HealthyPhase 1NCT02172157
Investigation of the Metabolism and Pharmacokinetics of [14C]BI 1744 CL and [14C]BI 1744 CL Administered as an Oral Solution in Healthy Male Subjects
A Phase 1 study testing BI 1744 CL i.v. and BI 1744 CL oral in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Primary objective: To determine the basic pharmacokinetics of BI 1744 BS, its metabolite BI 1744 BS - glucuronide and [14C]-radioactivity including excretion mass balance, excretion pathways and metabolism following intravenous and oral administration of [14C]BI 1744 CL Secondary objective: To determine safety and… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 1744 CL i.v. and BI 1744 CL oral
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to Apr 2008
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
- Age ≥18 and ≤45 years
- Body mass index (BMI) ≥18.0 and BMI ≤30.0 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
Who cannot join
- Any finding of the medical examination (including BP, PR and 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
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic, or relevant acute infections
Show all 29Show fewer
- History of relevant allergy/hypersensitivity (including allergy to study drug or its excipients)
- 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
- Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration until after the last sample from Visit 2 is collected
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- Inability to refrain from smoking during the stay in the trial centre
- Alcohol abuse (more than on average 2 units of alcoholic beverages per day or more than 14 units per week (1 unit equals 1 pint [285 mL] of beer or lager, 1 glass [125 mL] of wine, 25 mL shot of 40% spirit))
- Drug abuse
- Blood donation (more than 100 mL within 60 days prior to study drug administration or during the trial)
- Excessive physical activities (within one week prior to administration or during the trial until follow-up examination)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of study centre
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
- Veins unsuitable for infusion and blood sampling
- PR interval >220 ms or QRS interval >120 ms
- Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton (excluding spinal column)), during work or during participation in a medical trial in the previous year
- Irregular defecation pattern (less than once per 2 days)
- The following exclusion criteria are specific for this study due to the known class side effect profile of β2-mimetics:
- Asthma or history of pulmonary hyperreactivity
- Hyperthyrosis
- Allergic rhinitis in need of treatment
- Clinically relevant cardiac arrhythmia
- Paroxysmal tachycardia (>100 beats per minute)
About this study
Official title: Investigation of the Metabolism and Pharmacokinetics of 20 μg (Calculated as Free Base) [14C]BI 1744 CL Administered as a 3-hour Infusion and 40 μg (Calculated as Free Base) [14C]BI 1744 CL Administered as an Oral Solution.
Primary objective:
To determine the basic pharmacokinetics of BI 1744 BS, its metabolite BI 1744 BS - glucuronide and [14C]-radioactivity including excretion mass balance, excretion pathways and metabolism following intravenous and oral administration of [14C]BI 1744 CL
Secondary objective:
To determine safety and tolerability following intravenous and oral administration of [14C]BI 1744 CL in healthy male subjects
- Conditions
- Healthy
- Being tested
- BI 1744 CL i.v., BI 1744 CL oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 1744 CL i.v.Drug
BI 1744 CL oralDrug
| Study group | Role | What they receive |
|---|---|---|
| BI 1744 CL i.v. (intravenous) infusion | Experimental | Not described Receives: Drug: BI 1744 CL i.v. |
| BI 1744 CL Oral solution | Active comparator | Not described Receives: Drug: BI 1744 CL oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual time course profiles of [14C]-radioactivity in whole blood, plasma, urine and faeces
Measured: Pre-dose and up to 216 hours after start of drug administration
Individual time course profiles of of the analyte in plasma and urine
Measured: Pre-dose and up to 216 hours after start of drug administration
Rate and extent of excretion mass balance based on the total radioactivity in urine and faeces
Measured: Pre-dose and up to 216 hours after start of drug administration
C (concentration) blood cells/C plasma ratio of [14C] -radioactivity
Measured: Pre-dose and up to 96 hours after start of drug administration
Plasma and urinary concentrations of the analyte
Measured: Pre-dose and up to 216 hours after start of drug administration
Whole blood, plasma and urinary concentrations of the [14C]-radioactivity
Measured: Pre-dose and up to 216 hours after start of drug administration
Cmax (maximum concentration of the analyte(s) in plasma)
Measured: Up to 96 hours after start of drug administration
tmax (time from dosing to the maximum concentration of the analyte(s) in plasma)
Measured: Up to 96 hours after start of drug administration
AUC (area under the concentration-time curve at different time points)
Measured: Up to 96 hours after start of drug administration
λz (terminal rate constant in plasma)
Measured: Up to 96 hours after start of drug administration
t1/2 (terminal half-life of the analyte(s) in plasma)
Measured: Up to 96 hours after start of drug administration
MRTpo and MRT, respectively (mean residence time of the analyte(s) in the body after po and iv administration)
Measured: Up to 96 hours after start of drug administration
CL and CL/F (total clearance of the analyte in plasma after iv and oral administration)
Measured: Up to 96 hours after start of drug administration
Vz and Vz/F (apparent volume of distribution during the terminal phase λz following an iv and oral dose)
Measured: Up to 96 hours after start of drug administration
Vss (apparent volume of distribution at steady state following intravascular administration)
Measured: Up to 96 hours after start of drug administration
Ae0-tz (amount of analyte that is eliminated in urine within the time interval zero to tz)
Measured: Up to 216 hours after start of drug administration
fe0-tz (fraction of analyte excreted in urine within the time interval zero to tz in % of dose)
Measured: Up to 216 hours after start of drug administration
Aefaeces,0-tz (amount of analyte excreted in faeces within the time interval zero to tz)
Measured: Up to 216 hours after start of drug administration
fefaeces,0-tz (fraction of analyte excreted in faeces within the time interval zero to tz in % of dose)
Measured: Up to 216 hours after start of drug administration
CLR,t1-t2 (renal clearance of analyte from the within the time interval t1 to t2)
Measured: Up to 216 hours after start of drug administration
Fa (fraction of drug absorbed after oral administration) based on total radioactivity data after oral and iv administrations
Measured: Up to 216 hours after start of drug administartion
F (oral bioavailability) based on parent BI 1744 CL concentration data after oral and iv administration
Measured: Up to 216 hours after start of drug administartion
Secondary outcomes (8)
Number of patients with clinical significant changes in vital signs
Measured: Baseline and up to 24 days after drug administration
Number of patients with abnormal findings in physical examination
Measured: Baseline and up to 24 days after drug administration
Number of patients with clinical significant changes in 12-lead ECG (electrocardiogram)
Measured: Baseline and up to 24 days after drug administration
Number of patients with changes in Telemetry (iv treatment only)
Measured: -0.5 and up to 24 h after iv drug administration
Number of patients with abnormal changes in laboratory parameters
Measured: Baseline and up to 24 days after drug administration
Number of patients with changes in Bedside potassium monitoring (iv treatment only)
Measured: Pre dose and up to 3.5 hours after drug administration
Number of patients with adverse events
Measured: Up to 24 days after drug administration
Assessment of tolerability (global tolerability (both treatments) and local tolerability (iv treatment only)) on a 4 point scale
Measured: At discharge on day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startFeb 2008
- Primary completionApr 2008
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
- 11 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
- NCT02172157
- Sponsor's protocol ID
- 1222.9
- Status last verified
- Jun 2014
- First submitted
- 20 Jun 2014
- Last updated
- 24 Jun 2014
- Results posted
- No
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
- Investigation of the Metabolism and Pharmacokinetics of 20 μg (Calculated as Free Base) [14C]BI 1744 CL Administered as a 3-hour Infusion and 40 μg (Calculated as Free Base) [14C]BI 1744 CL Administered as an Oral Solution.
- ClinicalTrials.gov ID
- NCT02172157
- Acronym / sponsor ID
- 1222.9
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Apr 2008 (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.
Primary objective:
To determine the basic pharmacokinetics of BI 1744 BS, its metabolite BI 1744 BS - glucuronide and [14C]-radioactivity including excretion mass balance, excretion pathways and metabolism following intravenous and oral administration of [14C]BI 1744 CL
Secondary objective:
To determine safety and tolerability following intravenous and oral administration of [14C]BI 1744 CL in healthy male subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 1744 CL i.v. (intravenous) infusion | Experimental | Drug: BI 1744 CL i.v. |
| BI 1744 CL Oral solution | Active comparator | Drug: BI 1744 CL oral |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
- Age ≥18 and ≤45 years
- Body mass index (BMI) ≥18.0 and BMI ≤30.0 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
Key exclusion criteria (29 listed)
- Any finding of the medical examination (including BP, PR and 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
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
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 1744 CL i.v. | Drug | BI 1744 CL i.v. (intravenous) infusion |
| BI 1744 CL oral | Drug | BI 1744 CL Oral solution |
Primary outcome
Individual time course profiles of [14C]-radioactivity in whole blood, plasma, urine and faeces
Time frame: Pre-dose and up to 216 hours after start of drug administration
Individual time course profiles of of the analyte in plasma and urine
Time frame: Pre-dose and up to 216 hours after start of drug administration
Rate and extent of excretion mass balance based on the total radioactivity in urine and faeces
Time frame: Pre-dose and up to 216 hours after start of drug administration
C (concentration) blood cells/C plasma ratio of [14C] -radioactivity
Time frame: Pre-dose and up to 96 hours after start of drug administration
Plasma and urinary concentrations of the analyte
Time frame: Pre-dose and up to 216 hours after start of drug administration
Whole blood, plasma and urinary concentrations of the [14C]-radioactivity
Time frame: Pre-dose and up to 216 hours after start of drug administration
Cmax (maximum concentration of the analyte(s) in plasma)
Time frame: Up to 96 hours after start of drug administration
tmax (time from dosing to the maximum concentration of the analyte(s) in plasma)
Time frame: Up to 96 hours after start of drug administration
AUC (area under the concentration-time curve at different time points)
Time frame: Up to 96 hours after start of drug administration
λz (terminal rate constant in plasma)
Time frame: Up to 96 hours after start of drug administration
t1/2 (terminal half-life of the analyte(s) in plasma)
Time frame: Up to 96 hours after start of drug administration
MRTpo and MRT, respectively (mean residence time of the analyte(s) in the body after po and iv administration)
Time frame: Up to 96 hours after start of drug administration
CL and CL/F (total clearance of the analyte in plasma after iv and oral administration)
Time frame: Up to 96 hours after start of drug administration
Vz and Vz/F (apparent volume of distribution during the terminal phase λz following an iv and oral dose)
Time frame: Up to 96 hours after start of drug administration
Vss (apparent volume of distribution at steady state following intravascular administration)
Time frame: Up to 96 hours after start of drug administration
Ae0-tz (amount of analyte that is eliminated in urine within the time interval zero to tz)
Time frame: Up to 216 hours after start of drug administration
fe0-tz (fraction of analyte excreted in urine within the time interval zero to tz in % of dose)
Time frame: Up to 216 hours after start of drug administration
Aefaeces,0-tz (amount of analyte excreted in faeces within the time interval zero to tz)
Time frame: Up to 216 hours after start of drug administration
fefaeces,0-tz (fraction of analyte excreted in faeces within the time interval zero to tz in % of dose)
Time frame: Up to 216 hours after start of drug administration
CLR,t1-t2 (renal clearance of analyte from the within the time interval t1 to t2)
Time frame: Up to 216 hours after start of drug administration
Fa (fraction of drug absorbed after oral administration) based on total radioactivity data after oral and iv administrations
Time frame: Up to 216 hours after start of drug administartion
F (oral bioavailability) based on parent BI 1744 CL concentration data after oral and iv administration
Time frame: Up to 216 hours after start of drug administartion
8 secondary outcomes
Number of patients with clinical significant changes in vital signs
Time frame: Baseline and up to 24 days after drug administration
Number of patients with abnormal findings in physical examination
Time frame: Baseline and up to 24 days after drug administration
Number of patients with clinical significant changes in 12-lead ECG (electrocardiogram)
Time frame: Baseline and up to 24 days after drug administration
Number of patients with changes in Telemetry (iv treatment only)
Time frame: -0.5 and up to 24 h after iv drug administration
Number of patients with abnormal changes in laboratory parameters
Time frame: Baseline and up to 24 days after drug administration
Number of patients with changes in Bedside potassium monitoring (iv treatment only)
Time frame: Pre dose and up to 3.5 hours after drug administration
Number of patients with adverse events
Time frame: Up to 24 days after drug administration
Assessment of tolerability (global tolerability (both treatments) and local tolerability (iv treatment only)) on a 4 point scale
Time frame: At discharge on day 10
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.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 1744 CL i.v. and BI 1744 CL oral 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 4 inclusion and 29 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?
Individual time course profiles of [14C]-radioactivity in whole blood, plasma, urine and faeces (time frame: Pre-dose and up to 216 hours after start of drug administration). The study lists 22 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 24 Jun 2014.