HealthyPhase 1NCT02258971
Metabolism and Pharmacokinetics of [14C] BEA 2180 BR Administered Orally Compared to [14C] BEA 2180 BR Administered Intravenously in Healthy Male Volunteers
A Phase 1 study testing BEA 2180 BR oral and BEA 2180 BR infusion in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Primary objectives: To determine the basic pharmacokinetics of BEA 2180 BR, its metabolites CD 1975 ZW and CD 1976 ZW and radioactivity including excretion mass balance, excretion pathways and metabolism following the oral and intravenous administration of [14C] BEA 2180 BR Secondary objectives: To determine safety… Read more about this study
- Who is it for?
- Ages 35 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BEA 2180 BR oral and BEA 2180 BR 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
- 14 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to May 2007
- 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 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older 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 electrocardiogram (ECG), clinical laboratory tests
- Age ≥35 and Age ≤70 years
- BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
- 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
- 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 blood pressure (BP), pulse rate (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 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 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 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)more than 60 g/day).
- 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/Heart rate-corrected QT interval (QTc) interval (e.g., repeated demonstration of a QTc interval >450 ms)
- Veins unsuitable for infusion and blood sampling
- Pulse rate (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)
About this study
Official title: Investigation of the Metabolism and Pharmacokinetics of 1200 μg (Free Cation) [14C] BEA 2180 BR Administered Orally Compared to 500 μg (Free Cation) [14C] BEA 2180 BR Administered Intravenously in Healthy Male Volunteers in an Open Label, Single-dose and Parallel Study Design
Primary objectives: To determine the basic pharmacokinetics of BEA 2180 BR, its metabolites CD 1975 ZW and CD 1976 ZW and radioactivity including excretion mass balance, excretion pathways and metabolism following the oral and intravenous administration of [14C] BEA 2180 BR
Secondary objectives: To determine safety and tolerability following single dose oral and iv administration of BEA 2180 BR in healthy male volunteers.
- Conditions
- Healthy
- Being tested
- BEA 2180 BR oral, BEA 2180 BR infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEA 2180 BR oralDrug
Oral solution
BEA 2180 BR infusionDrug
Solution for infusion to be reconstituted with isotonic saline
| Study group | Role | What they receive |
|---|---|---|
| BEA 2180 BR oral | Experimental | Not described Receives: Drug: BEA 2180 BR oral |
| BEA 2180 BR infusion | Active comparator | Not described Receives: Drug: BEA 2180 BR infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual time course profiles of [14C] radioactivity
Measured: Up to 312 hours after drug administration
Individual time course profiles of BEA 2180 and its metabolites CD 1975 ZW and CD 1976 ZW
Measured: Up to 312 hours after drug administration
Rate and extent of excretion mass balance based on the total radioactivity in urine and faeces
Measured: Up to 312 hours after drug administration
Elucidation of metabolite structures and identification of major metabolites in plasma, urine, and faeces (if feasible) in comparison with various animal species
Measured: Up to 312 hours after drug administration
Cblood cells/Cplasma ratio of [14C] -radioactivity
Measured: Up to 96 hours after drug administration
Cmax (maximum concentration of the analyte(s) in plasma)
Measured: Up to 96 hours after drug administration
tmax (time from dosing to the maximum concentration of the analyte(s) in plasma)
Measured: Up to 96 hours 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: Up to 96 hours after drug administration
AUC0-∞ (area under the concentration-time curve of the analyte(s) in plasma over the time interval from 0 to infinity)
Measured: Up to 96 hours after drug administration
λz (terminal rate constant in plasma)
Measured: Up to 96 hours after drug administration
t1/2 (terminal half-life of the analyte(s) in plasma)
Measured: Up to 96 hours after drug administration
MRT (mean residence time of the analyte(s) in the body)
Measured: Up to 96 hours after drug administration
CL (total clearance of the analyte in plasma)
Measured: Up to 96 hours after drug administration
Vz (apparent volume of distribution during the terminal phase λz)
Measured: Up to 96 hours after drug administration
Vss (apparent volume of distribution at steady state)
Measured: Up to 96 hours after drug administration
fe0-tz (amount of analyte excreted in urine within the time interval zero to tz in % of dose)
Measured: Up to 312 hours after drug administration
fefaeces,0-tz (amount of analyte excreted in faeces within the time interval zero to tz in %) of dose, additionally excretion within each sampling interval will be calculated)
Measured: Up to 312 hours after drug administration
CLR,0-tz (renal clearance of analyte)
Measured: Up to 96 hours after drug administration
Fa (fraction of drug absorbed after oral administration based on radioactivity data) based on oral and i.v. data
Measured: Up to 96 hours after drug administration
Secondary outcomes (7)
Number of participants with abnormal findings in physical examination
Measured: Up to day 29 after first drug administration
Number of participants with clinically significant changes in vital signs
Measured: Up to day 29 after first drug administration
Number of participants with abnormal findings in 12-lead ECG
Measured: Up to day 29 after first drug administration
Number of participants with abnormal changes in clinical laboratory parameters
Measured: Up to day 29 after first drug administration
Number of participants with adverse events
Measured: Up to day 29 after first drug administration
Investigator global clinical assessment on a 4-point scale
Measured: Up to day 15 after first drug administration
Investigator assessed local tolerability on a 6-point scale
Measured: Up to day 15 after first drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startMar 2007
- Primary completionMay 2007
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
- 14 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
- NCT02258971
- Sponsor's protocol ID
- 1205.8
- Status last verified
- Sep 2014
- First submitted
- 1 Oct 2014
- Last updated
- 8 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Metabolism and Pharmacokinetics of 1200 μg (Free Cation) [14C] BEA 2180 BR Administered Orally Compared to 500 μg (Free Cation) [14C] BEA 2180 BR Administered Intravenously in Healthy Male Volunteers in an Open Label, Single-dose and Parallel Study Design
- ClinicalTrials.gov ID
- NCT02258971
- Acronym / sponsor ID
- 1205.8
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- May 2007 (actual)
- First posted
- 8 Oct 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 objectives: To determine the basic pharmacokinetics of BEA 2180 BR, its metabolites CD 1975 ZW and CD 1976 ZW and radioactivity including excretion mass balance, excretion pathways and metabolism following the oral and intravenous administration of [14C] BEA 2180 BR
Secondary objectives: To determine safety and tolerability following single dose oral and iv administration of BEA 2180 BR in healthy male volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BEA 2180 BR oral | Experimental | Drug: BEA 2180 BR oral |
| BEA 2180 BR infusion | Active comparator | Drug: BEA 2180 BR infusion |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy males according to the following criteria:
- Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead electrocardiogram (ECG), clinical laboratory tests
- Age ≥35 and Age ≤70 years
- BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
- 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
Key exclusion criteria (23 listed)
- Any finding of the medical examination (including blood pressure (BP), pulse rate (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 |
|---|---|---|
| BEA 2180 BR oralOral solution | Drug | BEA 2180 BR oral |
| BEA 2180 BR infusionSolution for infusion to be reconstituted with isotonic saline | Drug | BEA 2180 BR infusion |
Primary outcome
Individual time course profiles of [14C] radioactivity
Time frame: Up to 312 hours after drug administration
Individual time course profiles of BEA 2180 and its metabolites CD 1975 ZW and CD 1976 ZW
Time frame: Up to 312 hours after drug administration
Rate and extent of excretion mass balance based on the total radioactivity in urine and faeces
Time frame: Up to 312 hours after drug administration
Elucidation of metabolite structures and identification of major metabolites in plasma, urine, and faeces (if feasible) in comparison with various animal species
Time frame: Up to 312 hours after drug administration
Cblood cells/Cplasma ratio of [14C] -radioactivity
Time frame: Up to 96 hours after drug administration
Cmax (maximum concentration of the analyte(s) in plasma)
Time frame: Up to 96 hours after drug administration
tmax (time from dosing to the maximum concentration of the analyte(s) in plasma)
Time frame: Up to 96 hours 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: Up to 96 hours after drug administration
AUC0-∞ (area under the concentration-time curve of the analyte(s) in plasma over the time interval from 0 to infinity)
Time frame: Up to 96 hours after drug administration
λz (terminal rate constant in plasma)
Time frame: Up to 96 hours after drug administration
t1/2 (terminal half-life of the analyte(s) in plasma)
Time frame: Up to 96 hours after drug administration
MRT (mean residence time of the analyte(s) in the body)
Time frame: Up to 96 hours after drug administration
CL (total clearance of the analyte in plasma)
Time frame: Up to 96 hours after drug administration
Vz (apparent volume of distribution during the terminal phase λz)
Time frame: Up to 96 hours after drug administration
Vss (apparent volume of distribution at steady state)
Time frame: Up to 96 hours after drug administration
fe0-tz (amount of analyte excreted in urine within the time interval zero to tz in % of dose)
Time frame: Up to 312 hours after drug administration
fefaeces,0-tz (amount of analyte excreted in faeces within the time interval zero to tz in %) of dose, additionally excretion within each sampling interval will be calculated)
Time frame: Up to 312 hours after drug administration
CLR,0-tz (renal clearance of analyte)
Time frame: Up to 96 hours after drug administration
Fa (fraction of drug absorbed after oral administration based on radioactivity data) based on oral and i.v. data
Time frame: Up to 96 hours after drug administration
7 secondary outcomes
Number of participants with abnormal findings in physical examination
Time frame: Up to day 29 after first drug administration
Number of participants with clinically significant changes in vital signs
Time frame: Up to day 29 after first drug administration
Number of participants with abnormal findings in 12-lead ECG
Time frame: Up to day 29 after first drug administration
Number of participants with abnormal changes in clinical laboratory parameters
Time frame: Up to day 29 after first drug administration
Number of participants with adverse events
Time frame: Up to day 29 after first drug administration
Investigator global clinical assessment on a 4-point scale
Time frame: Up to day 15 after first drug administration
Investigator assessed local tolerability on a 6-point scale
Time frame: Up to day 15 after first 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 8 Oct 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 BEA 2180 BR oral and BEA 2180 BR 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 6 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 Oct 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 (time frame: Up to 312 hours after drug administration). The study lists 19 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 Oct 2014.