of 600 mg has been selected. The study is a phase I randomized open-label cross-over study with three single dose treatments:
- 600 mg GLPG1972 oral solution after overnight fast,
- 600 mg GLPG1972 oral tablet after overnight fast,
- 600 mg GLPG1972 oral tablet 30 minutes after high-fat high-calorie breakfast.
A washout of at least 6 days between subsequent dosing days is respected so that no measurable plasma levels or biologically significant effects are remaining. There will be frequent assessment of adverse experiences post-dose. Twelve healthy male subjects will be selected according to the inclusion and exclusion criteria and 2 subjects each will be randomized to one of the 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GLPG1972 600 mg oral solution fasted | Experimental | Drug: GLPG1972 600 mg oral solution fasted600 mg GLPG1972 administered as oral solution after overnight fasting |
| GLPG1972 600 mg oral tablet fasted | Experimental | Drug: GLPG1972 600 mg oral tablet fasted600 mg GLPG1972 administered as oral tablet after overnight fasting |
| GLPG1972 600 mg oral tablet fed | Experimental | Drug: GLPG1972 600 mg oral tablet fed600 mg GLPG1972 administered as oral tablet after a high-fat high-calorie breakfast |
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 and 50 years of age, inclusive, on the day of signing the informed consent form (ICF).
- A 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 (including over-the-counter and/or prescription medication, dietary supplements, nutraceuticals, vitamins and/or herbal supplements) except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks) at least 2 weeks or 5 half-lives of this medication prior to the first study drug administration. In addition, subjects must agree to follow the prohibitions and restrictions for this study.
- Non-smokers and not be using any nicotine-containing products (abstained from smoking for at least 1 year prior to the screening).
Key exclusion criteria (15 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
- Symptoms of clinically significant illness in the 3 months before the initial study drug administration.
- Presence or having sequelae of gastrointestinal, liver (except for Gilbert's disease) or kidney disease or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
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 |
|---|---|---|
| GLPG1972 600 mg oral solution fasteddosing after overnight fasting | Drug | GLPG1972 600 mg oral solution fasted |
| GLPG1972 600 mg oral tablet fasteddosing after overnight fasting | Drug | GLPG1972 600 mg oral tablet fasted |
| GLPG1972 600 mg oral tablet feddosing after high-fat high-calorie breakfast | Drug | GLPG1972 600 mg oral tablet fed |
Primary outcome
Maximum observed plasma concentration (Cmax) of GLPG1972
Time frame: From pre-dose (period 1) until 6 days after the last dose (period 3)
To study the pharmacokinetics of 600 mg GLPG1972 administered as oral liquid solution or as oral tablet after overnight fasting or administered as oral tablet after a high-fat high calorie breakfast
Plasma concentration of GLPG1972 24 hours after dosing
Time frame: 24 hours after each dose
To study the pharmacokinetics of 600 mg GLPG1972 administered as oral liquid solution or as oral tablet after overnight fasting or administered as oral tablet after a high-fat high calorie breakfast
The time of the occurrence of Cmax of GLPG1972
Time frame: From pre-dose (period 1) until 6 days after the last dose (period 3)
To study the pharmacokinetics of 600 mg GLPG1972 administered as oral liquid solution or as oral tablet after overnight fasting or administered as oral tablet after a high-fat high calorie breakfast
The area under the plasma concentration versus time curve
Time frame: From pre-dose until 6 days post-dose for each dosing period
To study the pharmacokinetics of 600 mg GLPG1972 administered as oral liquid solution or as oral tablet after overnight fasting or administered as oral tablet after a high-fat high calorie breakfast
The apparent terminal half-life of GLPG1972
Time frame: From pre-dose (period 1) until 6 days after the last dose (period 3)
To study the pharmacokinetics of 600 mg GLPG1972 administered as oral liquid solution or as oral tablet after overnight fasting or administered as oral tablet after a high-fat high calorie breakfast
The number of adverse events reported
Time frame: From pre-dose until the Follow up (FU) visit anticipated to take place 7-10 days after the last dose
To evaluate safety and tolerability of single oral doses of GLPG1972
Changes in clinical laboratory evaluations
Time frame: From pre-dose until the Follow up (FU) visit anticipated to take place 7-10 days after the last dose
To evaluate safety and tolerability of single oral doses of GLPG1972
Changes in vital signs
Time frame: From pre-dose until the Follow up (FU) visit anticipated to take place 7-10 days after the last dose
To evaluate safety and tolerability of single oral doses of GLPG1972
Changes in physical examination parameters
Time frame: From pre-dose until the Follow up (FU) visit anticipated to take place 7-10 days after the last dose
To evaluate safety and tolerability of single oral doses of GLPG1972
Changes in ECG parameters
Time frame: From pre-dose until the Follow up (FU) visit anticipated to take place 7-10 days after the last dose
To evaluate safety and tolerability of single oral doses of GLPG1972
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 4 Oct 2016.
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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.
Ennis Lee, MD 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 GLPG1972 600 mg oral solution fasted, GLPG1972 600 mg oral tablet fasted and GLPG1972 600 mg oral tablet fed in people with Osteoarthritis, run by Lakefront Biotherapeutics NV at 1 site in Netherlands.
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 15 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 4 Oct 2016. 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 Netherlands. 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?
Maximum observed plasma concentration (Cmax) of GLPG1972 (time frame: From pre-dose (period 1) until 6 days after the last dose (period 3)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2016.