HealthyPhase 1NCT02182154
Metabolism and Pharmacokinetics of [14C]-BIBF 1120 in Healthy Male Volunteers
A Phase 1 study testing BIBF 1120 ES in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To assess the metabolic profile, to obtain the mass balance after oral administration, to determine the concentration of [14C]-radioactivity in blood cells, plasma, urine and faeces, to determine BIBF 1120 and BIBF 1202 concentrations in plasma, urine, and faeces, if feasible, to determine the protein binding of… Read more about this study
- Who is it for?
- Ages 21 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BIBF 1120 ES
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to Nov 2005
- 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 21 to 55 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 GCP and local legislation
- Age ≥21 and ≤55 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 19Show fewer
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- History of any bleeding disorder including prolonged or habitual bleeding, other haematologic disease or cerebral bleeding (e.g. after a car accident) or commotio cerebri
- 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
- Female gender
- 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]-BIBF 1120 After Administration of Single Doses of 100 mg [14C]-BIBF 1120 Oral Solution in Healthy Male Volunteers
To assess the metabolic profile,
to obtain the mass balance after oral administration,
to determine the concentration of [14C]-radioactivity in blood cells, plasma, urine and faeces,
to determine BIBF 1120 and BIBF 1202 concentrations in plasma, urine, and faeces, if feasible,
to determine the protein binding of [14C]-radioactivity,
to determine the pharmacokinetics of BIBF 1120, BIBF 1202 and total radioactivity after a single oral administration of [14C]-BIBF 1120 in healthy volunteers
- Conditions
- Healthy
- Being tested
- BIBF 1120 ES
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBF 1120 ESDrug
| Study group | Role | What they receive |
|---|---|---|
| BIBF 1120 ES | Experimental | Not described Receives: Drug: BIBF 1120 ES |
What is being measured
The primary outcome is the main question the study is designed to answer.
[14C]-radioactivity in plasma and whole blood (C Blood cells/C plasma ratio of [14C]-radioactivity)
Measured: Up to 96 h after drug administration
[14C]-radioactivity in urine
Measured: Up to 120 h after drug administration
Measurement of the plasma protein binding of total [14C]-radioactivity in human plasma samples ex vivo
Measured: Up to 96 h after drug administration
Maximum observed concentration of the analyte in plasma (Cmax)
Measured: Up to 96 h after drug administration
Plasma concentration-time profiles of total radioactivity in whole blood and plasma
Measured: Up to 96 h after drug administration
[14C]-metabolic profile and identification of metabolites in urine, in comparison with various animal species
Measured: Up to 120 h after drug aministration
[14C]-radioactivity in faeces
Measured: up to 120 h after administration
[14C]-metabolic profile and identification of metabolites in faeces, in comparison with various animal species
Measured: Up to 120 h after drug aministration
[14C]-metabolic profile and identification of metabolites in plasma, in comparison with various animal species
Measured: Up to 96 h after drug aministration
Time from dosing to peak concentration (tmax)
Measured: Up to 96 h after drug administration
Terminal half-life of the analyte in plasma (t1/2)
Measured: Up to 96 h after drug administration
Terminal rate constant of the analyte in plasma (λz)
Measured: Up to 96 h after drug administration
Area under the concentration-time curve of the analyte in plasma from zero time to 24 hours (AUC0-24)
Measured: Up to 24 h after drug administration
Area under the concentration-time curve of the analyte in plasma from zero time to the time of the last quantifiable drug concentration (AUC0-tz)
Measured: Up to 96 h after drug administration
Area under the concentration-time curve of the analyte in plasma from zero time to infinity (AUC0-∞)
Measured: Up to 96 h after drug administration
Mean residence time of the analyte molecules in the body after oral administration (MRTpo)
Measured: Up to 96 h after drug administration
Total clearance of the analyte in plasma following extravascular administration (CL/F)
Measured: Up to 96 h after drug administration
Apparent volume of distribution during the terminal phase λz following extravascular administration (Vz/F)
Measured: Up to 96 h after drug administration
Fraction of analyte eliminated in urine from 0 to the limit of the last quantifiable data point (fe0-tz)
Measured: Up to 96 h after drug administration
Fraction of analyte eliminated in faeces from 0 to the limit of the last quantifiable data point (fe faeces,0-tz)
Measured: Up to 96 h after drug administration
Amount of analyte that was eliminated in faeces from 0 to the limit of the last quantifiable data point (Ae faeces,0-tz)
Measured: Up to 96 h after drug administration
Amount of analyte that was eliminated in urine from 0 to the limit of the last quantifiable data point (Ae0-tz)
Measured: Up to 96 h after drug administration
Secondary outcomes (5)
Change from baseline in vital signs
Measured: Baseline, day 14 after drug administration
Change from baseline in routine laboratory
Measured: Baseline, day 14 after drug aministration
Number of participants with adverse events
Measured: Up to day 14 after drug aministration
Change from baseline in electrocardiogram
Measured: Baseline, day 14 after drug aministration
Assessment of tolerability by investigator according a 4 point scale
Measured: Day 14 after 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 Jul 2014 (estimated)
- Study startOct 2005
- Primary completionNov 2005
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
- NCT02182154
- Sponsor's protocol ID
- 1199.20
- Status last verified
- Jul 2014
- First submitted
- 2 Jul 2014
- Last updated
- 18 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolism and Pharmacokinetics of [14C]-BIBF 1120 After Administration of Single Doses of 100 mg [14C]-BIBF 1120 Oral Solution in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02182154
- Acronym / sponsor ID
- 1199.20
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Nov 2005 (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 assess the metabolic profile,
to obtain the mass balance after oral administration,
to determine the concentration of [14C]-radioactivity in blood cells, plasma, urine and faeces,
to determine BIBF 1120 and BIBF 1202 concentrations in plasma, urine, and faeces, if feasible,
to determine the protein binding of [14C]-radioactivity,
to determine the pharmacokinetics of BIBF 1120, BIBF 1202 and total radioactivity after a single oral administration of [14C]-BIBF 1120 in healthy volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIBF 1120 ES | Experimental | Drug: BIBF 1120 ES |
Who may qualify
- Ages
- 21 to 55 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 GCP and local legislation
- Age ≥21 and ≤55 years
- Body Mass Index ≥18.5 kg/m2 and ≤29.9 kg/m2
Key exclusion criteria (19 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 |
|---|---|---|
| BIBF 1120 ES | Drug | BIBF 1120 ES |
Primary outcome
[14C]-radioactivity in plasma and whole blood (C Blood cells/C plasma ratio of [14C]-radioactivity)
Time frame: Up to 96 h after drug administration
[14C]-radioactivity in urine
Time frame: Up to 120 h after drug administration
Measurement of the plasma protein binding of total [14C]-radioactivity in human plasma samples ex vivo
Time frame: Up to 96 h after drug administration
Maximum observed concentration of the analyte in plasma (Cmax)
Time frame: Up to 96 h after drug administration
Plasma concentration-time profiles of total radioactivity in whole blood and plasma
Time frame: Up to 96 h after drug administration
[14C]-metabolic profile and identification of metabolites in urine, in comparison with various animal species
Time frame: Up to 120 h after drug aministration
[14C]-radioactivity in faeces
Time frame: up to 120 h after administration
[14C]-metabolic profile and identification of metabolites in faeces, in comparison with various animal species
Time frame: Up to 120 h after drug aministration
[14C]-metabolic profile and identification of metabolites in plasma, in comparison with various animal species
Time frame: Up to 96 h after drug aministration
Time from dosing to peak concentration (tmax)
Time frame: Up to 96 h after drug administration
Terminal half-life of the analyte in plasma (t1/2)
Time frame: Up to 96 h after drug administration
Terminal rate constant of the analyte in plasma (λz)
Time frame: Up to 96 h after drug administration
Area under the concentration-time curve of the analyte in plasma from zero time to 24 hours (AUC0-24)
Time frame: Up to 24 h after drug administration
Area under the concentration-time curve of the analyte in plasma from zero time to the time of the last quantifiable drug concentration (AUC0-tz)
Time frame: Up to 96 h after drug administration
Area under the concentration-time curve of the analyte in plasma from zero time to infinity (AUC0-∞)
Time frame: Up to 96 h after drug administration
Mean residence time of the analyte molecules in the body after oral administration (MRTpo)
Time frame: Up to 96 h after drug administration
Total clearance of the analyte in plasma following extravascular administration (CL/F)
Time frame: Up to 96 h after drug administration
Apparent volume of distribution during the terminal phase λz following extravascular administration (Vz/F)
Time frame: Up to 96 h after drug administration
Fraction of analyte eliminated in urine from 0 to the limit of the last quantifiable data point (fe0-tz)
Time frame: Up to 96 h after drug administration
Fraction of analyte eliminated in faeces from 0 to the limit of the last quantifiable data point (fe faeces,0-tz)
Time frame: Up to 96 h after drug administration
Amount of analyte that was eliminated in faeces from 0 to the limit of the last quantifiable data point (Ae faeces,0-tz)
Time frame: Up to 96 h after drug administration
Amount of analyte that was eliminated in urine from 0 to the limit of the last quantifiable data point (Ae0-tz)
Time frame: Up to 96 h after drug administration
5 secondary outcomes
Change from baseline in vital signs
Time frame: Baseline, day 14 after drug administration
Change from baseline in routine laboratory
Time frame: Baseline, day 14 after drug aministration
Number of participants with adverse events
Time frame: Up to day 14 after drug aministration
Change from baseline in electrocardiogram
Time frame: Baseline, day 14 after drug aministration
Assessment of tolerability by investigator according a 4 point scale
Time frame: Day 14 after 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 18 Jul 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 BIBF 1120 ES 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 19 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 18 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?
[14C]-radioactivity in plasma and whole blood (C Blood cells/C plasma ratio of [14C]-radioactivity) (time frame: Up to 96 h after 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 18 Jul 2014.