Cystic FibrosisPhase 1NCT03589313
Pharmacokinetics of GLPG3067 in Male Subjects With Cystic Fibrosis.
A Phase 1 study testing GLPG3067 single dose in people with Cystic Fibrosis, run by Lakefront Biotherapeutics NV at 1 site in Belgium.
Trial summary
This clinical study is a Phase I, open-label, single-center study designed to evaluate the pharmacokinetics profile of a single oral dose of GLPG3067 in adult male subjects with cystic fibrosis in fed state. 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?
- GLPG3067 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
- 12 Feb 2018to 26 Mar 2018
- 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 ICF.
- A confirmed clinical diagnosis of CF.
- Exocrine pancreatic insufficiency (documented in the subject's medical record).
- Stable concomitant medication regimen for pulmonary health for at least 2 weeks prior to study drug administration
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.
- Need for supplemental oxygen during the day, and >2 L/minute while sleeping.
- History of solid organ or hematopoietic cell transplantation.
- 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.
- Abnormal liver function test at screening, defined as aspartate aminotransferase (AST) and/or ALT and/or alkaline phosphatase and/or gamma-glutamyl transferase (GGT) ≥3x the upper limit of normal, and/or total bilirubin ≥1.5x the upper limit of normal.
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 GLPG3067 Administered as Solid Formulation in Male Subjects With Cystic Fibrosis.
This clinical study is a Phase I, open-label, single-center study designed to evaluate the pharmacokinetics profile of a single oral dose of GLPG3067 in adult male subjects with cystic fibrosis in fed state.
- Conditions
- Cystic Fibrosis
- Being tested
- GLPG3067 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.
GLPG3067 single doseDrug
GLPG3067 film coated tablets provided at Day 1.
| Study group | Role | What they receive |
|---|---|---|
| GLPG3067 single dose. | Experimental | Single Dose of GLPG3067 film coated tablets. Receives: Drug: GLPG3067 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 GLPG3067 single dose.
To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067.
Measured: Between Day 1 pre-dose and Day 4.
Area under the plasma concentration-time curve from time zero until 24 hours post-dose ( (AUC0-24h) of GLPG3067 single dose.
To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067.
Measured: Between Day 1 pre-dose and Day 4.
Area under the plasma concentration-time curve from time zero until 72 hours post-dose (AUC0-72h) of GLPG3067 single dose.
To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067.
Measured: Between Day 1 pre-dose and Day 4.
Secondary outcomes (1)
The number of subjects with adverse events.
To evaluate the safety and tolerability of a single oral dose of GLPG3067 in adult male subjects with CF.
Measured: From screening to 19 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 posted17 Jul 2018
- Study start12 Feb 2018
- Primary completion26 Mar 2018
- Study completion26 Mar 2018
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
- NCT03589313
- Sponsor's protocol ID
- GLPG3067-CL-104
- Other IDs
- 2017-002294-19, 2017
- Status last verified
- Jul 2018
- First submitted
- 9 Jul 2018
- Last updated
- 17 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 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 GLPG3067 Administered as Solid Formulation in Male Subjects With Cystic Fibrosis.
- ClinicalTrials.gov ID
- NCT03589313
- Acronym / sponsor ID
- GLPG3067-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
- 12 Feb 2018 (actual)
- Primary completion
- 26 Mar 2018 (actual)
- Study completion
- 26 Mar 2018 (actual)
- First posted
- 17 Jul 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 clinical study is a Phase I, open-label, single-center study designed to evaluate the pharmacokinetics profile of a single oral dose of GLPG3067 in adult male subjects with cystic fibrosis in fed state.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GLPG3067 single dose. | Experimental | Drug: GLPG3067 single doseSingle Dose of GLPG3067 film coated tablets. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male subject ≥18 years of age on the day of signing the ICF.
- A confirmed clinical diagnosis of CF.
- Exocrine pancreatic insufficiency (documented in the subject's medical record).
- Stable concomitant medication regimen for pulmonary health for at least 2 weeks prior to study drug administration
Key exclusion criteria (7 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.
- Need for supplemental oxygen during the day, and >2 L/minute while sleeping.
- History of solid organ or hematopoietic cell transplantation.
- History of hepatic cirrhosis with portal hypertension (e.g., signs/symptoms of splenomegaly, esophageal varices).
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 |
|---|---|---|
| GLPG3067 single doseGLPG3067 film coated tablets provided at Day 1. | Drug | GLPG3067 single dose. |
Primary outcome
Maximum observed plasma concentration (cmax) of GLPG3067 single dose.
Time frame: Between Day 1 pre-dose and Day 4.
To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067.
Area under the plasma concentration-time curve from time zero until 24 hours post-dose ( (AUC0-24h) of GLPG3067 single dose.
Time frame: Between Day 1 pre-dose and Day 4.
To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067.
Area under the plasma concentration-time curve from time zero until 72 hours post-dose (AUC0-72h) of GLPG3067 single dose.
Time frame: Between Day 1 pre-dose and Day 4.
To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067.
1 secondary outcome
The number of subjects with adverse events.
Time frame: From screening to 19 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 17 Jul 2018.
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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 GLPG3067 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 4 inclusion and 7 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 17 Jul 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 GLPG3067 single dose. (time frame: Between Day 1 pre-dose and Day 4.). 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?
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 17 Jul 2018.