Cystic FibrosisPhase 1NCT03450720
Pharmacokinetics of GLPG2737 in Male Subjects With Cystic Fibrosis
A Phase 1 study testing GLPG2737 single dose in people with Cystic Fibrosis, run by Lakefront Biotherapeutics NV at 1 site in Belgium.
Trial summary
This is a single dose, open label study in adult male subjects with cystic fibrosis to investigate the pharmacokinetics, safety and tolerability of GLPG2737. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- GLPG2737 single dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Jun 2017to 16 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male subject ≥18 years of age on the day of signing the informed consent form (ICF).
- A confirmed clinical diagnosis of CF.
- Two mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene belonging to class I and/or class II and/or class III (documented in the subject's medical record or CF registry).
- Weight ≥40 kg.
- Exocrine pancreatic insufficiency (documented in the subject's medical record).
- Stable concomitant medication regimen for at least 2 weeks prior to study drug administration.
- Forced expiratory volume in one second (FEV1) ≥40% of predicted normal for age, gender and height at screening (pre- or postbronchodilator).
Who cannot join
- History of clinically meaningful unstable or uncontrolled chronic disease that makes the subject unsuitable for inclusion in the study in the opinion of the investigator.
- Unstable pulmonary status or respiratory tract infection (including rhinosinusitis) requiring a change in therapy within 2 weeks prior to study drug administration.
- History of hepatic cirrhosis with portal hypertension (e.g.,signs/symptoms of splenomegaly, esophageal varices).
- Use of CFTR modulator therapy (e.g., lumacaftor or ivacaftor) within 2 weeks prior to study drug administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Pharmacokinetics, Safety and Tolerability of a Single Dose of GLPG2737 Administered as Oral Suspension in Male Subjects With Cystic Fibrosis
This is a single dose, open label study in adult male subjects with cystic fibrosis to investigate the pharmacokinetics, safety and tolerability of GLPG2737.
- Conditions
- Cystic Fibrosis
- Being tested
- GLPG2737 single dose
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG2737 single doseDrug
GLPG2737 oral suspension, single dose
| Study group | Role | What they receive |
|---|---|---|
| GLPG2737 single dose. | Experimental | Single dose of GLPG2737 oral suspension. Receives: Drug: GLPG2737 single dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of GLPG2737and its metabolite.
To characterize the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.
Measured: Between day 1 pre-dose and 48 hours post-dose.
Time of occurrence of Cmax for GLPG2737(tmax)
To determine PK parameters of GLPG2737 and its metabolite after given a single oral dose in CF subjects.
Measured: Between day 1 pre-dose and 48 hours post-dose.
Plasma concentration observed at 24 hours post-dos (C24h)
To assess PK parameters of GLPG2737 and its metabolite after given a single oral dose in CF subjects.
Measured: Between day 1 pre-dose and 48 hours post-dose.
Area under the plasma concentration-time curve for GLPG2737 (AUC0-24h)
To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.
Measured: Between day 1 pre-dose and 48 hours post-dose.
Area under the plasma concentration-time curve from time zero until 48 hours post-dose (AUC0-48h)
To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.
Measured: Between day 1 pre-dose and 48 hours post-dose.
Terminal plasma elimination rate constant (ke)
To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.
Measured: Between day 1 pre-dose and 48 hours post-dose.
Apparent terminal elimination half-life ( t1/2)
To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.
Measured: Between day 1 pre-dose and 48 hours post-dose.
Secondary outcomes (1)
Number of subjects with adverse events.
To determine the safety and tolerability of GLPG2737 after a single oral dose in CF subjects.
Measured: Between screening and 15 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start28 Jun 2017
- Primary completion16 Aug 2017
- Study completion16 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Olivier Van de Steen, MD MBA, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450720
- Sponsor's protocol ID
- GLPG2737-CL-104
- Other IDs
- 2017-000449-38, 2017
- Status last verified
- Mar 2018
- First submitted
- 23 Feb 2018
- Last updated
- 19 Mar 2018
- 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 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Pharmacokinetics, Safety and Tolerability of a Single Dose of GLPG2737 Administered as Oral Suspension in Male Subjects With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT03450720
- Acronym / sponsor ID
- GLPG2737-CL-104
- Conditions
- Cystic Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2017 (actual)
- Primary completion
- 16 Aug 2017 (actual)
- Study completion
- 16 Aug 2017 (actual)
- First posted
- 1 Mar 2018 (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 is a single dose, open label study in adult male subjects with cystic fibrosis to investigate the pharmacokinetics, safety and tolerability of GLPG2737.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GLPG2737 single dose. | Experimental | Drug: GLPG2737 single doseSingle dose of GLPG2737 oral suspension. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male subject ≥18 years of age on the day of signing the informed consent form (ICF).
- A confirmed clinical diagnosis of CF.
- Two mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene belonging to class I and/or class II and/or class III (documented in the subject's medical record or CF registry).
- Weight ≥40 kg.
- Exocrine pancreatic insufficiency (documented in the subject's medical record).
Key exclusion criteria (4 listed)
- History of clinically meaningful unstable or uncontrolled chronic disease that makes the subject unsuitable for inclusion in the study in the opinion of the investigator.
- Unstable pulmonary status or respiratory tract infection (including rhinosinusitis) requiring a change in therapy within 2 weeks prior to study drug administration.
- History of hepatic cirrhosis with portal hypertension (e.g.,signs/symptoms of splenomegaly, esophageal varices).
- Use of CFTR modulator therapy (e.g., lumacaftor or ivacaftor) within 2 weeks prior to study drug administration.
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 |
|---|---|---|
| GLPG2737 single doseGLPG2737 oral suspension, single dose | Drug | GLPG2737 single dose. |
Primary outcome
Maximum observed plasma concentration (Cmax) of GLPG2737and its metabolite.
Time frame: Between day 1 pre-dose and 48 hours post-dose.
To characterize the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.
Time of occurrence of Cmax for GLPG2737(tmax)
Time frame: Between day 1 pre-dose and 48 hours post-dose.
To determine PK parameters of GLPG2737 and its metabolite after given a single oral dose in CF subjects.
Plasma concentration observed at 24 hours post-dos (C24h)
Time frame: Between day 1 pre-dose and 48 hours post-dose.
To assess PK parameters of GLPG2737 and its metabolite after given a single oral dose in CF subjects.
Area under the plasma concentration-time curve for GLPG2737 (AUC0-24h)
Time frame: Between day 1 pre-dose and 48 hours post-dose.
To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.
Area under the plasma concentration-time curve from time zero until 48 hours post-dose (AUC0-48h)
Time frame: Between day 1 pre-dose and 48 hours post-dose.
To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.
Terminal plasma elimination rate constant (ke)
Time frame: Between day 1 pre-dose and 48 hours post-dose.
To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.
Apparent terminal elimination half-life ( t1/2)
Time frame: Between day 1 pre-dose and 48 hours post-dose.
To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.
1 secondary outcome
Number of subjects with adverse events.
Time frame: Between screening and 15 days post-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 19 Mar 2018.
- 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.
Olivier Van de Steen, MD MBA 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 GLPG2737 single dose in people with Cystic Fibrosis, 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 7 inclusion and 4 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 19 Mar 2018. 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?
Maximum observed plasma concentration (Cmax) of GLPG2737and its metabolite. (time frame: Between day 1 pre-dose and 48 hours post-dose.). The study lists 7 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 19 Mar 2018.