HealthyPhase 1NCT02259842
Safety, Tolerability and Pharmacokinetics of BI 34021 FU2 Oral Drinking Solution in Healthy Male Volunteers
A Phase 1 study testing BI 34021 FU2 solution, BI 34021 FU2 tablet and High fat, high calorie breakfast in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Evaluation of safety, tolerability and PK of single rising oral doses of BI 34021 FU2 in healthy male volunteers; comparison of 100 mg drinking solution vs. tablet, assessment of food effect by re-dosing at 50 mg and 150 mg 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 34021 FU2 solution, BI 34021 FU2 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
- Mar 2008to Jun 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 21 to 50 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 ≥21 and Age ≤50 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 Good Clinical Practice 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 22Show 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 or during the trial
- 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 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 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 trial)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of trial site
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
- A history of additional risk factors for Torsade des Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- Not willing to use adequate contraception (condom use plus another form of contraception e.g. spermicide, oral contraceptive taken by female partner, sterilisation, intrauterine device (IUD) 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: Safety, Tolerability and Pharmacokinetics of BI 34021 FU2 Oral Drinking Solution in Healthy Male Volunteers (Dose Range: 5 - 500 mg). A Double-blind (Within Dose Groups), Randomised, Placebo-controlled Within Dose Groups, Single Rising Dose Study, Including Re-dosing at 50 mg and 150 mg (Food Effect) and at 100 mg (Two 50 mg Tablets)
Evaluation of safety, tolerability and PK of single rising oral doses of BI 34021 FU2 in healthy male volunteers; comparison of 100 mg drinking solution vs. tablet, assessment of food effect by re-dosing at 50 mg and 150 mg
- Conditions
- Healthy
- Being tested
- BI 34021 FU2 solution, BI 34021 FU2 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 34021 FU2 solutionDrug
BI 34021 FU2 tabletDrug
dose group 4 only
PlaceboDrug
High fat, high calorie breakfastOther
only for dose groups 3 and 5
| Study group | Role | What they receive |
|---|---|---|
| BI 34021 FU2 solution | Experimental | single rising doses, dose groups 3 and 5 double-dosing (fed and fasted) Receives: Drug: BI 34021 FU2 solution; Other: High fat, high calorie breakfast |
| BI 34021 FU2 tablet | Experimental | dose group 4 only Receives: Drug: BI 34021 FU2 tablet |
| 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 10 days after last drug administration
Number of participants with clinically significant findings in vital signs
blood pressure (BP), pulse rate (PR) respiratory rate (RR), oral body temperature, orthostatic test
Measured: up to 10 days after last drug administration
Number of participants with clinically significant findings in 12-lead electrocardiogram (ECG)
Measured: up to 10 days after last drug administration
Number of participants with clinically significant findings in laboratory tests
Measured: up to 10 days after last drug administration
Number of participants with clinically significant findings in safety markers
laboratory results for kidney and liver function
Measured: up to 10 days after last drug administration
Number of participants with adverse events
Measured: up to 10 days after last drug administration
Assessment of tolerability by investigator on a 4-point scale
Measured: up to 10 days after last drug administration
Secondary outcomes (14)
Cmax (maximum measured concentration of the analyte in plasma)
Measured: up to 72 hours after last drug administration
tmax (time from dosing to maximum measured concentration)
Measured: up to 72 hours after last 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 last drug administration
%AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)
Measured: up to 72 hours after last drug administration
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Measured: up to 72 hours after last drug administration
AUC0-2h (area under the concentration-time curve of the analytes in plasma over the time interval 0 to 2 hours after drug administration)
Measured: up to 2 hours after last drug administration
λz (terminal rate constant in plasma)
Measured: up to 72 hours after last drug administration
t1/2 (terminal half-life of the analyte in plasma)
Measured: up to 72 hours after last drug administration
MRTp.o. (mean residence time of the analyte in the body after p.o. administration)
Measured: up to 72 hours after last drug administration
CL/F (total/apparent clearance of the analyte in plasma after extravascular administration)
Measured: up to 72 hours after last drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Measured: up to 72 hours after last drug administration
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
Measured: up to 48 hours after last drug administration
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Measured: up to 48 hours after last drug administration
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Measured: up to 48 hours after last 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 startMar 2008
- Primary completionJun 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
- 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
- NCT02259842
- Sponsor's protocol ID
- 1258.1
- Status last verified
- Oct 2014
- First submitted
- 6 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
- Safety, Tolerability and Pharmacokinetics of BI 34021 FU2 Oral Drinking Solution in Healthy Male Volunteers (Dose Range: 5 - 500 mg). A Double-blind (Within Dose Groups), Randomised, Placebo-controlled Within Dose Groups, Single Rising Dose Study, Including Re-dosing at 50 mg and 150 mg (Food Effect) and at 100 mg (Two 50 mg Tablets)
- ClinicalTrials.gov ID
- NCT02259842
- Acronym / sponsor ID
- 1258.1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Jun 2008 (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.
Evaluation of safety, tolerability and PK of single rising oral doses of BI 34021 FU2 in healthy male volunteers; comparison of 100 mg drinking solution vs. tablet, assessment of food effect by re-dosing at 50 mg and 150 mg
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BI 34021 FU2 solution | Experimental | Drug: BI 34021 FU2 solution, Other: High fat, high calorie breakfastsingle rising doses, dose groups 3 and 5 double-dosing (fed and fasted) |
| BI 34021 FU2 tablet | Experimental | Drug: BI 34021 FU2 tabletdose group 4 only |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 50 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 ≥21 and Age ≤50 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 Good Clinical Practice and the local legislation
Key exclusion criteria (22 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 34021 FU2 solution | Drug | BI 34021 FU2 solution |
| BI 34021 FU2 tabletdose group 4 only | Drug | BI 34021 FU2 tablet |
| Placebo | Drug | Placebo |
| High fat, high calorie breakfastonly for dose groups 3 and 5 | Other | BI 34021 FU2 solution |
Primary outcome
Number of participants with clinically significant findings on physical examination
Time frame: up to 10 days after last drug administration
Number of participants with clinically significant findings in vital signs
Time frame: up to 10 days after last drug administration
blood pressure (BP), pulse rate (PR) respiratory rate (RR), oral body temperature, orthostatic test
Number of participants with clinically significant findings in 12-lead electrocardiogram (ECG)
Time frame: up to 10 days after last drug administration
Number of participants with clinically significant findings in laboratory tests
Time frame: up to 10 days after last drug administration
Number of participants with clinically significant findings in safety markers
Time frame: up to 10 days after last drug administration
laboratory results for kidney and liver function
Number of participants with adverse events
Time frame: up to 10 days after last drug administration
Assessment of tolerability by investigator on a 4-point scale
Time frame: up to 10 days after last drug administration
14 secondary outcomes
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 72 hours after last drug administration
tmax (time from dosing to maximum measured concentration)
Time frame: up to 72 hours after last 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 last drug administration
%AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)
Time frame: up to 72 hours after last drug administration
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: up to 72 hours after last drug administration
AUC0-2h (area under the concentration-time curve of the analytes in plasma over the time interval 0 to 2 hours after drug administration)
Time frame: up to 2 hours after last drug administration
λz (terminal rate constant in plasma)
Time frame: up to 72 hours after last drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 72 hours after last drug administration
MRTp.o. (mean residence time of the analyte in the body after p.o. administration)
Time frame: up to 72 hours after last drug administration
CL/F (total/apparent clearance of the analyte in plasma after extravascular administration)
Time frame: up to 72 hours after last drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 72 hours after last drug administration
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
Time frame: up to 48 hours after last drug administration
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Time frame: up to 48 hours after last drug administration
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Time frame: up to 48 hours after last 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 34021 FU2 solution, BI 34021 FU2 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 22 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 10 days after last drug administration). The study lists 7 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.