HealthyPhase 1NCT02183662
Safety and Pharmacokinetics of Single Rising Oral Doses of BI 224436 ZW in Healthy Male Volunteers.
A Phase 1 study testing BI 224436 in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To investigate safety and pharmacokinetics of BI 224436 ZW Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 224436
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Mar 2010
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males
- Age ≥21 and Age ≤50 years
- Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 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 blood pressure (BP), pulse rate (PR) and electrocardiogram (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
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
Show all 21Show fewer
- HIV infection and other chronic or relevant acute infections
- 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 within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within one month prior to administration or during the trial
- Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
- Inability to refrain from smoking on trial days
- 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 treatment period)
- Any laboratory value outside the reference range that is of clinical relevance
- A baseline prolongation of QT/QTc interval (e.g., a QTc interval ≥450 ms)
- A history of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- Bradycardia (PR <60 beats/min)
About this study
Official title: Safety and Pharmacokinetics of Single Rising Oral Doses of BI 224436 ZW at 6.2 mg, 12.5 mg, 25 mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg and 1200 mg Dose Levels in Healthy Male Volunteers (Randomized, Double-blind, Placebo-controlled Within Dose Groups)
To investigate safety and pharmacokinetics of BI 224436 ZW
- Conditions
- Healthy
- Being tested
- BI 224436, Placebo to BI 224436
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 224436Drug
Placebo to BI 224436Drug
| Study group | Role | What they receive |
|---|---|---|
| BI 224436 | Experimental | Not described Receives: Drug: BI 224436 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo to BI 224436 |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum measured concentration of the analyte in plasma
Measured: up to 72 hours
area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 24
Measured: up to 24 hours
Secondary outcomes (18)
area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity
Measured: up to 72 hours
minimum observed concentration at 24 hours
Measured: up to 24 hours
terminal half-life of the analyte in plasma
Measured: up to 72 hours
time from dosing to maximum measured concentration of the analyte in plasma
Measured: up to 72 hours
apparent clearance of the analyte in plasma
Measured: up to 72 hours
apparent volume of distribution during the terminal phase λz
Measured: up to 72 hours
apparent volume of distribution
Measured: up to 72 hours
mean residence time of the analyte in the body after single oral administration
Measured: up to 72 hours
terminal rate constant in plasma
Measured: up to 72 hours
the last measurable concentration in the concentration-time profile
Measured: up to 72 hours
the extrapolated Area under the curve from the time of the last measurable concentration in the concentration-time profile to infinity
Measured: up to 72 hours
the percentage of the Area under the concentration-time curve until infinity, that is determined by extrapolation
Measured: up to 72 hours
amount of analyte that is eliminated in urine from the time point t0 to time point t4
Measured: up to 4 hours
amount of analyte that is eliminated in urine from the time point t4 to time point t8
Measured: from 4 to 8 hours
amount of analyte that is eliminated in urine from the time point t8 to time point t12
Measured: from 8 to 12 hours
amount of analyte that is eliminated in urine from the time point t12 to time point t24
Measured: from 12 to 24 hours
fraction of analyte eliminated in urine from time point t0 to time point t24
Measured: up to 24 hours
renal clearance of the analyte from the time point t0 until the time point t24
Measured: up to 24 hours
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 startNov 2009
- Primary completionMar 2010
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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 105 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
- NCT02183662
- Sponsor's protocol ID
- 1277.1
- 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
- Safety and Pharmacokinetics of Single Rising Oral Doses of BI 224436 ZW at 6.2 mg, 12.5 mg, 25 mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg and 1200 mg Dose Levels in Healthy Male Volunteers (Randomized, Double-blind, Placebo-controlled Within Dose Groups)
- ClinicalTrials.gov ID
- NCT02183662
- Acronym / sponsor ID
- 1277.1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Mar 2010 (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 investigate safety and pharmacokinetics of BI 224436 ZW
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 224436 | Experimental | Drug: BI 224436 |
| Placebo | Placebo comparator | Drug: Placebo to BI 224436 |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males
- Age ≥21 and Age ≤50 years
- Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 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 (21 listed)
- Any finding of the medical examination (including blood pressure (BP), pulse rate (PR) and electrocardiogram (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
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological 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 |
|---|---|---|
| BI 224436 | Drug | BI 224436 |
| Placebo to BI 224436 | Drug | Placebo |
Primary outcome
maximum measured concentration of the analyte in plasma
Time frame: up to 72 hours
area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 24
Time frame: up to 24 hours
18 secondary outcomes
area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity
Time frame: up to 72 hours
minimum observed concentration at 24 hours
Time frame: up to 24 hours
terminal half-life of the analyte in plasma
Time frame: up to 72 hours
time from dosing to maximum measured concentration of the analyte in plasma
Time frame: up to 72 hours
apparent clearance of the analyte in plasma
Time frame: up to 72 hours
apparent volume of distribution during the terminal phase λz
Time frame: up to 72 hours
apparent volume of distribution
Time frame: up to 72 hours
mean residence time of the analyte in the body after single oral administration
Time frame: up to 72 hours
terminal rate constant in plasma
Time frame: up to 72 hours
the last measurable concentration in the concentration-time profile
Time frame: up to 72 hours
the extrapolated Area under the curve from the time of the last measurable concentration in the concentration-time profile to infinity
Time frame: up to 72 hours
the percentage of the Area under the concentration-time curve until infinity, that is determined by extrapolation
Time frame: up to 72 hours
amount of analyte that is eliminated in urine from the time point t0 to time point t4
Time frame: up to 4 hours
amount of analyte that is eliminated in urine from the time point t4 to time point t8
Time frame: from 4 to 8 hours
amount of analyte that is eliminated in urine from the time point t8 to time point t12
Time frame: from 8 to 12 hours
amount of analyte that is eliminated in urine from the time point t12 to time point t24
Time frame: from 12 to 24 hours
fraction of analyte eliminated in urine from time point t0 to time point t24
Time frame: up to 24 hours
renal clearance of the analyte from the time point t0 until the time point t24
Time frame: up to 24 hours
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.
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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 224436 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 21 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. Some participants in this study may receive a placebo. 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?
maximum measured concentration of the analyte in plasma (time frame: up to 72 hours). The study lists 2 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.