HealthyPhase 1NCT02172118

BI 1744 CL in Patients With Severe Renal Impairment in Comparison to Subjects With Normal Renal Function

A Phase 1 study testing BI 1774 CL in people with Healthy, run by Boehringer Ingelheim.

Completed

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

Trial summary

Study to assess the influence of severe renal impairment on the pharmacokinetics (PK), safety, and selected pharmacodynamic (PD) parameters of BI 1744 CL (30 μg administered by inhalation with the Respimat® Inhaler) Read more about this study

Who is it for?: Ages 21 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI 1774 CL
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: No sites listed yet
Study dates: Aug 2009to Dec 2009
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 21 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy subjects:
Healthy male and female subjects determined by results of screening with a creatinine clearance >80 mL/min (Treatment Group 2)
Age 21 - 75 years
Body Mass Index (BMI) >=18.5 and <=32 kg/m2
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
Renally impaired subjects:

Show all 10Show fewer

Renally impaired male or female subjects (Treatment Group 1) determined by results of screening with the following creatinine clearance as estimated according to Cockroft-Gault: Creatinine clearance <30 mL/min (Treatment Group 1, Renal Function Group 4)
Age 21 - 75 years
BMI >=18.5 and <=34 kg/m2
Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

Who cannot join

Healthy subjects who meet any of the following criteria will not be entered into this trial:
Any finding of the medical examination (including blood pressure (BP) [>140 mmHg systolic and or >95 mmHg diastolic], pulse rate (PR) and electrocardiogram (ECG)) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Relevant gastrointestinal tract surgery (except appendectomy, herniotomy)
Diseases of the central nervous system (such as epilepsy, seizures) or psychiatric disorders or neurological disorders

Show all 60Show fewer

History of relevant orthostatic hypotension, fainting spells or blackouts
Chronic or relevant acute infections (e.g. including Hepatitis B and C and HIV)
History of allergy/hypersensitivity (including drug allergies) that are deemed relevant to the trial as judged by the investigator
Intake of drugs with a long half-life (>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
Participation in another trial with an investigational drug within one month after previous single dose administration or two months after previous multiple dose administration prior to administration or during the trial
Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
Inability to refrain from smoking when confined to the study site on trial days
Alcohol abuse (more than 40 g/day in males, more than 20 g/day in females)
Drug abuse, in the investigator's judgement upon review of the patient's history and urine screening for abused substances
Veins unsuited for iv puncture on either arm (e.g. veins which are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture)
Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
Excessive physical activities (within 48 hours prior to trial or during the trial)
Any laboratory value outside the reference range that is of clinical relevance
Inability to comply with dietary regimen of study centre
Subjects not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
Renally impaired subjects who meet any of the following criteria will not be entered into this trial:
Moderate and severe concurrent liver function impairment (e.g. due to hepatorenal syndrome)
Patients with significant diseases other than renal impairment will be excluded. A significant disease is defined as a disease which in the opinion of the investigator
put the patient at risk because of participation in the study
may influence the results of the study
may influence the patient's ability to participate in the study
is not in a stable condition
Diabetic or hypertensive patients can be entered in this trial if the disease is not significant according to these criteria.
Relevant gastrointestinal tract surgery (except appendectomy, herniotomy)
Diseases of the central nervous system (such as epilepsy, seizures) or psychiatric disorders or neurological disorders
History of relevant orthostatic hypotension, fainting spells or blackouts
Chronic or relevant acute infections (e.g. including Hepatitis B and C and HIV)
History of allergy/hypersensitivity (including drug allergies) that are deemed relevant to the trial as judged by the investigator
Intake of drugs with a long half-life (>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial, excluded are those drugs, the patient is currently taking for treatment of the renal or concomitant disease
Subjects with a change of their chronic medication less than 4 weeks prior to dosing
Participation in another trial with an investigational drug within one month after previous single dose administration or two months after previous multiple dose administration prior to administration or during the trial
Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
Inability to refrain from smoking when confined to the study site on trial days
Alcohol abuse (more than 40 g/day in males, more than 20 g/day in females)
Drug abuse, in the investigator's judgement upon review of the patient's history and urine screening for abused substances
Veins unsuited for iv puncture on either arm (e.g. veins which are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture)
Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
Excessive physical activities (within 48 hours prior to trial or during the trial)
Clinically relevant laboratory abnormalities (except for renal function tests or deviations of clinical laboratory values that are related to renal impairment)
Hemoglobin < 8 g/dL indicating severe renal anemia (use of erythropoetin is allowed to maintain hematocrit)
Inability to comply with dietary regimen of study centre
Subjects not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
Systolic blood pressure < 100 or > 180 mm Hg, diastolic blood pressure < 60 or > 110 mm Hg, pulse rate < 50 or > 100 1/min
Exclusion criteria specific for this study due to the known class side effect profile of ß2- mimetics (healthy or renally impaired subjects):
Asthma or history of pulmonary hyperreactivity
Hyperthyrosis
Allergic rhinitis in need of treatment
Clinically relevant cardiac arrhythmia
For female subjects (healthy or renally impaired):
Pregnancy or planning to become pregnant within 2 months of study completion
Positive pregnancy test
No adequate contraception in women of childbearing potential (adequate contraception: e.g. sterilisation, intrauterine device or oral contraception not containing ethinyl estradiol or ethinyl estradiol with an additional barrier method) for at least 3 months prior to participation in the study
Inability to maintain this adequate contraception during the whole trial period
Lactation period

About this study

Official title: Pharmacokinetics, Safety and Tolerability of Single Dose of BI 1744 CL (30 μg Administered With the Respimat® Inhaler) in Patients With Severe Renal Impairment in Comparison to Subjects With Normal Renal Function in a Monocentric, Open Label, Parallel Group Phase I Trial

Conditions: Healthy
Being tested: BI 1774 CL

What participants receive

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

BI 1774 CLDrug

Study groups in NCT02172118
Study group	Role	What they receive
severely renally impaired patients	Experimental	Not described Receives: Drug: BI 1774 CL
healthy volunteers	Experimental	Not described Receives: Drug: BI 1774 CL

What is being measured

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

AUC0-4 (area under the concentration time curve of the analyte in plasma over the time interval from 0 to 4 hours after dosing)
Measured: before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration
Cmax (maximum concentration of the analyte in plasma)
Measured: before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration

Secondary outcomes (14)

tmax (time from dosing to the maximum concentration of the analyte in plasma)
Measured: before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration
AUC (area under the concentration-time curve of the analyte in plasma at different time points)
Measured: before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration
%AUCtz-∞ (percentage of area under the concentration-time curve obtained by extrapolation)
Measured: before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration
λz (terminal rate constant in plasma)
Measured: before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration
t1/2 (terminal half-life of the analyte in plasma)
Measured: before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration
MRTih (mean residence time of the analyte in the body after inhalation)
Measured: before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Measured: before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Measured: before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration
Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to t2)
Measured: before and at 0-8, 8-12, 12-24, 24-48, 48-72 hours following drug administration
fet1-t2 (fraction of analyte excreted in urine from the time point t1 to t2)
Measured: before and at 0-8, 8-12, 12-24, 24-48, 48-72 hours following drug administration
CLR,t1-t2 (renal clearance of the analyte in plasma from the time point t1 to t2)
Measured: before and at 0-8, 8-12, 12-24, 24-48, 48-72 hours following drug administration
Plasma protein binding of BI 1744 BS
Measured: before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration
Number of patients with adverse events
Measured: up to 5 weeks
Assessment of tolerability on a 4-point scale by the investigator
Measured: within 5 to 14 days after drug administration

Timeline

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

Aug 2009Dec 2009

First posted24 Jun 2014 (estimated)
Study startAug 2009
Primary completionDec 2009

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: Parallel groups
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02172118
Sponsor's protocol ID: 1222.35
Status last verified: Jun 2014
First submitted: 20 Jun 2014
Last updated: 24 Jun 2014
Results posted: No

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?

Official record

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics, Safety and Tolerability of Single Dose of BI 1744 CL (30 μg Administered With the Respimat® Inhaler) in Patients With Severe Renal Impairment in Comparison to Subjects With Normal Renal Function in a Monocentric, Open Label, Parallel Group Phase I Trial
ClinicalTrials.gov ID: NCT02172118
Acronym / sponsor ID: 1222.35
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Aug 2009
Primary completion: Dec 2009 (actual)
First posted: 24 Jun 2014 (estimated)
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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
severely renally impaired patients	Experimental	Drug: BI 1774 CL
healthy volunteers	Experimental	Drug: BI 1774 CL

Who may qualify

Ages: 21 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Healthy male and female subjects determined by results of screening with a creatinine clearance >80 mL/min (Treatment Group 2)
Age 21 - 75 years
Body Mass Index (BMI) >=18.5 and <=32 kg/m2
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
Renally impaired male or female subjects (Treatment Group 1) determined by results of screening with the following creatinine clearance as estimated according to Cockroft-Gault: Creatinine clearance <30 mL/min (Treatment Group 1, Renal Function Group 4)

Key exclusion criteria (60 listed)

Healthy subjects who meet any of the following criteria will not be entered into this trial:
Any finding of the medical examination (including blood pressure (BP) [>140 mmHg systolic and or >95 mmHg diastolic], pulse rate (PR) and electrocardiogram (ECG)) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Relevant gastrointestinal tract surgery (except appendectomy, herniotomy)

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 1774 CL	Drug	healthy volunteers, severely renally impaired patients

Primary outcome

AUC0-4 (area under the concentration time curve of the analyte in plasma over the time interval from 0 to 4 hours after dosing)
Time frame: before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration
Cmax (maximum concentration of the analyte in plasma)
Time frame: before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration

14 secondary outcomes

tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration
AUC (area under the concentration-time curve of the analyte in plasma at different time points)
Time frame: before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration
%AUCtz-∞ (percentage of area under the concentration-time curve obtained by extrapolation)
Time frame: before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration
λz (terminal rate constant in plasma)
Time frame: before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration
MRTih (mean residence time of the analyte in the body after inhalation)
Time frame: before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration
Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to t2)
Time frame: before and at 0-8, 8-12, 12-24, 24-48, 48-72 hours following drug administration
fet1-t2 (fraction of analyte excreted in urine from the time point t1 to t2)
Time frame: before and at 0-8, 8-12, 12-24, 24-48, 48-72 hours following drug administration
CLR,t1-t2 (renal clearance of the analyte in plasma from the time point t1 to t2)
Time frame: before and at 0-8, 8-12, 12-24, 24-48, 48-72 hours following drug administration
Plasma protein binding of BI 1744 BS
Time frame: before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration
Number of patients with adverse events
Time frame: up to 5 weeks
Assessment of tolerability on a 4-point scale by the investigator
Time frame: within 5 to 14 days after drug administration

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 24 Jun 2014.
Related InfoLink provided by the sponsor.

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 1774 CL in people with Healthy, run by Boehringer Ingelheim.

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 10 inclusion and 60 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 24 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

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?

AUC0-4 (area under the concentration time curve of the analyte in plasma over the time interval from 0 to 4 hours after dosing) (time frame: before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration). 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?

On the ClinicalTrials.gov record for NCT02172118.

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 24 Jun 2014.