HealthyPhase 1NCT01189175
Study in Healthy Male Subjects to Investigate Whether Ketoconazole Affects Plasma Exposure of BI 113823
A Phase 1 study testing BI 113823 + Ketokonazole and BI 113823 in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
The objective of the study is to investigate whether ketoconazole affects plasma exposure of BI 113823 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 113823 + Ketokonazole and BI 113823
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2010to Sep 2010
- 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 male subjects
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relative Bioavailability of a Single Oral Dose of BI 113823 (50 mg qd) When Administered Alone or in Combination With Multiple Oral Doses of Ketoconazole (200 mg Bid) in Healthy Male Volunteers (an Open Label, Two Periods, Fixed-sequence, Clinical Phase I Study)
The objective of the study is to investigate whether ketoconazole affects plasma exposure of BI 113823
- Conditions
- Healthy
- Being tested
- BI 113823 + Ketokonazole, BI 113823
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 113823 + KetokonazoleDrug
5 days ketokonazole with single oral dose of BI 113823 on day 3
BI 113823Drug
single oral dose
| Study group | Role | What they receive |
|---|---|---|
| BI 113823 | Experimental | single oral dose per subject Receives: Drug: BI 113823 |
| BI 113823 + Ketokonazole | Experimental | after wash-out 5 days ketokonazole with BI 113823 on day 3 Receives: Drug: BI 113823 + Ketokonazole |
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) of BI 113823
Measured: 2 weeks
Cmax (maximum measured concentration of the analyte in plasma) of BI 113823
Measured: 2 weeks
Secondary outcomes (18)
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: 2 weeks
Number of participants with clinically significant changes in physical examination
Measured: up to 24 days
Number of participants with clinically significant changes in vital signs
Measured: up to 24 days
Number of participants with clinically significant changes in ECG
Measured: up to 24 days
Number of participants with clinically significant changes in laboratory tests
Measured: up to 24 days
Occurrence of adverse events
Measured: up to 24 days
Assessment of tolerability by the investigator
Measured: up to 24 days
AUCt1-t2 (Area under the concentration time curve of the analyte in plasma over the time interval t1 to t2)
Measured: 2 weeks
AUC0-tmax (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to median tmax
Measured: 2 weeks
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Measured: 2 weeks
λz (terminal rate constant in plasma) t1/2 (terminal half-life of the analyte in plasma
Measured: 2 weeks
t1/2 (terminal half-life of the analyte in plasma)
Measured: 2 weeks
MRTpo (mean residence time of the analyte in the body after po administration)
Measured: 2 weeks
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Measured: 2 weeks
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Measured: 2 weeks
Ae0-24 (amount of analyte that is eliminated in urine from the time interval 0 to 24)
Measured: visit 2, day 1 and visit 4 day 1
fe0-24 (fraction of administered drug excreted unchanged in urine from time point 0 to 24
Measured: visit 2, day 1 and visit 4 day 1
CLR,0-24 (renal clearance of the analyte in plasma from the time point 0 until the time point 24)
Measured: visit 2, day 1 and visit 4 day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionSep 2010
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT01189175
- Sponsor's protocol ID
- 1272.5
- Other IDs
- 2010-018542-31
- Status last verified
- Oct 2013
- First submitted
- 25 Aug 2010
- 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
- Relative Bioavailability of a Single Oral Dose of BI 113823 (50 mg qd) When Administered Alone or in Combination With Multiple Oral Doses of Ketoconazole (200 mg Bid) in Healthy Male Volunteers (an Open Label, Two Periods, Fixed-sequence, Clinical Phase I Study)
- ClinicalTrials.gov ID
- NCT01189175
- Acronym / sponsor ID
- 1272.5
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Sep 2010 (actual)
- First posted
- 26 Aug 2010 (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 the study is to investigate whether ketoconazole affects plasma exposure of BI 113823
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 113823 | Experimental | Drug: BI 113823single oral dose per subject |
| BI 113823 + Ketokonazole | Experimental | Drug: BI 113823 + Ketokonazoleafter wash-out 5 days ketokonazole with BI 113823 on day 3 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy male subjects
Key exclusion criteria (0 listed)
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 113823 + Ketokonazole5 days ketokonazole with single oral dose of BI 113823 on day 3 | Drug | BI 113823 + Ketokonazole |
| BI 113823single oral dose | Drug | BI 113823 |
Primary outcome
AUC0-∞(area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) of BI 113823
Time frame: 2 weeks
Cmax (maximum measured concentration of the analyte in plasma) of BI 113823
Time frame: 2 weeks
18 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: 2 weeks
Number of participants with clinically significant changes in physical examination
Time frame: up to 24 days
Number of participants with clinically significant changes in vital signs
Time frame: up to 24 days
Number of participants with clinically significant changes in ECG
Time frame: up to 24 days
Number of participants with clinically significant changes in laboratory tests
Time frame: up to 24 days
Occurrence of adverse events
Time frame: up to 24 days
Assessment of tolerability by the investigator
Time frame: up to 24 days
AUCt1-t2 (Area under the concentration time curve of the analyte in plasma over the time interval t1 to t2)
Time frame: 2 weeks
AUC0-tmax (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to median tmax
Time frame: 2 weeks
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: 2 weeks
λz (terminal rate constant in plasma) t1/2 (terminal half-life of the analyte in plasma
Time frame: 2 weeks
t1/2 (terminal half-life of the analyte in plasma)
Time frame: 2 weeks
MRTpo (mean residence time of the analyte in the body after po administration)
Time frame: 2 weeks
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: 2 weeks
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: 2 weeks
Ae0-24 (amount of analyte that is eliminated in urine from the time interval 0 to 24)
Time frame: visit 2, day 1 and visit 4 day 1
fe0-24 (fraction of administered drug excreted unchanged in urine from time point 0 to 24
Time frame: visit 2, day 1 and visit 4 day 1
CLR,0-24 (renal clearance of the analyte in plasma from the time point 0 until the time point 24)
Time frame: visit 2, day 1 and visit 4 day 1
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 113823 + Ketokonazole and BI 113823 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 0 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?
AUC0-∞(area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) of BI 113823 (time frame: 2 weeks). 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.