HealthyPhase 1NCT02788721
A Study to Assess Safety, Tolerability and Pharmacokinetics of GLPG2451 in Healthy Female Subjects
A Phase 1 study testing GLPG2451 single dose in people with Healthy, run by Lakefront Biotherapeutics NV at 1 site in Belgium.
Trial summary
The study is a First-in-Human, Phase I, randomized, double-blind, placebo-controlled study evaluating single and multiple ascending oral doses of GLPG2451 and combined multiple doses of GLPG2451 and GLPG2222 in healthy female subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- GLPG2451 single dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Apr 2016to 27 Apr 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female between 18-65 years of age inclusive, on the day of signing informed consent form (ICF).
- Of non-childbearing potential defined as surgically sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy), or post-menopausal (at least 12 consecutive months without menstruation, without an alternative medical cause [including hormone replacement therapy]). In addition a determination of follicle stimulating hormone (FSH) can be performed with FSH >35 mIU/ml to further confirm postmenopausal status without menstruation for ≥12 months.
- 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 electrocardiogram (ECG), Holter monitoring and a laboratory profile prior to the initial study drug administration.
- Discontinuation of all medications (including over-the-counter medications and herbal supplements) except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks) at least 2 weeks prior to the first study drug administration. In addition, subjects must agree not to take any medications (including over-the-counter medication and herbal supplements), or alcohol during the course of the study.-non-smokers and non-users of any nicotine-containing products.
- 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 the 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 drug screen (amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, methadone, and tricyclic antidepressants) and alcohol breath test.
- Able and willing to sign the ICF as approved by the IEC, prior to screening evaluations, and willing to adhere to the prohibitions and restrictions.
Who cannot join
- Known hypersensitivity 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 (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 (e.g., human immunodeficiency virus [HIV] infection).
- Symptoms of clinically significant illness in the 3 months before the initial study drug administration.
- Presence or having sequelae of gastrointestinal, liver or kidney (creatinine clearance ≤ 80 mL/min using the Cockroft formula; if calculated result ≤ 80 mL/min, a 24-hour urine collection to determine actual value can be done) 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 or carcinoma in situ of the cervix that has been treated with no evidence of recurrence).
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- Clinically relevant abnormalities detected on ECG and/or Holter regarding either rhythm or conduction (e.g. QTcF ≥ 470 msec, or a known long QT syndrome). A first degree heart block will not be considered as a significant abnormality.
- Family history (if known) of long QT syndrome in a primary relative.
- Clinically relevant abnormalities detected on vital signs.
- Significant blood loss (including blood donation [> 500 mL]), or having had a transfusion of any blood product within 12 weeks prior to the initial study drug administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Oral Doses of GLPG2451 and of the Combination of GLPG2451 and GLPG2222 in Healthy Female Subjects
The study is a First-in-Human, Phase I, randomized, double-blind, placebo-controlled study evaluating single and multiple ascending oral doses of GLPG2451 and combined multiple doses of GLPG2451 and GLPG2222 in healthy female subjects. The purpose of the study is to evaluate safety and tolerability after single ascending oral doses and of multiple doses of GLPG2451 given to healthy female subjects compared to placebo as well as of multiple doses of the combination of GLPG2451/GLPG2222 compared to GLPG2451/placebo.
- Conditions
- Healthy
- Being tested
- GLPG2451 single dose, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG2451 single doseDrug
GLPG2451 oral suspension, single ascending doses, daily
PlaceboDrug
Placebo, oral suspension, daily
| Study group | Role | What they receive |
|---|---|---|
| GLPG2451 single dose | Experimental | Single dose of GLPG2451 oral suspension at up to 4 dose levels in ascending order Receives: Drug: GLPG2451 single dose |
| Placebo single dose | Placebo comparator | Single dose of Placebo oral suspension Receives: Drug: Placebo |
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 single ascending doses with GLPG2451 versus placebo in healthy subjects
Measured: Between screening and 182 days after the last dose
Secondary outcomes (3)
Maximum observed plasma concentration of GLPG2451 (Cmax) given alone
To characterize pharmacokinetics of GLPG2451 and its metabolite after a single oral dose in healthy subjects
Measured: Between day 1 predose and 175 days after the last dose
Time of occurrence of Cmax for GLPG2451 and (tmax) given alone
To characterize pharmacokinetics of GLPG2451 and its metabolite after a single oral dose in healthy subjects
Measured: Between day 1 predose and 175 days after the last dose
Area under the plasma concentration-time curve (AUC0-t) of GLPG2451 given alone
To characterize pharmacokinetics of GLPG2451 and its metabolite after a single oral dose in healthy subjects
Measured: Between day 1 predose and 175 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 posted2 Jun 2016 (estimated)
- Study start14 Apr 2016
- Primary completion27 Apr 2017
- Study completion27 Apr 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pharmaceutical Research Associates, SGS S.A.
- Responsible party
- Sponsor
- Investigators
- Chris Brearley, MD, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788721
- Sponsor's protocol ID
- GLPG2451-CL-101
- Status last verified
- Jul 2017
- First submitted
- 13 May 2016
- Last updated
- 12 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Oral Doses of GLPG2451 and of the Combination of GLPG2451 and GLPG2222 in Healthy Female Subjects
- ClinicalTrials.gov ID
- NCT02788721
- Acronym / sponsor ID
- GLPG2451-CL-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Collaborators
- Pharmaceutical Research Associates, SGS S.A.
- Study start
- 14 Apr 2016 (actual)
- Primary completion
- 27 Apr 2017 (actual)
- Study completion
- 27 Apr 2017 (actual)
- First posted
- 2 Jun 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.
The study is a First-in-Human, Phase I, randomized, double-blind, placebo-controlled study evaluating single and multiple ascending oral doses of GLPG2451 and combined multiple doses of GLPG2451 and GLPG2222 in healthy female subjects. The purpose of the study is to evaluate safety and tolerability after single ascending oral doses and of multiple doses of GLPG2451 given to healthy female subjects compared to placebo as well as of multiple doses of the combination of GLPG2451/GLPG2222 compared to GLPG2451/placebo.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLPG2451 single dose | Experimental | Drug: GLPG2451 single doseSingle dose of GLPG2451 oral suspension at up to 4 dose levels in ascending order |
| Placebo single dose | Placebo comparator | Drug: PlaceboSingle dose of Placebo oral suspension |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female between 18-65 years of age inclusive, on the day of signing informed consent form (ICF).
- Of non-childbearing potential defined as surgically sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy), or post-menopausal (at least 12 consecutive months without menstruation, without an alternative medical cause [including hormone replacement therapy]). In addition a determination of follicle stimulating hormone (FSH) can be performed with FSH >35 mIU/ml to further confirm postmenopausal status without menstruation for ≥12 months.
- 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 electrocardiogram (ECG), Holter monitoring and a laboratory profile prior to the initial study drug administration.
- Discontinuation of all medications (including over-the-counter medications and herbal supplements) except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks) at least 2 weeks prior to the first study drug administration. In addition, subjects must agree not to take any medications (including over-the-counter medication and herbal supplements), or alcohol during the course of the study.-non-smokers and non-users of any nicotine-containing products.
Key exclusion criteria (10 listed)
- Known hypersensitivity 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 (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 (e.g., human immunodeficiency virus [HIV] infection).
- Symptoms of clinically significant illness in the 3 months before the initial study drug administration.
- Presence or having sequelae of gastrointestinal, liver or kidney (creatinine clearance ≤ 80 mL/min using the Cockroft formula; if calculated result ≤ 80 mL/min, a 24-hour urine collection to determine actual value can be done) 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 single doseGLPG2451 oral suspension, single ascending doses, daily | Drug | GLPG2451 single dose |
| PlaceboPlacebo, oral suspension, daily | Drug | Placebo single dose |
Primary outcome
Change versus placebo in the proportion of subjects with adverse events
Time frame: Between screening and 182 days after the last dose
To assess safety and tolerability of single ascending doses with GLPG2451 versus placebo in healthy subjects
3 secondary outcomes
Maximum observed plasma concentration of GLPG2451 (Cmax) given alone
Time frame: Between day 1 predose and 175 days after the last dose
Time of occurrence of Cmax for GLPG2451 and (tmax) given alone
Time frame: Between day 1 predose and 175 days after the last dose
Area under the plasma concentration-time curve (AUC0-t) of GLPG2451 given alone
Time frame: Between day 1 predose and 175 days after the last dose
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 12 Jul 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 single 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 8 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 12 Jul 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 182 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 12 Jul 2017.