HealthyPhase 1NCT03214614
A Study to Assess Safety, Tolerability and Pharmacokinetics of GLPG2451 in Healthy Male Subjects
A Phase 1 study testing GLPG2451 multiple dose and GLPG2451/GLPG2222 multiple dose in people with Healthy, run by Lakefront Biotherapeutics NV at 1 site in Belgium.
Trial summary
The study is a Phase I, randomized, double-blind, placebo-controlled study evaluating multiple ascending oral doses of GLPG2451 and the combination of GLPG2451 and GLPG2222 given for 14 days in healthy male subjects. 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?
- GLPG2451 multiple dose and GLPG2451/GLPG2222 multiple dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Nov 2016to 25 Aug 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 and 50 years of age inclusive, on the date of signing the Informed Consent Form (ICF).
- A body mass index (BMI) between 18-30 kg/m2, inclusive.
- 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 clinical safety laboratory tests prior to the initial study drug administration. Clinical safety laboratory test results must be within the laboratory reference ranges or test results that are outside the reference ranges need to be considered non clinically significant in the opinion of the investigator. One retest is allowed during screening period, if deemed appropriate by the investigator.
- Liver function tests must meet the following criteria: a. Aspartate aminotransferase (AST), ALT, or alkaline phosphatase (ALP) <1.5x ULN.
- Bilirubin not greater than ULN, however documented Gilbert's syndrome is acceptable but no more than one subject with confirmed Gilbert's syndrome is allowed per cohort. One retest is allowed during screening period, if deemed appropriate by the investigator.
- Able and willing to comply with restrictions on prior and concomitant medication as described in the protocol.
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- Non-smokers and non-users of any nicotine-containing products. A non-smoker is defined as an individual who has abstained from smoking for at least 1 year prior to screening. A non-user is defined as an individual who has abstained from any nicotine containing products for at least 1 year prior to the screening.
- Negative urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, methadone, and tricyclic antidepressants) and negative alcohol breath test.
- No evidence of lens opacity on slit lamp examination or similar system (e.g. ITrace technology).
- Agree to the use of a highly effective method of contraception (see protocol).
- Able and willing to sign the ICF as approved by the IEC, prior to any screening evaluations and willing to adhere to predefined prohibitions and restrictions.
Who cannot join
- Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the investigator, such as anaphylaxis requiring hospitalization.
- Positive serology for hepatitis B virus surface antigen (HBs Ag), hepatitis C virus (HCV), or history of hepatitis from any cause with the exception of hepatitis A.
- History of or a current immunosuppressive condition (e.g., human immunodeficiency virus [HIV] infection).
- Clinically significant illness in the 3 months before the initial study drug administration.
- Presence or sequelae of gastrointestinal, liver, kidney (creatinine clearance ≤80 mL/min using the Cockcroft-Gault formula; if calculated result ≤80 mL/min, a 24-hour urine collection to determine actual value can be performed) 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 and with no evidence of recurrence).
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- Treatment with any drug known to have a well-defined potential for toxicity to a major organ in the last 3 months of 5 half-lives of the drug (whichever is the longer) before the initial study drug administration.
- Active drug or alcohol abuse (more than 3 glasses of wine or beer or equivalent/day) within 2 years prior to the initial study drug administration.
- Participation in a drug, drug-device combination or biologic investigational research study within 12 weeks or 5 half-lives of the investigational drug (whichever is the longer) prior to initial study drug administration.
- 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: Assessment of Safety, Tolerability and Pharmacokinetics of Multiple Ascending Oral Doses of GLPG2451 and of the Combination of GLPG2451 and GLPG2222 in Healthy Male Subjects
The study is a Phase I, randomized, double-blind, placebo-controlled study evaluating multiple ascending oral doses of GLPG2451 and the combination of GLPG2451 and GLPG2222 given for 14 days in healthy male subjects.
The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses of GLPG2451 given to healthy male subjects compared to placebo, as well as of multiple oral doses of the combination of GLPG2451/GLPG2222 compared to placebo.
- Conditions
- Healthy
- Being tested
- GLPG2451 multiple dose, Placebo multiple dose, GLPG2451/GLPG2222 multiple dose, Combined Placebo multiple dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG2451 multiple doseDrug
GLPG2451 oral suspension, multiple ascending doses, daily for 14 days
Placebo multiple doseDrug
Placebo, oral suspension, daily for 14 days
GLPG2451/GLPG2222 multiple doseDrug
GLPG2451 oral suspension and GLPG2222 oral suspension, multiple doses, daily for 14 days
Combined Placebo multiple doseDrug
Combined Placebo, oral suspension, daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| GLPG2451 multiple dose | Experimental | Multiple doses of GLPG2451 oral suspension at up to 3 dose levels in ascending order Receives: Drug: GLPG2451 multiple dose |
| Placebo multiple dose | Placebo comparator | Multiple doses of Placebo oral suspension Receives: Drug: Placebo multiple dose |
| GLPG2451/GLPG2222 | Experimental | Multiple doses of GLPG2451 oral suspension combined GLPG2222 oral suspension at up to 2 dose levels Receives: Drug: GLPG2451/GLPG2222 multiple dose |
| Combined Placebo multiple dose | Placebo comparator | Multiple doses of Combined Placebo oral suspension Receives: Drug: Combined Placebo multiple dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change versus placebo in the proportion of subjects with adverse events
To assess safety and tolerability of multiple ascending doses and combination of GLPG2451 with GLPG2222 versus placebo in healthy subjects
Measured: Between screening and 154 days after the last dose
Secondary outcomes (4)
Maximum observed plasma concentration of GLPG2451 (Cmax) given alone or in combination with GLPG2222
To characterize the pharmacokinetics of GLPG2451 and its metabolite after multiple oral doses in healthy subjects
Measured: Between screening and 154 days after the last dose
Time of occurrence of Cmax for GLPG2451 given alone or in combination with GLPG2222
To characterize the pharmacokinetics of GLPG2451and its metabolite after multiple oral doses in healthy subjects
Measured: Between screening and 154 days after the last dose
Area under the plasma concentration-time curve of GLPG2451 (AUC0-t) given alone or in combination with GLPG2222
To characterize the pharmacokinetics of GLPG2451 and its metabolite after multiple oral doses in healthy subjects
Measured: Between screening and 154 days after the last dose
Ratio of 4-beta-hydroxycholesterol/cholesterol in plasma after multiple oral doses in healthy subjects
To explore the potential of CYP3A4 interaction with GLPG2451
Measured: Day 1 predose and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start14 Nov 2016
- Primary completion25 Aug 2017
- Study completion25 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chris Brearley, MD, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214614
- Sponsor's protocol ID
- GLPG2451-CL-105
- Status last verified
- Sep 2017
- First submitted
- 10 Jul 2017
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety, Tolerability and Pharmacokinetics of Multiple Ascending Oral Doses of GLPG2451 and of the Combination of GLPG2451 and GLPG2222 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03214614
- Acronym / sponsor ID
- GLPG2451-CL-105
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2016 (actual)
- Primary completion
- 25 Aug 2017 (actual)
- Study completion
- 25 Aug 2017 (actual)
- First posted
- 11 Jul 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.
The study is a Phase I, randomized, double-blind, placebo-controlled study evaluating multiple ascending oral doses of GLPG2451 and the combination of GLPG2451 and GLPG2222 given for 14 days in healthy male subjects.
The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses of GLPG2451 given to healthy male subjects compared to placebo, as well as of multiple oral doses of the combination of GLPG2451/GLPG2222 compared to placebo.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GLPG2451 multiple dose | Experimental | Drug: GLPG2451 multiple doseMultiple doses of GLPG2451 oral suspension at up to 3 dose levels in ascending order |
| Placebo multiple dose | Placebo comparator | Drug: Placebo multiple doseMultiple doses of Placebo oral suspension |
| GLPG2451/GLPG2222 | Experimental | Drug: GLPG2451/GLPG2222 multiple doseMultiple doses of GLPG2451 oral suspension combined GLPG2222 oral suspension at up to 2 dose levels |
| Combined Placebo multiple dose | Placebo comparator | Drug: Combined Placebo multiple doseMultiple doses of Combined Placebo oral suspension |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male between 18 and 50 years of age inclusive, on the date of signing the Informed Consent Form (ICF).
- A body mass index (BMI) between 18-30 kg/m2, inclusive.
- 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 clinical safety laboratory tests prior to the initial study drug administration. Clinical safety laboratory test results must be within the laboratory reference ranges or test results that are outside the reference ranges need to be considered non clinically significant in the opinion of the investigator. One retest is allowed during screening period, if deemed appropriate by the investigator.
- Liver function tests must meet the following criteria: a. Aspartate aminotransferase (AST), ALT, or alkaline phosphatase (ALP) <1.5x ULN.
- Able and willing to comply with restrictions on prior and concomitant medication as described in the protocol.
Key exclusion criteria (10 listed)
- Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the investigator, such as anaphylaxis requiring hospitalization.
- Positive serology for hepatitis B virus surface antigen (HBs Ag), hepatitis C virus (HCV), or history of hepatitis from any cause with the exception of hepatitis A.
- History of or a current immunosuppressive condition (e.g., human immunodeficiency virus [HIV] infection).
- Clinically significant illness in the 3 months before the initial study drug administration.
- Presence or sequelae of gastrointestinal, liver, kidney (creatinine clearance ≤80 mL/min using the Cockcroft-Gault formula; if calculated result ≤80 mL/min, a 24-hour urine collection to determine actual value can be performed) 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 |
|---|---|---|
| GLPG2451 multiple doseGLPG2451 oral suspension, multiple ascending doses, daily for 14 days | Drug | GLPG2451 multiple dose |
| Placebo multiple dosePlacebo, oral suspension, daily for 14 days | Drug | Placebo multiple dose |
| GLPG2451/GLPG2222 multiple doseGLPG2451 oral suspension and GLPG2222 oral suspension, multiple doses, daily for 14 days | Drug | GLPG2451/GLPG2222 |
| Combined Placebo multiple doseCombined Placebo, oral suspension, daily for 14 days | Drug | Combined Placebo multiple dose |
Primary outcome
Change versus placebo in the proportion of subjects with adverse events
Time frame: Between screening and 154 days after the last dose
To assess safety and tolerability of multiple ascending doses and combination of GLPG2451 with GLPG2222 versus placebo in healthy subjects
4 secondary outcomes
Maximum observed plasma concentration of GLPG2451 (Cmax) given alone or in combination with GLPG2222
Time frame: Between screening and 154 days after the last dose
Time of occurrence of Cmax for GLPG2451 given alone or in combination with GLPG2222
Time frame: Between screening and 154 days after the last dose
Area under the plasma concentration-time curve of GLPG2451 (AUC0-t) given alone or in combination with GLPG2222
Time frame: Between screening and 154 days after the last dose
Ratio of 4-beta-hydroxycholesterol/cholesterol in plasma after multiple oral doses in healthy subjects
Time frame: Day 1 predose and Day 14
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 13 Sep 2017.
- 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.
Chris Brearley, 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 GLPG2451 multiple dose and GLPG2451/GLPG2222 multiple dose 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 11 inclusion and 10 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 13 Sep 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. Some participants in this study may receive a placebo. 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?
Change versus placebo in the proportion of subjects with adverse events (time frame: Between screening and 154 days after the last dose). 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 13 Sep 2017.