Renal InsufficiencyPhase 1NCT03302091
A Study in People With Normal Kidney Function and People With Reduced Kidney Function to Test How BI 1467335 is Processed in the Body
A Phase 1 study testing BI 1467335 in people with Renal Insufficiency and Healthy, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
The primary objective of the current study is to investigate the influence of moderate renal impairment on the pharmacokinetics of multiple doses in comparison to a matched control group with normal renal function. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Insufficiency, Healthy
- What is being tested?
- BI 1467335
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 17 Oct 2017to 16 Aug 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Despite of moderate renal impairment (Group 1) healthy male or female subjects according to the assessment of the investigator, 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
- Estimated glomerular filtration rate (eGFR) based on CKD-EPI formula for Group 1 between 30 and 59 mL/min/1.73m2 and for Group 2 ≥ 90 mL/min/1.73m2
- Age of 18 to 79 years (incl.)
- BMI of 18.5 to 34 kg/m2 (incl.)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation
- Male subjects, or female subjects who meet any of the following criteria (according to the CTFG Recommendations related to contraception and pregnancy testing in clinical trials, methods with a failure rate of less than 1% per year) starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion, e.g.:
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- Use of adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives (inhibition of ovulation)
- Hormonal intrauterine device
- Sexually abstinent (defined as refraining from heterosexual intercourse during the entire period of risk)
- A vasectomised sexual partner (provided that vasectomy was performed at least 1 year prior to enrolment and the vasectomised partner has received medical assessment of the surgical success)
- Surgically sterilised (including bilateral tubal occlusion, hysterectomy)
- Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory)
Who cannot join
- Healthy subjects
- Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged 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 50 to 90 bpm
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease judged as clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
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- Estimated glomerular filtration rate (eGFR) calculated by CKD-EPI formula < 90 mL/min/1.73m2
- Subjects with moderate renal impairment
- Subject with significant diseases other than moderate renal impairment. A significant disease is defined as a disease which in the opinion of the investigator:
- puts the subjects at risk because of participation in the study
- may influence the results of the study
- may influence the subject's ability to participate in the study
- is not in a stable condition Diabetic or hypertensive subjects can be entered in this trial if the disease is not significant according to these criteria.
- Any finding of the medical examination (including BP, PR and ECG) of clinical relevance
- Moderate and severe concurrent liver function impairment (e.g. due to hepatorenal syndrome) or biliary obstruction
- Clinically relevant laboratory abnormalities (except for renal function tests or deviation of clinical laboratory values that are related to renal impairment)
- eGFR calculated by CKD-EPI formula ≥ 60 mL/min/1.73m2 and < 30 mL/min/1.73m2
- For all subjects
- Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and 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, fainting spells, or blackouts
- Chronic or relevant acute infections
- History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
- Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)
- Participation in another trial where an investigational drug has been administered within 30 days prior to planned administration of trial medication or longer if required by local regulation, or within 5-half-lives of the investigational agent taken (whichever is longer), or current participation in another trial involving administration of investigational drug
- Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
- Inability to refrain from smoking on specified trial days
- Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for males)
- Drug abuse or positive drug screening
- Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial
- Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial
- Inability to comply with dietary regimen of trial site
- A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females) or any other relevant ECG finding at screening
- A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)
- Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
- Female subjects will not be allowed to participate if any of the following applies:
- Positive pregnancy test, pregnancy or plans to become pregnant within 30 days after study completion
- Lactation period
- Male subjects will not be allowed to participate if any of the following applies:
- Male subjects with WOCBP partner who are unwilling to use male contraception (condom or sexual abstinence) from the first administration of trial medication until 30 days after last administration of trial medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics, Safety and Tolerability After Multiple Dose Administration of BI 1467335 in Subjects With Moderate Renal Impairment and Subjects With Normal Renal Function (a Mono-centric, Open-label Study in Matched-group Design)
The primary objective of the current study is to investigate the influence of moderate renal impairment on the pharmacokinetics of multiple doses in comparison to a matched control group with normal renal function.
- Conditions
- Renal Insufficiency, Healthy
- Being tested
- BI 1467335
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 1467335Drug
28 day treatment period
| Study group | Role | What they receive |
|---|---|---|
| BI 1467335 Normal (R) | Experimental | Participants with normal renal function. Receives: Drug: BI 1467335 |
| BI 1467335 Moderate (T) | Experimental | Participants with moderate renal impairment. Receives: Drug: BI 1467335 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Time Interval From 0 to 24 Hours After Administration of the First Dose (AUC0-24)
Area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of the first dose AUC 0-24.
Standard Error presented is actually geometric Standard Error. PKS-stat including participants data for AUC(0-24). The pharmacokinetic (PK) analysis set (PKS) included all subjects in the TS who provided at least one PK parameter that was defined as primary or secondary endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Measured: Pharmacokinetic (PK) samples were taken 2.00 hours (h) before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.
Maximum Measured Concentration of BI 1467335 in Plasma After Administration of the First Dose (Cmax)
Maximum measured concentration of BI 1467335 in plasma after administration of the first dose (Cmax).
Standard Error presented is actually geometric Standard Error.
Measured: Pharmacokinetic (PK) samples were taken 2.00 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.
Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 28th Dose (AUCτ,28)
Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 28th dose (AUCτ,28).
Standard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00".
Measured: Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28.
Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 28th Dose (Cmax,28)
Maximum measured concentration of BI 1467335 in plasma following administration of the 28th dose (Cmax,28).
Standard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00".
Measured: Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28.
Secondary outcomes (2)
Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 14th Dose (AUCτ,14)
Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 14th dose (AUCτ,14).
Standard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00".
Measured: Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14.
Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 14th Dose (Cmax,14)
Maximum measured concentration of BI 1467335 in plasma following administration of the 14th dose (Cmax,14).
Standard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00".
Measured: Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start17 Oct 2017
- Primary completion16 Aug 2018
- Study completion16 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Renal InsufficiencyStudies 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
- 20 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
- NCT03302091
- Sponsor's protocol ID
- 1386-0002
- Other IDs
- 2017-002180-18, 2017
- Status last verified
- May 2021
- First submitted
- 29 Sep 2017
- Last updated
- 4 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics, Safety and Tolerability After Multiple Dose Administration of BI 1467335 in Subjects With Moderate Renal Impairment and Subjects With Normal Renal Function (a Mono-centric, Open-label Study in Matched-group Design)
- ClinicalTrials.gov ID
- NCT03302091
- Acronym / sponsor ID
- 1386-0002
- Conditions
- Renal Insufficiency, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 16 Aug 2018 (actual)
- Study completion
- 16 Aug 2018 (actual)
- First posted
- 4 Oct 2017 (actual)
- Results
- Posted 4 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the current study is to investigate the influence of moderate renal impairment on the pharmacokinetics of multiple doses in comparison to a matched control group with normal renal function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 1467335 Normal (R) | Experimental | Drug: BI 1467335Participants with normal renal function. |
| BI 1467335 Moderate (T) | Experimental | Drug: BI 1467335Participants with moderate renal impairment. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Despite of moderate renal impairment (Group 1) healthy male or female subjects according to the assessment of the investigator, 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
- Estimated glomerular filtration rate (eGFR) based on CKD-EPI formula for Group 1 between 30 and 59 mL/min/1.73m2 and for Group 2 ≥ 90 mL/min/1.73m2
- Age of 18 to 79 years (incl.)
- BMI of 18.5 to 34 kg/m2 (incl.)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation
Key exclusion criteria (40 listed)
- Healthy subjects
- Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged 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 50 to 90 bpm
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease judged 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 146733528 day treatment period | Drug | BI 1467335 Moderate (T), BI 1467335 Normal (R) |
Primary outcome
Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Time Interval From 0 to 24 Hours After Administration of the First Dose (AUC0-24)
Time frame: Pharmacokinetic (PK) samples were taken 2.00 hours (h) before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.
Area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of the first dose AUC 0-24. Standard Error presented is actually geometric Standard Error. PKS-stat including participants data for AUC(0-24). The pharmacokinetic (PK) analysis set (PKS) included all subjects in the TS who provided at least one PK parameter that was defined as primary or secondary endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Maximum Measured Concentration of BI 1467335 in Plasma After Administration of the First Dose (Cmax)
Time frame: Pharmacokinetic (PK) samples were taken 2.00 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.
Maximum measured concentration of BI 1467335 in plasma after administration of the first dose (Cmax). Standard Error presented is actually geometric Standard Error.
Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 28th Dose (AUCτ,28)
Time frame: Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28.
Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 28th dose (AUCτ,28). Standard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00".
Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 28th Dose (Cmax,28)
Time frame: Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28.
Maximum measured concentration of BI 1467335 in plasma following administration of the 28th dose (Cmax,28). Standard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00".
2 secondary outcomes
Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 14th Dose (AUCτ,14)
Time frame: Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14.
Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 14th Dose (Cmax,14)
Time frame: Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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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 1467335 in people with Renal Insufficiency and 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 12 inclusion and 40 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 4 Jun 2021. 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?
Yes. Results are posted in the registry (first posted 4 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 BI 1467335 in Plasma Over the Time Interval From 0 to 24 Hours After Administration of the First Dose (AUC0-24) (time frame: Pharmacokinetic (PK) samples were taken 2.00 hours (h) before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.). 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 4 Jun 2021.