HealthyPhase 1NCT06647810

A Study in Healthy People to Test How 2 Different Formulations of BI 690517 Are Taken up in the Body and How Probenecid Influences the Amount of BI 690517 in the Blood

A Phase 1 study testing BI 690517 formulation 1, BI 690517 formulation 2 and Probenecid in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This trial aims to test how two different formulations of BI 690517 are taken up by the body and how probenecid influences the amount of BI 690517 in the blood. 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?: BI 690517 formulation 1, BI 690517 formulation 2 and Probenecid
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteGermany
Study dates: 13 Nov 2024to 7 Jan 2025
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

Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 55 years (inclusive)
Body mass index (BMI) of 18.5 to 29.9 kg/m² (inclusive)
Signed and dated written informed consent m accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial Further inclusion criteria apply.

Who cannot join

Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm (beats per minute)
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Humanpharmakologisches Zentrum Biberach
Biberach, 88397

Other trials in Germany

About this study

Official title: Relative Bioavailability of Two Different BI 690517 Formulations as Well as the Effect of Multiple Doses of Probenecid on the Single Dose Pharmacokinetics of BI 690517 Following Oral Administration in Healthy Male and Female Subjects (a Randomised, Open-label, Three-way Crossover Trial)

This trial aims to test how two different formulations of BI 690517 are taken up by the body and how probenecid influences the amount of BI 690517 in the blood.

Conditions: Healthy
Being tested: BI 690517 formulation 1, BI 690517 formulation 2, Probenecid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BI 690517 formulation 1Drug
Also called Vicadrostat
BI 690517 formulation 1
BI 690517 formulation 2Drug
Also called Vicadrostat
BI 690517 formulation 2
ProbenecidDrug
Also called Probenecid Biokanol®
Probenecid

Study groups in NCT06647810
Study group	Role	What they receive
BI 690517 formulation 1, then BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2	Experimental	Not described Receives: Drug: BI 690517 formulation 1; Drug: BI 690517 formulation 2; Drug: Probenecid
BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1	Experimental	Not described Receives: Drug: BI 690517 formulation 1; Drug: BI 690517 formulation 2; Drug: Probenecid
Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1, then BI 690517 formulation 2	Experimental	Not described Receives: Drug: BI 690517 formulation 1; Drug: BI 690517 formulation 2; Drug: Probenecid

What is being measured

The primary outcome is the main question the study is designed to answer.

AUC0-tz (area under the concentration-time curve of BI 690517 in plasma over the time interval from 0 to the last quantifiable data point)
For the relative bioavailability of BI 690517.
Measured: Up to day 3.
Cmax (maximum measured concentration of BI 690517 in plasma)
For the relative bioavailability of BI 690517.
Measured: Up to day 3.
AUC0-∞ (area under the concentration-time curve of BI 690517 in plasma over the time interval from 0 extrapolated to infinity)
For the drug interaction of BI 690517 with probenecid.
Measured: Up to day 3.
Cmax (maximum measured concentration of BI 690517 in plasma)
For the drug interaction of BI 690517 with probenecid.
Measured: Up to day 3.

Secondary outcomes (2)

AUC0-∞ (area under the concentration-time curve of BI 690517 in plasma over the time interval from 0 extrapolated to infinity)
For the relative bioavailability of BI 690517.
Measured: Up to day 3.
AUC0-tz (area under the concentration-time curve of BI 690517 in plasma over the time interval from 0 to the last quantifiable data point)
For the drug interaction of BI 690517 with probenecid.
Measured: Up to day 3.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Nov 20247 Jan 2025

First posted18 Oct 2024
Study start13 Nov 2024
Primary completion12 Dec 2024
Study completion7 Jan 2025

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.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
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: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06647810
Sponsor's protocol ID: 1378-0025
Other IDs: 2024-513590-45-00, U1111-1307-2145
Status last verified: Jan 2025
First submitted: 17 Oct 2024
Last updated: 9 Jan 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relative Bioavailability of Two Different BI 690517 Formulations as Well as the Effect of Multiple Doses of Probenecid on the Single Dose Pharmacokinetics of BI 690517 Following Oral Administration in Healthy Male and Female Subjects (a Randomised, Open-label, Three-way Crossover Trial)
ClinicalTrials.gov ID: NCT06647810
Acronym / sponsor ID: 1378-0025
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 13 Nov 2024 (actual)
Primary completion: 12 Dec 2024 (actual)
Study completion: 7 Jan 2025 (actual)
First posted: 18 Oct 2024 (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 trial aims to test how two different formulations of BI 690517 are taken up by the body and how probenecid influences the amount of BI 690517 in the blood.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
BI 690517 formulation 1, then BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2	Experimental	Drug: BI 690517 formulation 1, Drug: BI 690517 formulation 2, Drug: Probenecid
BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1	Experimental	Drug: BI 690517 formulation 1, Drug: BI 690517 formulation 2, Drug: Probenecid
Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1, then BI 690517 formulation 2	Experimental	Drug: BI 690517 formulation 1, Drug: BI 690517 formulation 2, Drug: Probenecid

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 55 years (inclusive)
Body mass index (BMI) of 18.5 to 29.9 kg/m² (inclusive)
Signed and dated written informed consent m accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial Further inclusion criteria apply.

Key exclusion criteria (4 listed)

Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm (beats per minute)
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.

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
BI 690517 formulation 1Also: VicadrostatBI 690517 formulation 1	Drug	BI 690517 formulation 1, then BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2, BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1, Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1, then BI 690517 formulation 2
BI 690517 formulation 2Also: VicadrostatBI 690517 formulation 2	Drug	BI 690517 formulation 1, then BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2, BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1, Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1, then BI 690517 formulation 2
ProbenecidAlso: Probenecid Biokanol®Probenecid	Drug	BI 690517 formulation 1, then BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2, BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1, Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1, then BI 690517 formulation 2

Primary outcome

AUC0-tz (area under the concentration-time curve of BI 690517 in plasma over the time interval from 0 to the last quantifiable data point)
Time frame: Up to day 3.
For the relative bioavailability of BI 690517.
Cmax (maximum measured concentration of BI 690517 in plasma)
Time frame: Up to day 3.
For the relative bioavailability of BI 690517.
AUC0-∞ (area under the concentration-time curve of BI 690517 in plasma over the time interval from 0 extrapolated to infinity)
Time frame: Up to day 3.
For the drug interaction of BI 690517 with probenecid.
Cmax (maximum measured concentration of BI 690517 in plasma)
Time frame: Up to day 3.
For the drug interaction of BI 690517 with probenecid.

2 secondary outcomes

AUC0-∞ (area under the concentration-time curve of BI 690517 in plasma over the time interval from 0 extrapolated to infinity)
Time frame: Up to day 3.
AUC0-tz (area under the concentration-time curve of BI 690517 in plasma over the time interval from 0 to the last quantifiable data point)
Time frame: Up to day 3.

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 9 Jan 2025.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Related trials for Healthy

Not yet recruitingObservational study
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Not yet recruitingPhase 1
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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.

The record lists no contact. Use the official record to reach the sponsor.

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 BI 690517 formulation 1, BI 690517 formulation 2 and Probenecid in people with Healthy, run by Boehringer Ingelheim 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 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 9 Jan 2025. 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?

AUC0-tz (area under the concentration-time curve of BI 690517 in plasma over the time interval from 0 to the last quantifiable data point) (time frame: Up to day 3.). 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?

On the ClinicalTrials.gov record for NCT06647810.

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 9 Jan 2025.