HealthyPhase 1NCT02183610
Investigation of the Metabolism and Pharmacokinetics of 10 mg [14C] BI 1356 Administered Orally Compared to 5 mg [14C] BI 1356 Administered Intravenously in Healthy Male Volunteers
A Phase 1 study testing [14C] BI 1356 as oral (p.o.) solution and [14C] BI 1356 solution for i.v. infusion in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To determine the basic pharmacokinetics of BI 1356 BS, its metabolite CD 1750 XX and radioactivity including excretion mass balance, excretion pathways and metabolism following the intravenous and oral administration of [14C] BI 1356 BS Read more about this study
- Who is it for?
- Ages 30 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- [14C] BI 1356 as oral (p.o.) solution and [14C] BI 1356 solution for i.v. infusion
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jul 2006to Sep 2006
- 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 30 to 60 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 Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), clinical laboratory tests
- Age >=30 and Age <=60 years
- BMI >=18.5 and BMI <=29.9 kg/m2 (Body Mass Index)
- 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 23Show fewer
- History of relevant allergy/hypersensitivity (including allergy to 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 or during the trial
- 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 60 g/day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within one week prior to administration 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
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms);
- Male subjects must agree to minimize the risk of female partners becoming pregnant from the dosing day until 3 months after the completion of the study. Acceptable methods of contraception for male volunteers include a vasectomy no less than 3 months prior to dosing, barrier contraception or a medically accepted contraceptive method. For female partners of male volunteers, acceptable methods of contraception include intra-uterine device, tubal ligation, hormonal contraceptive since at least two months and diaphragm with spermicide
- Veins unsuitable for infusion and blood sampling
- PR interval >220 ms or QRS interval >120 ms
- Female gender
About this study
Official title: Investigation of the Metabolism and Pharmacokinetics of 10 mg [14C] BI 1356 Administered Orally Compared to 5 mg [14C] BI 1356 Administered Intravenously in Healthy Male Volunteers in an Open Label, Single-dose and Parallel Study Design
To determine the basic pharmacokinetics of BI 1356 BS, its metabolite CD 1750 XX and radioactivity including excretion mass balance, excretion pathways and metabolism following the intravenous and oral administration of [14C] BI 1356 BS
- Conditions
- Healthy
- Being tested
- [14C] BI 1356 as oral (p.o.) solution, [14C] BI 1356 solution for i.v. infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C] BI 1356 as oral (p.o.) solutionDrug
[14C] BI 1356 solution for i.v. infusionDrug
| Study group | Role | What they receive |
|---|---|---|
| [14C] BI 1356 as oral (p.o.) solution | Experimental | Not described Receives: Drug: [14C] BI 1356 as oral (p.o.) solution |
| [14C] BI 1356 solution for i.v. infusion | Experimental | Not described Receives: Drug: [14C] BI 1356 solution for i.v. infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of individual time course profiles of [14C] radioactivity in whole blood, plasma, urine and faeces
Measured: before and up to 264 h after drug administration
Comparison of individual time course profiles of BI 1356 BS and its metabolite CD 1750 XX in plasma and urine
Measured: before and up to 264 h after drug administration
Rate and extent of excretion mass balance based on the total radioactivity in urine and faeces
Measured: prior to and up to 120 h after start of administration
CBlood cell/Cplasma ratio of [14C] -radioactivity
Measured: 1:30, 3, 24 and 72 h after drug administration
Measurement of the plasma protein binding of total [14C] radioactivity in human plasma samples ex vivo
Measured: 1:30 and 3 hours post drug administration
Cmax (maximum concentration of the analyte(s) in plasma)
Measured: before and up to 264 h after drug administration
tmax (time from dosing to the maximum concentration of the analyte(s) in plasma)
Measured: before and up to 264 h after drug administration
AUC0-tz (area under the concentration-time curve of the analyte(s) in plasma over the time interval from 0 to the time of the last quantifiable data point)
Measured: before and up to 264 h after drug administration
AUC0-infinity (area under the concentration-time curve of the analyte(s) in plasma over the time interval from 0 to infinity)
Measured: before and up to 264 h after drug administration
λz (terminal rate constant in plasma)
Measured: before and up to 264 h after drug administration
t1/2 (terminal half-life of the analyte(s) in plasma)
Measured: before and up to 264 h after drug administration
MRTpo and MRT, respectively (mean residence time of the analyte(s) in the body after p.o. and i.v. administration)
Measured: before and up to 264 h after drug administration
CL/F (apparent/total clearance of the analyte(s) in plasma following extravascular and intravenous administration)
Measured: before and up to 264 h after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular or intravenous administration (F=1) respectively)
Measured: before and up to 264 h after drug administration
feurine,0-tz (amount of analyte excreted in urine within the time interval zero to tz (=120 h) in % of dose)
Measured: prior to and up to 120 h after start of administration
fefaeces,0-tz (amount of analyte excreted in faeces within the time interval zero to tz (=120 h) in % of dose)
Measured: up to 120 h after drug administration
CLR,0-tz (renal clearance of analyte)
Measured: prior to and up to 120 h after start of administration
Fa (drug absorption based on radioactivity data)
Measured: up to 264 h after drug administration
Secondary outcomes (3)
Number of patients with adverse events
Measured: up to 47 days
Global assessment of tolerability by investigator on a 4-point scale
Measured: on day 12 during ambulant visit or on day of discharge on day 13, 14 or 15
Evaluation of local tolerability of the infusion by investigator on a 6-point scale
Measured: after start of infusion up to day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startJul 2006
- Primary completionSep 2006
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
- 12 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
- NCT02183610
- Sponsor's protocol ID
- 1218.7
- Status last verified
- Jul 2014
- First submitted
- 7 Jul 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Metabolism and Pharmacokinetics of 10 mg [14C] BI 1356 Administered Orally Compared to 5 mg [14C] BI 1356 Administered Intravenously in Healthy Male Volunteers in an Open Label, Single-dose and Parallel Study Design
- ClinicalTrials.gov ID
- NCT02183610
- Acronym / sponsor ID
- 1218.7
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Sep 2006 (actual)
- First posted
- 8 Jul 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.
To determine the basic pharmacokinetics of BI 1356 BS, its metabolite CD 1750 XX and radioactivity including excretion mass balance, excretion pathways and metabolism following the intravenous and oral administration of [14C] BI 1356 BS
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| [14C] BI 1356 as oral (p.o.) solution | Experimental | Drug: [14C] BI 1356 as oral (p.o.) solution |
| [14C] BI 1356 solution for i.v. infusion | Experimental | Drug: [14C] BI 1356 solution for i.v. infusion |
Who may qualify
- Ages
- 30 to 60 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 Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), clinical laboratory tests
- Age >=30 and Age <=60 years
- BMI >=18.5 and BMI <=29.9 kg/m2 (Body Mass Index)
- 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 (23 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 |
|---|---|---|
| [14C] BI 1356 as oral (p.o.) solution | Drug | [14C] BI 1356 as oral (p.o.) solution |
| [14C] BI 1356 solution for i.v. infusion | Drug | [14C] BI 1356 solution for i.v. infusion |
Primary outcome
Comparison of individual time course profiles of [14C] radioactivity in whole blood, plasma, urine and faeces
Time frame: before and up to 264 h after drug administration
Comparison of individual time course profiles of BI 1356 BS and its metabolite CD 1750 XX in plasma and urine
Time frame: before and up to 264 h after drug administration
Rate and extent of excretion mass balance based on the total radioactivity in urine and faeces
Time frame: prior to and up to 120 h after start of administration
CBlood cell/Cplasma ratio of [14C] -radioactivity
Time frame: 1:30, 3, 24 and 72 h after drug administration
Measurement of the plasma protein binding of total [14C] radioactivity in human plasma samples ex vivo
Time frame: 1:30 and 3 hours post drug administration
Cmax (maximum concentration of the analyte(s) in plasma)
Time frame: before and up to 264 h after drug administration
tmax (time from dosing to the maximum concentration of the analyte(s) in plasma)
Time frame: before and up to 264 h after drug administration
AUC0-tz (area under the concentration-time curve of the analyte(s) in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: before and up to 264 h after drug administration
AUC0-infinity (area under the concentration-time curve of the analyte(s) in plasma over the time interval from 0 to infinity)
Time frame: before and up to 264 h after drug administration
λz (terminal rate constant in plasma)
Time frame: before and up to 264 h after drug administration
t1/2 (terminal half-life of the analyte(s) in plasma)
Time frame: before and up to 264 h after drug administration
MRTpo and MRT, respectively (mean residence time of the analyte(s) in the body after p.o. and i.v. administration)
Time frame: before and up to 264 h after drug administration
CL/F (apparent/total clearance of the analyte(s) in plasma following extravascular and intravenous administration)
Time frame: before and up to 264 h after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular or intravenous administration (F=1) respectively)
Time frame: before and up to 264 h after drug administration
feurine,0-tz (amount of analyte excreted in urine within the time interval zero to tz (=120 h) in % of dose)
Time frame: prior to and up to 120 h after start of administration
fefaeces,0-tz (amount of analyte excreted in faeces within the time interval zero to tz (=120 h) in % of dose)
Time frame: up to 120 h after drug administration
CLR,0-tz (renal clearance of analyte)
Time frame: prior to and up to 120 h after start of administration
Fa (drug absorption based on radioactivity data)
Time frame: up to 264 h after drug administration
3 secondary outcomes
Number of patients with adverse events
Time frame: up to 47 days
Global assessment of tolerability by investigator on a 4-point scale
Time frame: on day 12 during ambulant visit or on day of discharge on day 13, 14 or 15
Evaluation of local tolerability of the infusion by investigator on a 6-point scale
Time frame: after start of infusion up to day 15
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 8 Jul 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 [14C] BI 1356 as oral (p.o.) solution and [14C] BI 1356 solution for i.v. infusion 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 23 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 8 Jul 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?
Comparison of individual time course profiles of [14C] radioactivity in whole blood, plasma, urine and faeces (time frame: before and up to 264 h after drug administration). The study lists 18 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 8 Jul 2014.