HealthyPhase 1NCT02259972
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 113823 Powder in Bottle (PiB) and Tablet in Healthy Male Volunteers
A Phase 1 study testing BI 113823 solution, BI 113823 tablet and High fat, high calorie breakfast in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To investigate the safety, tolerability, and pharmacokinetics incl. dose proportionality of BI 113823, as well as the relative bioavailability of PiB vs. tablet and tablet fasted vs. fed (food effect for the tablet). Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 113823 solution, BI 113823 tablet and High fat, high calorie breakfast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jun 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- 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 ECG, clinical laboratory tests
- Age ≥18 and Age ≤45 years
- BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with 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
- 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
- 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
- Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration
- 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 on trial days
- Alcohol abuse (more than 30 g/day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration)
- Excessive physical activities (within one week prior to administration)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of trial site
- Bradycardia < 50/min, PR interval > 200 ms, QRS interval > 110 ms, QTcB > 450 ms, or QT (uncorrected) > 470 ms or any other relevant ECG findings at screening
- A history of additional risk factors for Torsades des Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
About this study
Official title: Investigation of Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of 5 to 800 mg BI 113823 Powder in Bottle (PiB) and Tablet Administered to Healthy Male Volunteers in a Partially Randomised and Double Blinded, Placebo Controlled Phase I Trial. Including Intra-individual Open Comparisons of PiB and Tablet (Fasted and Fed).
To investigate the safety, tolerability, and pharmacokinetics incl. dose proportionality of BI 113823, as well as the relative bioavailability of PiB vs. tablet and tablet fasted vs. fed (food effect for the tablet).
- Conditions
- Healthy
- Being tested
- BI 113823 solution, BI 113823 tablet, Placebo, High fat, high calorie breakfast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 113823 solutionDrug
BI 113823 tabletDrug
PlaceboDrug
High fat, high calorie breakfastOther
only for dose group 5
| Study group | Role | What they receive |
|---|---|---|
| BI 113823 solution | Experimental | single rising doses, dose group 5 twice (fed and fasted) Receives: Drug: BI 113823 solution; Other: High fat, high calorie breakfast |
| BI 113823 tablet | Experimental | dose group 5 only Receives: Drug: BI 113823 tablet; Other: High fat, high calorie breakfast |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with clinically significant findings on physical examination
Measured: up to 14 days after last drug administration
Number of participants with clinically significant findings in vital signs
blood pressure (BP), pulse rate (PR)
Measured: up to 14 days after last drug administration
Number of participants with clinically significant findings in 12-lead electrocardiogram (ECG)
special attention to QRS prolongation
Measured: up to 14 days after last drug administration
Number of participants with clinically significant findings in laboratory tests
Measured: up to 14 days after last drug administration
Number of participants with adverse events
Measured: up to 14 days after last drug administration
Assessment of tolerability by investigator on a 4-point scale
Measured: up to 14 days after last drug administration
Secondary outcomes (12)
Cmax (maximum measured concentration of the analyte in plasma)
Measured: up to 72 hours after drug administration
tmax (time from dosing to maximum measured concentration)
Measured: up to 72 hours after drug administration
AUC0-∞ (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 after drug administration
AUC0-tz (area under the concentration-time curve of metformin in plasma over the time interval from 0 to the time of the last quantifiable data point)
Measured: up to 72 hours after drug administration
λz (terminal rate constant in plasma)
Measured: up to 72 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Measured: up to 72 hours after drug administration
MRToral (mean residence time of the analyte in the body after oral administration)
Measured: up to 72 hours after drug administration
CL/F (total/apparent clearance of the analyte in plasma after extravascular administration)
Measured: up to 72 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Measured: up to 72 hours after drug administration
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
Measured: up to 72 hours after drug administration
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Measured: up to 72 hours after drug administration
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Measured: up to 72 hours 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 posted9 Oct 2014 (estimated)
- Study startJan 2010
- Primary completionJun 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 63 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
- NCT02259972
- Sponsor's protocol ID
- 1272.1
- Status last verified
- Oct 2014
- First submitted
- 7 Oct 2014
- Last updated
- 9 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of 5 to 800 mg BI 113823 Powder in Bottle (PiB) and Tablet Administered to Healthy Male Volunteers in a Partially Randomised and Double Blinded, Placebo Controlled Phase I Trial. Including Intra-individual Open Comparisons of PiB and Tablet (Fasted and Fed).
- ClinicalTrials.gov ID
- NCT02259972
- Acronym / sponsor ID
- 1272.1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Jun 2010 (actual)
- First posted
- 9 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.
To investigate the safety, tolerability, and pharmacokinetics incl. dose proportionality of BI 113823, as well as the relative bioavailability of PiB vs. tablet and tablet fasted vs. fed (food effect for the tablet).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BI 113823 solution | Experimental | Drug: BI 113823 solution, Other: High fat, high calorie breakfastsingle rising doses, dose group 5 twice (fed and fasted) |
| BI 113823 tablet | Experimental | Drug: BI 113823 tablet, Other: High fat, high calorie breakfastdose group 5 only |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- 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 (BP, PR), 12-lead ECG, clinical laboratory tests
- Age ≥18 and Age ≤45 years
- BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation
Key exclusion criteria (21 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
- 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 113823 solution | Drug | BI 113823 solution |
| BI 113823 tablet | Drug | BI 113823 tablet |
| Placebo | Drug | Placebo |
| High fat, high calorie breakfastonly for dose group 5 | Other | BI 113823 solution, BI 113823 tablet |
Primary outcome
Number of participants with clinically significant findings on physical examination
Time frame: up to 14 days after last drug administration
Number of participants with clinically significant findings in vital signs
Time frame: up to 14 days after last drug administration
blood pressure (BP), pulse rate (PR)
Number of participants with clinically significant findings in 12-lead electrocardiogram (ECG)
Time frame: up to 14 days after last drug administration
special attention to QRS prolongation
Number of participants with clinically significant findings in laboratory tests
Time frame: up to 14 days after last drug administration
Number of participants with adverse events
Time frame: up to 14 days after last drug administration
Assessment of tolerability by investigator on a 4-point scale
Time frame: up to 14 days after last drug administration
12 secondary outcomes
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 72 hours after drug administration
tmax (time from dosing to maximum measured concentration)
Time frame: up to 72 hours after drug administration
AUC0-∞ (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 after drug administration
AUC0-tz (area under the concentration-time curve of metformin in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: up to 72 hours after drug administration
λz (terminal rate constant in plasma)
Time frame: up to 72 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 72 hours after drug administration
MRToral (mean residence time of the analyte in the body after oral administration)
Time frame: up to 72 hours after drug administration
CL/F (total/apparent clearance of the analyte in plasma after extravascular administration)
Time frame: up to 72 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 72 hours after drug administration
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
Time frame: up to 72 hours after drug administration
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Time frame: up to 72 hours after drug administration
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Time frame: up to 72 hours 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 9 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 BI 113823 solution, BI 113823 tablet and High fat, high calorie breakfast 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 9 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. 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?
Number of participants with clinically significant findings on physical examination (time frame: up to 14 days after last drug administration). The study lists 6 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 9 Oct 2014.