HealthyPhase 1NCT05515588
A Study in Healthy Men to Test How BI 690517 is Taken up and Handled by the Body
A Phase 1 study testing BI 690517 (C-14) and BI 690517 in people with Healthy, run by Boehringer Ingelheim at 1 site in Netherlands.
Trial summary
The trial is intended to investigate the basic pharmacokinetics, excretion pathways and metabolism of BI 690517 and its metabolites. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 690517 (C-14) and BI 690517
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 Sep 2022to 17 Nov 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male 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 in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
Who cannot join
- Subjects will not be allowed to participate, if any of the following general criteria apply:
- 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 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 45 to 90 mmHg, or pulse rate outside the range of 40 to 100 beats per minute (bpm).
- 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.
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
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- Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair).
- Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders.
- History of relevant orthostatic hypotension (including but not limited to a reduction in systolic BP of ≥20 mm Hg or in diastolic BP of ≥10 mm Hg within 3 minutes of standing during screening measurement associated with clinical symptoms), fainting spells, or blackouts.
- Further exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-label Trial to Investigate Metabolism, Pharmacokinetics (Following a Mass Balance Design) and Absolute Bioavailability of BI 690517 (C-14) After Oral and Intravenous Administration in Healthy Male Subjects
The trial is intended to investigate the basic pharmacokinetics, excretion pathways and metabolism of BI 690517 and its metabolites.
- Conditions
- Healthy
- Being tested
- BI 690517 (C-14), BI 690517
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 690517 (C-14)Drug
Also called Vicadrostat
BI 690517 (C-14)
BI 690517Drug
Also called Vicadrostat
BI 690517
| Study group | Role | What they receive |
|---|---|---|
| Part A: BI 690517 (C-14) | Experimental | Not described Receives: Drug: BI 690517 (C-14) |
| Part B: BI 690517 fasted (test treatment, T) / BI 690517 (C-14) (reference treatment, R) | Experimental | Not described Receives: Drug: BI 690517 (C-14); Drug: BI 690517 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Fraction of [14C] radioactivity excreted into urine given as percentage of the administered dose in the time interval from 0 to last quantifiable time point (fe urine,0-tz )
Measured: Up to 22 days.
Part A: Fraction of [14C] radioactivity excreted into feces given as percentage of the administered dose in the time interval from 0 to last quantifiable time point (fe feces, 0-tz)
Measured: Up to 22 days.
Part B: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after intravenous administration (AUC0-∞)
Measured: Up to 3 days.
Part B: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after oral administration (AUC0-∞)
Measured: Up to 3 days.
Secondary outcomes (4)
Part A: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz)
Measured: Up to 8 days.
Part A: Maximum measured concentration of the analyte in plasma (Cmax)
Measured: Up to 8 days.
Part B: Maximum measured concentration of the analyte in plasma (Cmax)
Measured: Up to 3 days.
Part B: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz)
Measured: Up to 3 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start19 Sep 2022
- Primary completion17 Nov 2022
- Study completion17 Nov 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.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515588
- Sponsor's protocol ID
- 1378-0013
- Other IDs
- 2022-001818-18
- Status last verified
- Sep 2024
- First submitted
- 24 Aug 2022
- Last updated
- 20 Sep 2024
- Results posted
- 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label Trial to Investigate Metabolism, Pharmacokinetics (Following a Mass Balance Design) and Absolute Bioavailability of BI 690517 (C-14) After Oral and Intravenous Administration in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT05515588
- Acronym / sponsor ID
- 1378-0013
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 17 Nov 2022 (actual)
- Study completion
- 17 Nov 2022 (actual)
- First posted
- 25 Aug 2022 (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 trial is intended to investigate the basic pharmacokinetics, excretion pathways and metabolism of BI 690517 and its metabolites.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: BI 690517 (C-14) | Experimental | Drug: BI 690517 (C-14) |
| Part B: BI 690517 fasted (test treatment, T) / BI 690517 (C-14) (reference treatment, R) | Experimental | Drug: BI 690517 (C-14), Drug: BI 690517 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male 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 in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
Key exclusion criteria (10 listed)
- Subjects will not be allowed to participate, if any of the following general criteria apply:
- 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 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 45 to 90 mmHg, or pulse rate outside the range of 40 to 100 beats per minute (bpm).
- 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.
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 (C-14)Also: VicadrostatBI 690517 (C-14) | Drug | Part A: BI 690517 (C-14), Part B: BI 690517 fasted (test treatment, T) / BI 690517 (C-14) (reference treatment, R) |
| BI 690517Also: VicadrostatBI 690517 | Drug | Part B: BI 690517 fasted (test treatment, T) / BI 690517 (C-14) (reference treatment, R) |
Primary outcome
Part A: Fraction of [14C] radioactivity excreted into urine given as percentage of the administered dose in the time interval from 0 to last quantifiable time point (fe urine,0-tz )
Time frame: Up to 22 days.
Part A: Fraction of [14C] radioactivity excreted into feces given as percentage of the administered dose in the time interval from 0 to last quantifiable time point (fe feces, 0-tz)
Time frame: Up to 22 days.
Part B: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after intravenous administration (AUC0-∞)
Time frame: Up to 3 days.
Part B: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after oral administration (AUC0-∞)
Time frame: Up to 3 days.
4 secondary outcomes
Part A: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz)
Time frame: Up to 8 days.
Part A: Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: Up to 8 days.
Part B: Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: Up to 3 days.
Part B: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz)
Time frame: Up to 3 days.
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 20 Sep 2024.
- 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
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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 (C-14) and BI 690517 in people with Healthy, run by Boehringer Ingelheim at 1 site in Netherlands.
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 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 20 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 Netherlands. 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?
Part A: Fraction of [14C] radioactivity excreted into urine given as percentage of the administered dose in the time interval from 0 to last quantifiable time point (fe urine,0-tz ) (time frame: Up to 22 days.). 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 20 Sep 2024.