HealthyPhase 1NCT04971746
Drug-drug Interaction Study with GLPG4716 and Nintedanib and Pirfenidone in Healthy Subjects
A Phase 1 study testing Pirfenidone, GLPG4716 and Nintedanib in people with Healthy, run by Lakefront Biotherapeutics NV at 1 site in Germany.
Trial summary
The main aim of this study is to investigate the possible effect of GLPG4716 on the pharmacokinetics (PK) of pirfenidone and nintedanib. Further aims are to investigate safety and tolerability of GLPG4716 alone or administered simultaneously with pirfenidone or nintedanib. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pirfenidone, GLPG4716 and Nintedanib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteGermany
- Study dates
- 19 Jul 2021to 9 May 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female between 18 and 55 years of age (extremes included), on the date of signing the informed consent form (ICF). Female subjects should be of non-childbearing potential.
- A body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.
- Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, electrocardiogram (ECG), and fasting clinical laboratory safety tests. Aspartate transaminase and alanine aminotransferase must be no greater than the upper limit of normal (ULN). Other clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered not clinically significant in the opinion of the investigator
- This list only includes the key inclusion criteria.
Who cannot join
- Known hypersensitivity to ingredients of GLPG4716, pirfenidone, or nintedanib or history of a significant allergic reaction to ingredients of GLPG4716, pirfenidone, or nintedanib as determined by the investigator.
- Treatment with any medication (including over-the-counter (OTC) and/or prescription medication, dietary supplements, nutraceuticals, vitamins and/or herbal supplements, and hormonal replacement therapy) except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks) in the last 2 weeks or 5 half-lives of the drug, whichever is longer, prior to the first dosing.
- This list only includes the key exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Fixed-sequence Drug-drug Interaction Study in Healthy Subjects to Evaluate the Effect of GLPG4716 on the Pharmacokinetics of Nintedanib and Pirfenidone
The main aim of this study is to investigate the possible effect of GLPG4716 on the pharmacokinetics (PK) of pirfenidone and nintedanib. Further aims are to investigate safety and tolerability of GLPG4716 alone or administered simultaneously with pirfenidone or nintedanib.
- Conditions
- Healthy
- Being tested
- Pirfenidone, GLPG4716, Nintedanib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PirfenidoneDrug
On Days 1 and 13, participants will receive an oral dose of pirfenidone.
GLPG4716Drug
From Day 3 to Day 14, participants will receive GLPG4716 daily.
NintedanibDrug
On Days 1 and 13, participants will receive an oral dose of nintedanib.
| Study group | Role | What they receive |
|---|---|---|
| GLPG4716 and pirfenidone | Experimental | Not described Receives: Drug: Pirfenidone; Drug: GLPG4716 |
| GLPG4716 and nintedanib | Experimental | Not described Receives: Drug: GLPG4716; Drug: Nintedanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of pirfenidone
To determine the effect of GLPG4716 on the PK of pirfenidone
Measured: From Day 1 pre-dose until Day 15
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of pirfenidone
To determine the effect of GLPG4716 on the PK of pirfenidone
Measured: From Day 1 pre-dose until Day 15
Cmax of nintedanib
To determine the effect of GLPG4716 on the PK of nintedanib.
Measured: From Day 1 pre-dose until Day 15
AUC0-inf of nintedanib
To determine the effect of GLPG4716 on the PK of nintedanib.
Measured: From Day 1 pre-dose until Day 15
Secondary outcomes (1)
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations.
To evaluate the safety and tolerability of GLPG4716 alone or when co-administered with pirfenidone or nintedanib.
Measured: From Day 1 through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start19 Jul 2021
- Primary completion9 May 2022
- Study completion9 May 2022
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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Natalia Rueda-Rincon, MD, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971746
- Sponsor's protocol ID
- GLPG4716-CL-101
- Other IDs
- 2021-001718-12
- Status last verified
- Jun 2022
- First submitted
- 20 Jul 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Fixed-sequence Drug-drug Interaction Study in Healthy Subjects to Evaluate the Effect of GLPG4716 on the Pharmacokinetics of Nintedanib and Pirfenidone
- ClinicalTrials.gov ID
- NCT04971746
- Acronym / sponsor ID
- GLPG4716-CL-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 9 May 2022 (actual)
- Study completion
- 9 May 2022 (actual)
- First posted
- 21 Jul 2021 (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 main aim of this study is to investigate the possible effect of GLPG4716 on the pharmacokinetics (PK) of pirfenidone and nintedanib. Further aims are to investigate safety and tolerability of GLPG4716 alone or administered simultaneously with pirfenidone or nintedanib.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLPG4716 and pirfenidone | Experimental | Drug: Pirfenidone, Drug: GLPG4716 |
| GLPG4716 and nintedanib | Experimental | Drug: GLPG4716, Drug: Nintedanib |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female between 18 and 55 years of age (extremes included), on the date of signing the informed consent form (ICF). Female subjects should be of non-childbearing potential.
- A body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.
- Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, electrocardiogram (ECG), and fasting clinical laboratory safety tests. Aspartate transaminase and alanine aminotransferase must be no greater than the upper limit of normal (ULN). Other clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered not clinically significant in the opinion of the investigator
- This list only includes the key inclusion criteria.
Key exclusion criteria (3 listed)
- Known hypersensitivity to ingredients of GLPG4716, pirfenidone, or nintedanib or history of a significant allergic reaction to ingredients of GLPG4716, pirfenidone, or nintedanib as determined by the investigator.
- Treatment with any medication (including over-the-counter (OTC) and/or prescription medication, dietary supplements, nutraceuticals, vitamins and/or herbal supplements, and hormonal replacement therapy) except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks) in the last 2 weeks or 5 half-lives of the drug, whichever is longer, prior to the first dosing.
- This list only includes the key exclusion criteria.
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 |
|---|---|---|
| PirfenidoneOn Days 1 and 13, participants will receive an oral dose of pirfenidone. | Drug | GLPG4716 and pirfenidone |
| GLPG4716From Day 3 to Day 14, participants will receive GLPG4716 daily. | Drug | GLPG4716 and nintedanib, GLPG4716 and pirfenidone |
| NintedanibOn Days 1 and 13, participants will receive an oral dose of nintedanib. | Drug | GLPG4716 and nintedanib |
Primary outcome
Maximum observed plasma concentration (Cmax) of pirfenidone
Time frame: From Day 1 pre-dose until Day 15
To determine the effect of GLPG4716 on the PK of pirfenidone
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of pirfenidone
Time frame: From Day 1 pre-dose until Day 15
To determine the effect of GLPG4716 on the PK of pirfenidone
Cmax of nintedanib
Time frame: From Day 1 pre-dose until Day 15
To determine the effect of GLPG4716 on the PK of nintedanib.
AUC0-inf of nintedanib
Time frame: From Day 1 pre-dose until Day 15
To determine the effect of GLPG4716 on the PK of nintedanib.
1 secondary outcome
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations.
Time frame: From Day 1 through study completion, an average of 2 months
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 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Natalia Rueda-Rincon, 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 Pirfenidone, GLPG4716 and Nintedanib in people with Healthy, run by Lakefront Biotherapeutics NV at 1 site in Germany.
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 3 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 Sep 2024. 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 Germany. 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 pirfenidone (time frame: From Day 1 pre-dose until Day 15). The study lists 4 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 Sep 2024; AzTrials last refreshed its copy on 8 Nov 2026.