HealthyPhase 1NCT02171689
Metabolism and Pharmacokinetics of [14C]- BIBW 2992 MA2 in Healthy Male Volunteers
A Phase 1 study testing [14C]- BIBW 2992 MA2 in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The aim of the study was to investigate the metabolism and pharmacokinetics of BIBW 2992 MA2 after a single oral dose of [14C]-radiolabelled BIBW 2992 MA2 in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 35 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- [14C]- BIBW 2992 MA2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Jul 2006to Aug 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 35 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects as determined by results of screening
- Signed written informed consent in accordance with Good Clinical Practice and local legislation
- Age ≥35 and ≤60 years
- Body Mass Index ≥18.5 kg/m2 and ≤29.9 kg/m2
Who cannot join
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
- History of any major surgery within the last four weeks before participation in this study or any bone fracture within the last two months
- History of orthostatic hypotension, fainting spells and blackouts
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
- Chronic or relevant acute infections
Show all 17Show fewer
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Intake of drugs with a long half-life (> 24 hours) within 1 month prior to administration
- Planned use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within 2 months prior to administration or during trial
- Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
- Alcohol abuse (> 60 g/day)
- Drug abuse
- Blood donation within 1 month prior to administration or during the trial
- Excessive physical activities within 5 days prior to administration or during the trial
- Any laboratory value outside the reference range, unless considered to lack clinical reference
- 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
About this study
Official title: Metabolism and Pharmacokinetics of [14C]- BIBW 2992 MA2 After Administration of Single Doses of 15 mg [14C]- BIBW 2992 MA2 Oral Solution in Healthy Male Volunteers
The aim of the study was to investigate the metabolism and pharmacokinetics of BIBW 2992 MA2 after a single oral dose of [14C]-radiolabelled BIBW 2992 MA2 in healthy male volunteers. Metabolites in human plasma and excretions were measured, the structures of the metabolites analysed and compared with metabolites in animals. In addition, the mass-balance of excretion, the protein binding of [14C]-radioactivity, the plasma concentrations of BIBW 2992 MA2, and the [14C]-radioactivity in blood cells, plasma, urine and faeces were measured. The safety and tolerability of BIBW 2992 were also investigated.
- Conditions
- Healthy
- Being tested
- [14C]- BIBW 2992 MA2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]- BIBW 2992 MA2Drug
| Study group | Role | What they receive |
|---|---|---|
| BIBW 2992 MA2 | Experimental | Not described Receives: Drug: [14C]- BIBW 2992 MA2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
[14C]-radioactivity in plasma and whole blood (CBlood cells/Cplasma ratio of [14C]-radioactivity)
Measured: up to 96 hours after drug administration
[14C]-radioactivity in urine and faeces (excretion mass balance)
Measured: up to 120 hours after drug administration
Measurement of the plasma protein binding of total [14C]-radioactivity
Measured: up to 96 hours after drug administration
Concentrations of the analyte in plasma, urine, and faeces
Measured: up to 96 hours after drug administration
Cmax (maximum observed concentration of the analyte in plasma)
Measured: up to 96 hours after drug administration
tmax (time from dosing to peak concentration (Cmax))
Measured: up to 96 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Measured: up to 96 hours after drug administration
λz (terminal rate constant of the analyte in plasma)
Measured: up to 96 hours after drug administration
AUC (area under the concentration-time curve of the analyte in plasma) for different time points
Measured: up to 96 hours after drug administration
MRTpo (mean residence time of the analyte molecules in the body after oral administration)
Measured: up to 96 hours after drug administration
CL/F (total clearance of the analyte in plasma following extravascular administration)
Measured: up to 96 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase following extravascular administration)
Measured: up to 96 hours after drug administration
fe0-tz (fraction of analyte eliminated in urine or faeces from 0 to the limit of the last quantifiable data point)
Measured: up to 120 hours after drug administration
Aet0-tz (amount of analyte eliminated in urine or faeces from 0 the limit of the last quantifiable data point)
Measured: up to 120 hours after drug administration
Plasma concentration time profiles of the analyte
Measured: up to 96 hours after drug administration
Plasma concentration-time profiles of total radioactivity in whole blood and plasma
Measured: up to 96 hours after drug administration
[14C]-metabolic profile and identification of metabolites in urine, faeces, blood cells and plasma
Measured: up to 120 hours after drug administration
Secondary outcomes (5)
Number of patients with clinically relevant changes in vital signs (Pulse rate (PR), systolic and diastolic blood pressure (BP))
Measured: Baseline, day 2, within 14 days after study drug administration
Number of patients with clinically relevant changes in ECG (electrocardiogram)
Measured: Baseline, day 2, within 14 days after study drug administration
Number of patients with clinically relevant changes in laboratory parameters
Measured: Baseline, day 2, within 14 days after study drug administration
Number of patients with adverse events
Measured: up to 27 days
Assessment of tolerability on a 4-point scale
Measured: within 14 days after study drug administration
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 startJul 2006
- Primary completionAug 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 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
- NCT02171689
- Sponsor's protocol ID
- 1200.25
- 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
- Metabolism and Pharmacokinetics of [14C]- BIBW 2992 MA2 After Administration of Single Doses of 15 mg [14C]- BIBW 2992 MA2 Oral Solution in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02171689
- Acronym / sponsor ID
- 1200.25
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Aug 2006 (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.
The aim of the study was to investigate the metabolism and pharmacokinetics of BIBW 2992 MA2 after a single oral dose of [14C]-radiolabelled BIBW 2992 MA2 in healthy male volunteers. Metabolites in human plasma and excretions were measured, the structures of the metabolites analysed and compared with metabolites in animals. In addition, the mass-balance of excretion, the protein binding of [14C]-radioactivity, the plasma concentrations of BIBW 2992 MA2, and the [14C]-radioactivity in blood cells, plasma, urine and faeces were measured. The safety and tolerability of BIBW 2992 were also investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIBW 2992 MA2 | Experimental | Drug: [14C]- BIBW 2992 MA2 |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects as determined by results of screening
- Signed written informed consent in accordance with Good Clinical Practice and local legislation
- Age ≥35 and ≤60 years
- Body Mass Index ≥18.5 kg/m2 and ≤29.9 kg/m2
Key exclusion criteria (17 listed)
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
- History of any major surgery within the last four weeks before participation in this study or any bone fracture within the last two months
- History of orthostatic hypotension, fainting spells and blackouts
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
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]- BIBW 2992 MA2 | Drug | BIBW 2992 MA2 |
Primary outcome
[14C]-radioactivity in plasma and whole blood (CBlood cells/Cplasma ratio of [14C]-radioactivity)
Time frame: up to 96 hours after drug administration
[14C]-radioactivity in urine and faeces (excretion mass balance)
Time frame: up to 120 hours after drug administration
Measurement of the plasma protein binding of total [14C]-radioactivity
Time frame: up to 96 hours after drug administration
Concentrations of the analyte in plasma, urine, and faeces
Time frame: up to 96 hours after drug administration
Cmax (maximum observed concentration of the analyte in plasma)
Time frame: up to 96 hours after drug administration
tmax (time from dosing to peak concentration (Cmax))
Time frame: up to 96 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 96 hours after drug administration
λz (terminal rate constant of the analyte in plasma)
Time frame: up to 96 hours after drug administration
AUC (area under the concentration-time curve of the analyte in plasma) for different time points
Time frame: up to 96 hours after drug administration
MRTpo (mean residence time of the analyte molecules in the body after oral administration)
Time frame: up to 96 hours after drug administration
CL/F (total clearance of the analyte in plasma following extravascular administration)
Time frame: up to 96 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase following extravascular administration)
Time frame: up to 96 hours after drug administration
fe0-tz (fraction of analyte eliminated in urine or faeces from 0 to the limit of the last quantifiable data point)
Time frame: up to 120 hours after drug administration
Aet0-tz (amount of analyte eliminated in urine or faeces from 0 the limit of the last quantifiable data point)
Time frame: up to 120 hours after drug administration
Plasma concentration time profiles of the analyte
Time frame: up to 96 hours after drug administration
Plasma concentration-time profiles of total radioactivity in whole blood and plasma
Time frame: up to 96 hours after drug administration
[14C]-metabolic profile and identification of metabolites in urine, faeces, blood cells and plasma
Time frame: up to 120 hours after drug administration
5 secondary outcomes
Number of patients with clinically relevant changes in vital signs (Pulse rate (PR), systolic and diastolic blood pressure (BP))
Time frame: Baseline, day 2, within 14 days after study drug administration
Number of patients with clinically relevant changes in ECG (electrocardiogram)
Time frame: Baseline, day 2, within 14 days after study drug administration
Number of patients with clinically relevant changes in laboratory parameters
Time frame: Baseline, day 2, within 14 days after study drug administration
Number of patients with adverse events
Time frame: up to 27 days
Assessment of tolerability on a 4-point scale
Time frame: within 14 days after study 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.
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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]- BIBW 2992 MA2 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 17 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?
[14C]-radioactivity in plasma and whole blood (CBlood cells/Cplasma ratio of [14C]-radioactivity) (time frame: up to 96 hours after drug administration). The study lists 17 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.