Liver DiseasesPhase 1NCT05731908
A Study to Test How BI 690517 is Taken up in the Body of People With and Without Liver Problems
A Phase 1 study testing BI 690517 in people with Liver Diseases and Healthy, run by Boehringer Ingelheim at 2 sites in United States.
Trial summary
The main objective of this trial is to assess the effect of mild and moderate hepatic impairment (Child-Pugh classification A and B) on the pharmacokinetics, safety, and tolerability of BI 690517 in comparison with a control group with normal hepatic function. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liver Diseases, Healthy
- What is being tested?
- BI 690517
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Feb 2023to 13 Apr 2023
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects aged at least 18 years at screening
- Body mass index of 18.5 to 36.0 kg/m2 (inclusive)
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- Women of childbearing potential1 and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.
- Inclusion criteria applying only to participants with impaired hepatic function:
- Hepatic impairment classified as Child-Pugh A (score 5-6 points) or Child-Pugh B (score 7-9 points)
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- Absence of clinically significant abnormalities, as based on a complete medical history including a full physical examination, vital signs (Blood pressure, Pulse rate), 12-lead Electric Cardiogram, and clinical laboratory tests at both screening and admission to trial site, with the exception of findings that in the opinion of the investigator are consistent with the participant's hepatic impairment.
- Medication and/or treatment regimens must have been stable (i.e., no dose adjustments) for at least 4 weeks prior to the screening period and should be kept stable until study completion. Fluctuating treatment regimens may be considered for inclusion on a case-by-case basis if the underlying disease is under control in the opinion of the investigator and must be agreed to by both the investigator and the sponsor's medical monitor.
- Inclusion criteria applying only to healthy participants with normal hepatic function:
- Healthy subjects according to the following criteria: the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests.
- Individually matched to participants with hepatic impairment according to sex, age, and weight
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 measurements of blood pressure and pulse rate out of range considered clinically significant by the investigator
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, except for laboratory values outside the reference range due to underlying disease
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator
- Surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except cholecystectomy, 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
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- History of relevant orthostatic hypotension, fainting spells, or blackouts
- Relevant chronic or acute infections
- Further exclusion criteria apply
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Omega Research Orlando, LLC
Orlando, Florida, 32808
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: Pharmacokinetics, Safety, and Tolerability of BI 690517 in Subjects With Mild and Moderate Liver Impairment (Child-Pugh Classification A and B) as Compared to Healthy Subjects
The main objective of this trial is to assess the effect of mild and moderate hepatic impairment (Child-Pugh classification A and B) on the pharmacokinetics, safety, and tolerability of BI 690517 in comparison with a control group with normal hepatic function.
- Conditions
- Liver Diseases, Healthy
- Being tested
- BI 690517
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 690517Drug
Also called Vicadrostat
BI 690517
| Study group | Role | What they receive |
|---|---|---|
| BI 690517 mild hepatic impairment (Child-Pugh A) | Experimental | Not described Receives: Drug: BI 690517 |
| BI 690517 normal hepatic function | Experimental | control group Receives: Drug: BI 690517 |
| BI 690517 moderate hepatic impairment (Child-Pugh B) | Experimental | Not described Receives: Drug: BI 690517 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Measured: Up to 4 days
Maximum measured concentration of the analyte in plasma (Cmax)
Measured: Up to 4 days
Secondary outcomes (1)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Measured: Up to 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start21 Feb 2023
- Primary completion13 Apr 2023
- Study completion13 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA global CRO
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731908
- Sponsor's protocol ID
- 1378-0016
- Status last verified
- Sep 2024
- First submitted
- 8 Feb 2023
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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
- Pharmacokinetics, Safety, and Tolerability of BI 690517 in Subjects With Mild and Moderate Liver Impairment (Child-Pugh Classification A and B) as Compared to Healthy Subjects
- ClinicalTrials.gov ID
- NCT05731908
- Acronym / sponsor ID
- 1378-0016
- Conditions
- Liver Diseases, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA global CRO
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 13 Apr 2023 (actual)
- Study completion
- 13 Apr 2023 (actual)
- First posted
- 16 Feb 2023 (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 objective of this trial is to assess the effect of mild and moderate hepatic impairment (Child-Pugh classification A and B) on the pharmacokinetics, safety, and tolerability of BI 690517 in comparison with a control group with normal hepatic function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BI 690517 mild hepatic impairment (Child-Pugh A) | Experimental | Drug: BI 690517 |
| BI 690517 normal hepatic function | Experimental | Drug: BI 690517control group |
| BI 690517 moderate hepatic impairment (Child-Pugh B) | Experimental | Drug: BI 690517 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female subjects aged at least 18 years at screening
- Body mass index of 18.5 to 36.0 kg/m2 (inclusive)
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- Women of childbearing potential1 and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.
- Hepatic impairment classified as Child-Pugh A (score 5-6 points) or Child-Pugh B (score 7-9 points)
Key exclusion criteria (9 listed)
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
- Repeated measurements of blood pressure and pulse rate out of range considered clinically significant by the investigator
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, except for laboratory values outside the reference range due to underlying disease
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator
- Surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except cholecystectomy, appendectomy or simple hernia repair)
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 690517Also: VicadrostatBI 690517 | Drug | BI 690517 mild hepatic impairment (Child-Pugh A), BI 690517 moderate hepatic impairment (Child-Pugh B), BI 690517 normal hepatic function |
Primary outcome
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: Up to 4 days
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: Up to 4 days
1 secondary outcome
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Time frame: Up to 4 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.
2 sites 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 in people with Liver Diseases and Healthy, run by Boehringer Ingelheim at 2 sites in United States.
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 11 inclusion and 9 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 2 sites in United States. 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?
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) (time frame: Up to 4 days). The study lists 2 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.