HealthyPhase 1NCT01897597
Clinical Drug Trial in Healthy Male Subjects to Determine and Compare the Blood Concentrations of BI 144807 Following Administration as Oral Solution and Tablet Under Fasted and Fed Conditions
A Phase 1 study testing BI 144807 high dose and BI 144807 intermediate dose in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
The purpose of this trial is to investigate the relative bioavailability of a BI 144807 tablet formulation compared to the oral solution formulation after single dose administration (intermediate and high dose) under fasted conditions. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 144807 high dose and BI 144807 intermediate dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2013to Sep 2013
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects
Who cannot join
- Any relevant deviation from healthy condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single Dose, Randomised, Crossover Trial in Healthy Male Subjects to Investigate the Relative Bioavailability of Tablet and Oral Solution of Two Doses of BI 144807 and Relative Bioavailability of BI 144807 When Administered as Tablet Under Fed and Fasted Conditions
The purpose of this trial is to investigate the relative bioavailability of a BI 144807 tablet formulation compared to the oral solution formulation after single dose administration (intermediate and high dose) under fasted conditions. Further objectives are to assess whether and to what extent food affects single dose pharmacokinetics of BI 144807 administered as tablet, and to compare the relative bioavailability of two different tablet formulations.
- Conditions
- Healthy
- Being tested
- BI 144807 high dose, BI 144807 intermediate dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 144807 high doseDrug
oral solution
BI 144807 intermediate doseDrug
tablet
BI 144807 intermediate doseDrug
tablet
BI 144807 intermediate doseDrug
tablet
BI 144807 intermediate doseDrug
tablet
BI 144807 intermediate doseDrug
oral solution
BI 144807 high doseDrug
tablet
| Study group | Role | What they receive |
|---|---|---|
| BI 144807 PfoS Treatment A | Experimental | intermediate dose of BI 144807 Receives: Drug: BI 144807 intermediate dose |
| BI 144807 PfoS Treatment C | Experimental | high dose of BI 144807 Receives: Drug: BI 144807 high dose |
| BI 144807 Tab Treatment B | Experimental | intermediate dose of BI 144807 Receives: Drug: BI 144807 intermediate dose |
| BI 144807 Tab Treatment D | Experimental | high dose of BI 144807 Receives: Drug: BI 144807 high dose |
| BI 144807 Tab Treatment E | Experimental | intermediate dose of BI 144807, fasted Receives: Drug: BI 144807 intermediate dose |
| BI 144807 Tab Treatment F | Experimental | intermediate dose of BI 144807, fed Receives: Drug: BI 144807 intermediate dose |
| BI 144807 Tab Treatment G | Experimental | intermediate dose of BI 144807, fasted Receives: Drug: BI 144807 intermediate dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Measured: 48 hours
Maximum measured concentration of the analyte in plasma (Cmax)
Measured: 48 hours
Secondary outcomes (1)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2013
- Study completionSep 2013
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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01897597
- Sponsor's protocol ID
- 1313.9
- Other IDs
- 2013-000258-23
- Status last verified
- Sep 2013
- First submitted
- 9 Jul 2013
- Last updated
- 6 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single Dose, Randomised, Crossover Trial in Healthy Male Subjects to Investigate the Relative Bioavailability of Tablet and Oral Solution of Two Doses of BI 144807 and Relative Bioavailability of BI 144807 When Administered as Tablet Under Fed and Fasted Conditions
- ClinicalTrials.gov ID
- NCT01897597
- Acronym / sponsor ID
- 1313.9
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 12 Jul 2013 (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 purpose of this trial is to investigate the relative bioavailability of a BI 144807 tablet formulation compared to the oral solution formulation after single dose administration (intermediate and high dose) under fasted conditions. Further objectives are to assess whether and to what extent food affects single dose pharmacokinetics of BI 144807 administered as tablet, and to compare the relative bioavailability of two different tablet formulations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| BI 144807 PfoS Treatment A | Experimental | Drug: BI 144807 intermediate doseintermediate dose of BI 144807 |
| BI 144807 PfoS Treatment C | Experimental | Drug: BI 144807 high dosehigh dose of BI 144807 |
| BI 144807 Tab Treatment B | Experimental | Drug: BI 144807 intermediate doseintermediate dose of BI 144807 |
| BI 144807 Tab Treatment D | Experimental | Drug: BI 144807 high dosehigh dose of BI 144807 |
| BI 144807 Tab Treatment E | Experimental | Drug: BI 144807 intermediate doseintermediate dose of BI 144807, fasted |
| BI 144807 Tab Treatment F | Experimental | Drug: BI 144807 intermediate doseintermediate dose of BI 144807, fed |
| BI 144807 Tab Treatment G | Experimental | Drug: BI 144807 intermediate doseintermediate dose of BI 144807, fasted |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male subjects
Key exclusion criteria (1 listed)
- Any relevant deviation from healthy condition
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 144807 high doseoral solution | Drug | BI 144807 PfoS Treatment C |
| BI 144807 intermediate dosetablet | Drug | BI 144807 Tab Treatment F |
| BI 144807 intermediate dosetablet | Drug | BI 144807 Tab Treatment E |
| BI 144807 intermediate dosetablet | Drug | BI 144807 Tab Treatment G |
| BI 144807 intermediate dosetablet | Drug | BI 144807 Tab Treatment B |
| BI 144807 intermediate doseoral solution | Drug | BI 144807 PfoS Treatment A |
| BI 144807 high dosetablet | Drug | BI 144807 Tab Treatment D |
Primary outcome
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Time frame: 48 hours
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: 48 hours
1 secondary outcome
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)
Time frame: 48 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 6 Sep 2013.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 144807 high dose and BI 144807 intermediate dose in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
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 1 inclusion and 1 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 6 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) (time frame: 48 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 6 Sep 2013.