HealthyPhase 1NCT02182414
Relative Bioavailability of BI 207127 Trial Formulation II Prototypes Versus BI 207127 Trial Formulation I in Healthy Volunteers
A Phase 1 study testing BI 207127 NA (TF-I), BI 207127 NA (TF-II) and BI 207127 NA delayed release in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to investigate the relative bioavailability of 5 new 400 mg tablet formulations (trial formulation II prototypes) of BI 207127 compared to the current 200 mg BI 207127 tablet formulation (trial formulation I) in healthy male volunteers with the aim to identify the best formulation for further drug development… 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 (TF-I), BI 207127 NA (TF-II) and BI 207127 NA delayed release
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Sep 2009
- 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 a complete medical history, including a physical examination,vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
- Age 18 to 50 years, inclusive
- Body mass index 18.5 to 29.9 kg/m2, inclusive
- 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 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 prior to administration of the trial drug or during the trial
- Use of any drugs (including herbal preparations, vitamins and nutrient supplements) within 14 days prior to first administration of the trial drug or during the trial
- Participation in another trial with an investigational drug within two months prior to administration of the trial drug or during the trial
- Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- Alcohol abuse (more than 40 g/day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to first administration of the trial drug or during the trial)
- Excessive physical activities (within one week prior to first administration of the trial drug of the trial drug 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 de Points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- History of photosensitivity or recurrent rash
About this study
Official title: Relative Bioavailability of BI 207127 Trial Formulation II Prototypes Versus BI 207127 Trial Formulation I Administered Orally as Tablet in Single Doses of 800 mg to Healthy Volunteers, and Evaluation of the Effect of Food on the Bioavailability of a Selected Prototype (an Open-label, Two-stage, Within Parts Randomised Six-way and Two-way Crossover Phase I Study)
Study to investigate the relative bioavailability of 5 new 400 mg tablet formulations (trial formulation II prototypes) of BI 207127 compared to the current 200 mg BI 207127 tablet formulation (trial formulation I) in healthy male volunteers with the aim to identify the best formulation for further drug development (formulation finding part / trial part 1) and to investigate the effect of food on the relative bioavailability of the most promising one of these trial formulation II prototypes (food-effect part / trial part 2).
- Conditions
- Healthy
- Being tested
- BI 207127 NA (TF-I), BI 207127 NA (TF-II), BI 207127 NA delayed release, BI 207127 NA extended release (10% HPMC), BI 207127 NA extended release (15% PEO)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 207127 NA (TF-I)Drug
200 mg tablet
BI 207127 NA (TF-II)Drug
400 mg tablet
BI 207127 NA delayed releaseDrug
400 mg tablet
BI 207127 NA extended release (10% HPMC)Drug
400 mg tablet
BI 207127 NA extended release (15% PEO)Drug
400 mg tablet
BI 207127 NA extended release (20% HPMC)Drug
400 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| BI 207127 NA (TF-I) | Active comparator | trial part 1: 800 mg BI 207127 NA Trial formulation I (TF-I) Receives: Drug: BI 207127 NA (TF-I) |
| BI 207127 NA (TF-II) | Experimental | trial part 1: 800 mg BI 207127 NA Trial formulation II (TF-II) Receives: Drug: BI 207127 NA (TF-II) |
| BI 207127 NA delayed release | Experimental | trial part 1: 800 mg BI 207127 NA TF-II, delayed release Receives: Drug: BI 207127 NA delayed release |
| BI 207127 NA extended release (10% HPMC) | Experimental | trial part 1: 800 mg BI 207127 NA TF-II, extended release (10% Hydroxypropyl methyl cellulose (HPMC)) Receives: Drug: BI 207127 NA extended release (10% HPMC) |
| BI 207127 NA extended release (15% PEO) | Experimental | trial part 1: 800 mg BI 207127 NA TF-II, extended release (15% Polyethylene oxide (PEO)) Receives: Drug: BI 207127 NA extended release (15% PEO) |
| BI 207127 NA extended release (20% HPMC) | Experimental | trial part 1: 800 mg BI 207127 NA TF-II, extended release (20% HPMC) Receives: Drug: BI 207127 NA extended release (20% HPMC) |
| BI 207127 (TF-II), fed | Experimental | trial part 2 Receives: Drug: BI 207127 NA (TF-II); Drug: BI 207127 NA delayed release; Drug: BI 207127 NA extended release (10% HPMC); Drug: BI 207127 NA extended release (15% PEO); Drug: BI 207127 NA extended release (20% HPMC) |
| BI 207127 (TF-II), fasted | Experimental | trial part 2 Receives: Drug: BI 207127 NA (TF-II); Drug: BI 207127 NA delayed release; Drug: BI 207127 NA extended release (10% HPMC); Drug: BI 207127 NA extended release (15% PEO); Drug: BI 207127 NA extended release (20% HPMC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for BI 207127
Measured: up to 48 hours after drug administration
Cmax (maximum measured concentration of the analyte in plasma) for BI 207127
Measured: up to 48 hours after drug administration
Secondary outcomes (18)
AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval from t1 to t2)
Measured: up to 24 hours after drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Measured: up to 48 hours after drug administration
λz (terminal rate constant in plasma)
Measured: up to 48 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Measured: up to 48 hours after drug administration
MRTpo (mean residence time of the analyte in the body after p.o. administration)
Measured: up to 48 hours after drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Measured: up to 48 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Measured: up to 48 hours after drug administration
The fluctuation parameter Cmax/C12 for the ER (Extended release) formulations only
Measured: up to 48 hours after drug administration
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
Measured: up to 24 hours after drug administration in the food-effect part
fet1-t2 (fraction of analyte eliminated in urine compared to oral dose administered from time point t1 to time point t2)
Measured: up to 24 hours after drug administration in the food-effect part
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Measured: up to 24 hours after drug administration in the food-effect part
RCmax,Met (the ratio of Cmax of the metabolite, CD 6168 to Cmax of the parent compound, BI207127)
Measured: up to 48 hours after drug administration
RAUC0-∞,Met (the ratio of AUC0-∞ of the metabolite, CD 6168 to AUC0-∞ of the parent compound, BI207127)
Measured: up to 48 hours after drug administration
AUC0-∞ for CD 6168
Measured: up to 48 hours after drug administration
Cmax for CD 6168
Measured: up to 48 hours after drug administration
Measurement of protein binding in human plasma for BI 207127
Measured: up to 48 hours after drug administration in the food-effect part
Number of patients with adverse events
Measured: up to 9 weeks
Assessment of tolerability on a 4-point scale
Measured: 48 h after each 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 startMay 2009
- Primary completionSep 2009
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
- None (open label)
- Enrolment
- 42 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
- NCT02182414
- Sponsor's protocol ID
- 1241.9
- 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
- Relative Bioavailability of BI 207127 Trial Formulation II Prototypes Versus BI 207127 Trial Formulation I Administered Orally as Tablet in Single Doses of 800 mg to Healthy Volunteers, and Evaluation of the Effect of Food on the Bioavailability of a Selected Prototype (an Open-label, Two-stage, Within Parts Randomised Six-way and Two-way Crossover Phase I Study)
- ClinicalTrials.gov ID
- NCT02182414
- Acronym / sponsor ID
- 1241.9
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Sep 2009 (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.
Study to investigate the relative bioavailability of 5 new 400 mg tablet formulations (trial formulation II prototypes) of BI 207127 compared to the current 200 mg BI 207127 tablet formulation (trial formulation I) in healthy male volunteers with the aim to identify the best formulation for further drug development (formulation finding part / trial part 1) and to investigate the effect of food on the relative bioavailability of the most promising one of these trial formulation II prototypes (food-effect part / trial part 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| BI 207127 NA (TF-I) | Active comparator | Drug: BI 207127 NA (TF-I)trial part 1: 800 mg BI 207127 NA Trial formulation I (TF-I) |
| BI 207127 NA (TF-II) | Experimental | Drug: BI 207127 NA (TF-II)trial part 1: 800 mg BI 207127 NA Trial formulation II (TF-II) |
| BI 207127 NA delayed release | Experimental | Drug: BI 207127 NA delayed releasetrial part 1: 800 mg BI 207127 NA TF-II, delayed release |
| BI 207127 NA extended release (10% HPMC) | Experimental | Drug: BI 207127 NA extended release (10% HPMC)trial part 1: 800 mg BI 207127 NA TF-II, extended release (10% Hydroxypropyl methyl cellulose (HPMC)) |
| BI 207127 NA extended release (15% PEO) | Experimental | Drug: BI 207127 NA extended release (15% PEO)trial part 1: 800 mg BI 207127 NA TF-II, extended release (15% Polyethylene oxide (PEO)) |
| BI 207127 NA extended release (20% HPMC) | Experimental | Drug: BI 207127 NA extended release (20% HPMC)trial part 1: 800 mg BI 207127 NA TF-II, extended release (20% HPMC) |
| BI 207127 (TF-II), fed | Experimental | Drug: BI 207127 NA (TF-II), Drug: BI 207127 NA delayed release, Drug: BI 207127 NA extended release (10% HPMC), Drug: BI 207127 NA extended release (15% PEO), Drug: BI 207127 NA extended release (20% HPMC)trial part 2 |
| BI 207127 (TF-II), fasted | Experimental | Drug: BI 207127 NA (TF-II), Drug: BI 207127 NA delayed release, Drug: BI 207127 NA extended release (10% HPMC), Drug: BI 207127 NA extended release (15% PEO), Drug: BI 207127 NA extended release (20% HPMC)trial part 2 |
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 a complete medical history, including a physical examination,vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
- Age 18 to 50 years, inclusive
- Body mass index 18.5 to 29.9 kg/m2, inclusive
- 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 (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 207127 NA (TF-I)200 mg tablet | Drug | BI 207127 NA (TF-I) |
| BI 207127 NA (TF-II)400 mg tablet | Drug | BI 207127 (TF-II), fasted, BI 207127 (TF-II), fed, BI 207127 NA (TF-II) |
| BI 207127 NA delayed release400 mg tablet | Drug | BI 207127 (TF-II), fasted, BI 207127 (TF-II), fed, BI 207127 NA delayed release |
| BI 207127 NA extended release (10% HPMC)400 mg tablet | Drug | BI 207127 (TF-II), fasted, BI 207127 (TF-II), fed, BI 207127 NA extended release (10% HPMC) |
| BI 207127 NA extended release (15% PEO)400 mg tablet | Drug | BI 207127 (TF-II), fasted, BI 207127 (TF-II), fed, BI 207127 NA extended release (15% PEO) |
| BI 207127 NA extended release (20% HPMC)400 mg tablet | Drug | BI 207127 (TF-II), fasted, BI 207127 (TF-II), fed, BI 207127 NA extended release (20% HPMC) |
Primary outcome
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for BI 207127
Time frame: up to 48 hours after drug administration
Cmax (maximum measured concentration of the analyte in plasma) for BI 207127
Time frame: up to 48 hours after drug administration
18 secondary outcomes
AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval from t1 to t2)
Time frame: up to 24 hours after drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 48 hours after drug administration
λz (terminal rate constant in plasma)
Time frame: up to 48 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 48 hours after drug administration
MRTpo (mean residence time of the analyte in the body after p.o. administration)
Time frame: up to 48 hours after drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: up to 48 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 48 hours after drug administration
The fluctuation parameter Cmax/C12 for the ER (Extended release) formulations only
Time frame: up to 48 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 24 hours after drug administration in the food-effect part
fet1-t2 (fraction of analyte eliminated in urine compared to oral dose administered from time point t1 to time point t2)
Time frame: up to 24 hours after drug administration in the food-effect part
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Time frame: up to 24 hours after drug administration in the food-effect part
RCmax,Met (the ratio of Cmax of the metabolite, CD 6168 to Cmax of the parent compound, BI207127)
Time frame: up to 48 hours after drug administration
RAUC0-∞,Met (the ratio of AUC0-∞ of the metabolite, CD 6168 to AUC0-∞ of the parent compound, BI207127)
Time frame: up to 48 hours after drug administration
AUC0-∞ for CD 6168
Time frame: up to 48 hours after drug administration
Cmax for CD 6168
Time frame: up to 48 hours after drug administration
Measurement of protein binding in human plasma for BI 207127
Time frame: up to 48 hours after drug administration in the food-effect part
Number of patients with adverse events
Time frame: up to 9 weeks
Assessment of tolerability on a 4-point scale
Time frame: 48 h after each 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 (TF-I), BI 207127 NA (TF-II) and BI 207127 NA delayed release 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 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?
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for BI 207127 (time frame: up to 48 hours after drug administration). 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 18 Jul 2014.