HealthyPhase 1NCT02215772
Metabolism and Pharmacokinetics of [14C]-BI 44370 BS Administered as an Oral Solution in Healthy Male Volunteers
A Phase 1 study testing BI 44370 BS in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to investigate the basic pharmacokinetics of BI 44370 BS, its metabolite CD 10419 BS, and 14C-radioactivity including mass balance, excretion pathways, and metabolism following a single oral administration of 200 mg [14C]BI 44370 BS to healthy male volunteers and to evaluate safety and tolerability following a… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 44370 BS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Oct 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 65 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 (blood pressure (BP), pulse rate (PR)), 12-lead ECG, clinical laboratory tests
- Age ≥18 and ≤65 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 24Show 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 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)
- Not willing to use adequate contraception (condoms use plus another form of contraception e.g. spermicide, oral contraceptive taken by female partner, sterilisation, intrauterine device) during the whole study period from the time of the first intake of study drug until three months after the last intake
About this study
Official title: A Phase I Trial to Investigate the Metabolism and Pharmacokinetics of an Open Label Single Dose of 200 mg [14C]-BI 44370 BS Administered as an Oral Solution in Healthy Male Volunteers
Study to investigate the basic pharmacokinetics of BI 44370 BS, its metabolite CD 10419 BS, and 14C-radioactivity including mass balance, excretion pathways, and metabolism following a single oral administration of 200 mg [14C]BI 44370 BS to healthy male volunteers and to evaluate safety and tolerability following a single oral administration of 200 mg [14C]BI 44370 BS to healthy male volunteers
- Conditions
- Healthy
- Being tested
- BI 44370 BS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 44370 BSDrug
| Study group | Role | What they receive |
|---|---|---|
| BI 44370 BS | Experimental | 200 mg containing 2.43 megabecquerel (MBq) 14C-radioactivity Receives: Drug: BI 44370 BS |
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
in nmoleq/L
Measured: up to day 15
Individual time course profiles of [14C]-radioactivity in faeces
in nmoleq/kg
Measured: up to day 15
Individual time course profiles of BI 44370 BS (and its glucuronide CD 10419 BS) in plasma and urine
Measured: up to 15 days
Rate and extent of excretion mass balance based on the total radioactivity in urine and faeces
Measured: up to 15 days
Cblood cells/Cplasma ratio of [14C]-radioactivity
Measured: up to 12 hours after drug administration
Cblood /Cplasma ratio of [14C]-radioactivity
Measured: up to 144 hours after drug administration
Identification of major metabolites in plasma, urine, and faeces
Measured: up to day 15
Cmax (maximum concentration of the analyte(s) in plasma)
Measured: up to 144 hours after drug administration
tmax (time from dosing to the maximum concentration of the analyte(s) in plasma)
Measured: up to 144 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 144 hours after drug administration
AUC0-inf. (area under the concentration-time curve of the analyte(s) in plasma over the time interval from 0 to infinity)
Measured: up to 144 hours after drug administration
λz (terminal rate constant in plasma)
Measured: up to 144 hours after drug administration
t1/2 (terminal half-life of the analyte(s) in plasma)
Measured: up to 144 hours after drug administration
MRTpo (mean residence time of the analyte(s) in the body after oral administration)
Measured: up to 144 hours after drug administration
CL/F (total clearance of the analyte in plasma after oral administration)
Measured: up to 144 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an oral dose)
Measured: up to 144 hours after drug administration
Ae0-tz (amount of analyte that is eliminated in urine within the time interval zero to tz, additionally excretion within each sampling interval will be calculated)
Measured: up to 15 days
fe0-tz (fraction of analyte excreted in urine within the time interval zero to tz in % of dose, additionally excretion within each sampling interval will be calculated)
Measured: up to 15 days
Aefaeces,0-tz (amount of analyte excreted in faeces within the time interval zero to tz, additionally excretion within each sampling interval will be calculated)
Measured: up to 15 days
fefaeces,0-tz (fraction 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 15 days
CLR,t1-t2 (renal clearance of analyte from the within the time interval t1 to t2)
Measured: up to 15 days
Secondary outcomes (5)
Number of patients with clinically relevant findings in vital signs
Measured: up to 23 days
Number of patients with clinically relevant findings in 12-lead electrocardiogram (ECG)
Measured: up to 23 days
Number of patients with clinically relevant laboratory findings
Measured: up to 23 days
Number of patients with adverse events
Measured: up to up to 44 days
Assessment of global tolerability on a 4-point scale
Measured: day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startSep 2008
- Primary completionOct 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
- 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
- NCT02215772
- Sponsor's protocol ID
- 1246.14
- Status last verified
- Aug 2014
- First submitted
- 12 Aug 2014
- Last updated
- 13 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial to Investigate the Metabolism and Pharmacokinetics of an Open Label Single Dose of 200 mg [14C]-BI 44370 BS Administered as an Oral Solution in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02215772
- Acronym / sponsor ID
- 1246.14
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Oct 2008 (actual)
- First posted
- 13 Aug 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 to investigate the basic pharmacokinetics of BI 44370 BS, its metabolite CD 10419 BS, and 14C-radioactivity including mass balance, excretion pathways, and metabolism following a single oral administration of 200 mg [14C]BI 44370 BS to healthy male volunteers and to evaluate safety and tolerability following a single oral administration of 200 mg [14C]BI 44370 BS to healthy male volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BI 44370 BS | Experimental | Drug: BI 44370 BS200 mg containing 2.43 megabecquerel (MBq) 14C-radioactivity |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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 ECG, clinical laboratory tests
- Age ≥18 and ≤65 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 (24 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 44370 BS | Drug | BI 44370 BS |
Primary outcome
Individual time course profiles of [14C]-radioactivity in whole blood, plasma, urine
Time frame: up to day 15
in nmoleq/L
Individual time course profiles of [14C]-radioactivity in faeces
Time frame: up to day 15
in nmoleq/kg
Individual time course profiles of BI 44370 BS (and its glucuronide CD 10419 BS) in plasma and urine
Time frame: up to 15 days
Rate and extent of excretion mass balance based on the total radioactivity in urine and faeces
Time frame: up to 15 days
Cblood cells/Cplasma ratio of [14C]-radioactivity
Time frame: up to 12 hours after drug administration
Cblood /Cplasma ratio of [14C]-radioactivity
Time frame: up to 144 hours after drug administration
Identification of major metabolites in plasma, urine, and faeces
Time frame: up to day 15
Cmax (maximum concentration of the analyte(s) in plasma)
Time frame: up to 144 hours after drug administration
tmax (time from dosing to the maximum concentration of the analyte(s) in plasma)
Time frame: up to 144 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 144 hours after drug administration
AUC0-inf. (area under the concentration-time curve of the analyte(s) in plasma over the time interval from 0 to infinity)
Time frame: up to 144 hours after drug administration
λz (terminal rate constant in plasma)
Time frame: up to 144 hours after drug administration
t1/2 (terminal half-life of the analyte(s) in plasma)
Time frame: up to 144 hours after drug administration
MRTpo (mean residence time of the analyte(s) in the body after oral administration)
Time frame: up to 144 hours after drug administration
CL/F (total clearance of the analyte in plasma after oral administration)
Time frame: up to 144 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an oral dose)
Time frame: up to 144 hours after drug administration
Ae0-tz (amount of analyte that is eliminated in urine within the time interval zero to tz, additionally excretion within each sampling interval will be calculated)
Time frame: up to 15 days
fe0-tz (fraction of analyte excreted in urine within the time interval zero to tz in % of dose, additionally excretion within each sampling interval will be calculated)
Time frame: up to 15 days
Aefaeces,0-tz (amount of analyte excreted in faeces within the time interval zero to tz, additionally excretion within each sampling interval will be calculated)
Time frame: up to 15 days
fefaeces,0-tz (fraction 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 15 days
CLR,t1-t2 (renal clearance of analyte from the within the time interval t1 to t2)
Time frame: up to 15 days
5 secondary outcomes
Number of patients with clinically relevant findings in vital signs
Time frame: up to 23 days
Number of patients with clinically relevant findings in 12-lead electrocardiogram (ECG)
Time frame: up to 23 days
Number of patients with clinically relevant laboratory findings
Time frame: up to 23 days
Number of patients with adverse events
Time frame: up to up to 44 days
Assessment of global tolerability on a 4-point scale
Time frame: 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 13 Aug 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 BI 44370 BS 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 24 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 13 Aug 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 (time frame: up to day 15). The study lists 21 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 13 Aug 2014.