HealthyPhase 1NCT02182388
Single Rising Oral Doses of BI 207127 NA as Powder in the Bottle in Healthy Male Subjects
A Phase 1 study testing BI 207127 NA powder for solution and BI 207127 NA tablet in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The objective of this trial was to investigate the safety, tolerability, pharmacokinetics, and relative bioavailability of BI 207127 NA as powder in the bottle (PIB) and solid oral dosage form (tablets) without and with food. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 207127 NA powder for solution and BI 207127 NA tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to May 2007
- 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 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 ≥18 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 nerve 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)
- Inability to refrain from alcohol on trial days
- 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
- Baseline prolongation of QTc interval >450 ms
- A history of additional risk factors for TdP (Torsades de points) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
About this study
Official title: Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses (5 mg to 3000 mg) of BI 207127 NA as Powder in the Bottle Reconstituted With PEG 400/Tris/SDS in Healthy Male Subjects. A Randomised, Placebo-controlled and Within Dose Groups Double-blinded Trial. Followed by an Intra-individual, Partially Randomised, Open Comparison of Powder in the Bottle and Tablet Without and With Food.
The objective of this trial was to investigate the safety, tolerability, pharmacokinetics, and relative bioavailability of BI 207127 NA as powder in the bottle (PIB) and solid oral dosage form (tablets) without and with food.
- Conditions
- Healthy
- Being tested
- Placebo, BI 207127 NA powder for solution, BI 207127 NA tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
BI 207127 NA powder for solutionDrug
BI 207127 NA tabletDrug
| Study group | Role | What they receive |
|---|---|---|
| BI 207127 NA | Experimental | single rising dose part Receives: Drug: BI 207127 NA powder for solution |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| BI 207127 NA, fasted or fed | Experimental | Not described Receives: Drug: BI 207127 NA powder for solution; Drug: BI 207127 NA tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with abnormal findings in physical examination
Measured: Baseline, within 14 days after last trial procedure
Number of patients with clinically significant changes in vital signs (blood pressure (BP), pulse rate (PR)
Measured: Baseline, up to 14 days after last trial procedure
Number of patients with clinically relevant findings in 12-lead ECG (electrocardiogram)
Measured: Baseline, up to 14 days after last trial procedure
Number of patients with abnormal changes in clinical laboratory tests
Measured: Baseline, up to 14 days after last trial procedure
Number of patients with adverse events
Measured: up to 44 days
Assessment of tolerability on a 4-point scale by investigator
Measured: within 14 days after last trial procedure
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 the analyte in plasma over the time interval from 0 extrapolated to the last observed plasma concentration)
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 (apparent clearance of the analyte in plasma after oral administration)
Measured: up to 72 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an oral 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 48 hours after drug administration
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Measured: up to 48 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 48 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 posted8 Jul 2014 (estimated)
- Study startJan 2007
- Primary completionMay 2007
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
- 82 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
- NCT02182388
- Sponsor's protocol ID
- 1241.1
- 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
- Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses (5 mg to 3000 mg) of BI 207127 NA as Powder in the Bottle Reconstituted With PEG 400/Tris/SDS in Healthy Male Subjects. A Randomised, Placebo-controlled and Within Dose Groups Double-blinded Trial. Followed by an Intra-individual, Partially Randomised, Open Comparison of Powder in the Bottle and Tablet Without and With Food.
- ClinicalTrials.gov ID
- NCT02182388
- Acronym / sponsor ID
- 1241.1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- May 2007 (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.
The objective of this trial was to investigate the safety, tolerability, pharmacokinetics, and relative bioavailability of BI 207127 NA as powder in the bottle (PIB) and solid oral dosage form (tablets) without and with food.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BI 207127 NA | Experimental | Drug: BI 207127 NA powder for solutionsingle rising dose part |
| Placebo | Placebo comparator | Drug: Placebo |
| BI 207127 NA, fasted or fed | Experimental | Drug: BI 207127 NA powder for solution, Drug: BI 207127 NA tablet |
Who may qualify
- Ages
- 18 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 ≥18 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 nerve 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 |
|---|---|---|
| Placebo | Drug | Placebo |
| BI 207127 NA powder for solution | Drug | BI 207127 NA, BI 207127 NA, fasted or fed |
| BI 207127 NA tablet | Drug | BI 207127 NA, fasted or fed |
Primary outcome
Number of patients with abnormal findings in physical examination
Time frame: Baseline, within 14 days after last trial procedure
Number of patients with clinically significant changes in vital signs (blood pressure (BP), pulse rate (PR)
Time frame: Baseline, up to 14 days after last trial procedure
Number of patients with clinically relevant findings in 12-lead ECG (electrocardiogram)
Time frame: Baseline, up to 14 days after last trial procedure
Number of patients with abnormal changes in clinical laboratory tests
Time frame: Baseline, up to 14 days after last trial procedure
Number of patients with adverse events
Time frame: up to 44 days
Assessment of tolerability on a 4-point scale by investigator
Time frame: within 14 days after last trial procedure
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 the analyte in plasma over the time interval from 0 extrapolated to the last observed plasma concentration)
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 (apparent clearance of the analyte in plasma after oral administration)
Time frame: up to 72 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an oral 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 48 hours after 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 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 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 BI 207127 NA powder for solution and BI 207127 NA tablet 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 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. 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 patients with abnormal findings in physical examination (time frame: Baseline, within 14 days after last trial procedure). 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 18 Jul 2014.