HealthyPhase 1NCT01286571
Bioavailability and Pharmacokinetics of BI 135585 XX Administered as Tablet With and Without Food
A Phase 1 study testing BI 135585 in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
The objective of this study is to investigate the effect of food on the relative bioavailability of a 50 mg BI 135585 XX tablet. 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 135585
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Mar 2011
- 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 conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioavailability and Pharmacokinetics of 50 mg BI 135585 XX Administered as Tablet With and Without Food to Healthy Male Volunteers (an Open-label, Randomised, Single-dose, Two-way Crossover Study)
The objective of this study is to investigate the effect of food on the relative bioavailability of a 50 mg BI 135585 XX tablet.
- Conditions
- Healthy
- Being tested
- BI 135585
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 135585Drug
one oral single dose per subject
BI 135585Drug
one oral single dose per subject
| Study group | Role | What they receive |
|---|---|---|
| BI 135585 (T) | Experimental | single dose per subject as tablet formulation after high fat, high caloric meal Receives: Drug: BI 135585 |
| BI 135585 (R) | Experimental | single dose per subject as tablet formulation after an overnight fast Receives: Drug: BI 135585 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve of BI 135585 in plasma over the time interval from 0 hours extrapolated to infinity
Measured: up to 144 hours post treatment
Maximum measured concentration of the analyte in plasma of BI 135585 in plasma over the time interval from 0 hours extrapolated to infinity
Measured: up to 144 hours post treatment
Secondary outcomes (14)
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 144 hours post treatment
Physical examination (occurrence of findings)
Measured: up to 14 days post treatment
%AUCtz-∞ (percentage of AUC0-∞ obtained by extrapolation)
Measured: up to 144 hours post treatment
tmax (time from dosing to maximum measured concentration)
Measured: up to 144 hours post treatment
λz (terminal rate constant in plasma)
Measured: up to 144 hours post treatment
t1/2 (terminal half-life of the analyte in plasma)
Measured: up to 144 hours post treatment
MRTpo (mean residence time of the analyte in the body after oral administration)
Measured: up to 144 hours post treatment
CL/F (total/apparent clearance of the analyte in plasma after extravascular administration)
Measured: up to 144 hours post treatment
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Measured: up to 144 hours post treatment
Vital signs (blood pressure, pulse rate)
Measured: up to 14 days post treatment
12-lead ECG (electrocardiogram)
Measured: up to 14 days post treatment
Clinical laboratory parameters (haematology, enzymes, substrates, electrolytes, hormones of the HPA axis and the thyroid gland, and urinalysis)
Measured: up to 14 days post treatment
Incidence and severity of Adverse events
Measured: up to 14 days post treatment
Assessment of tolerability by the investigator
Measured: up to 14 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2011
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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286571
- Sponsor's protocol ID
- 1283.3
- Other IDs
- 2010-022697-14
- Status last verified
- Oct 2013
- First submitted
- 28 Jan 2011
- Last updated
- 1 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability and Pharmacokinetics of 50 mg BI 135585 XX Administered as Tablet With and Without Food to Healthy Male Volunteers (an Open-label, Randomised, Single-dose, Two-way Crossover Study)
- ClinicalTrials.gov ID
- NCT01286571
- Acronym / sponsor ID
- 1283.3
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Mar 2011 (actual)
- First posted
- 31 Jan 2011 (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 study is to investigate the effect of food on the relative bioavailability of a 50 mg BI 135585 XX tablet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 135585 (T) | Experimental | Drug: BI 135585single dose per subject as tablet formulation after high fat, high caloric meal |
| BI 135585 (R) | Experimental | Drug: BI 135585single dose per subject as tablet formulation after an overnight fast |
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 conditions
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 135585one oral single dose per subject | Drug | BI 135585 (T) |
| BI 135585one oral single dose per subject | Drug | BI 135585 (R) |
Primary outcome
Area under the concentration-time curve of BI 135585 in plasma over the time interval from 0 hours extrapolated to infinity
Time frame: up to 144 hours post treatment
Maximum measured concentration of the analyte in plasma of BI 135585 in plasma over the time interval from 0 hours extrapolated to infinity
Time frame: up to 144 hours post treatment
14 secondary outcomes
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 144 hours post treatment
Physical examination (occurrence of findings)
Time frame: up to 14 days post treatment
%AUCtz-∞ (percentage of AUC0-∞ obtained by extrapolation)
Time frame: up to 144 hours post treatment
tmax (time from dosing to maximum measured concentration)
Time frame: up to 144 hours post treatment
λz (terminal rate constant in plasma)
Time frame: up to 144 hours post treatment
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 144 hours post treatment
MRTpo (mean residence time of the analyte in the body after oral administration)
Time frame: up to 144 hours post treatment
CL/F (total/apparent clearance of the analyte in plasma after extravascular administration)
Time frame: up to 144 hours post treatment
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 144 hours post treatment
Vital signs (blood pressure, pulse rate)
Time frame: up to 14 days post treatment
12-lead ECG (electrocardiogram)
Time frame: up to 14 days post treatment
Clinical laboratory parameters (haematology, enzymes, substrates, electrolytes, hormones of the HPA axis and the thyroid gland, and urinalysis)
Time frame: up to 14 days post treatment
Incidence and severity of Adverse events
Time frame: up to 14 days post treatment
Assessment of tolerability by the investigator
Time frame: up to 14 days post treatment
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 1 Nov 2013.
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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.
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 135585 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 1 Nov 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 BI 135585 in plasma over the time interval from 0 hours extrapolated to infinity (time frame: up to 144 hours post treatment). 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 1 Nov 2013.