HealthyPhase 1NCT01707940
Bioavailability of BI 144807 Given Alone and in Combination With Ketoconazole in Healthy Male Volunteers
A Phase 1 study testing Ketoconazole and BI 144807 in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
This trial investigates the influence of oral ketoconazole on the pharmacokinetics and safety of BI 144807. 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?
- Ketoconazole and BI 144807
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2012to Dec 2012
- 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
- 1. healthy male subjects
Who cannot join
- 1. any relevant deviation from healthy conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relative Bioavailability of a Single Oral Dose of BI 144807 (Oral Solution) When Administered Alone or in Combination With Multiple Oral Doses of Ketoconazole (200 mg Tablet) in Healthy Male Subjects (an Open-label, Two-period, Fixed-sequence Trial)
This trial investigates the influence of oral ketoconazole on the pharmacokinetics and safety of BI 144807.
- Conditions
- Healthy
- Being tested
- Ketoconazole, BI 144807
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetoconazoleDrug
Ketoconazole 400 mg / day
BI 144807Drug
BI144807 oral solution, intermediate dose
BI 144807Drug
BI144807 oral solution, intermediate dose
| Study group | Role | What they receive |
|---|---|---|
| BI 144807 | Experimental | subjects receive an oral single dose of BI 144807 Receives: Drug: BI 144807 |
| BI 144807 plus Ketoconazole | Experimental | subjects receive bid ketoconazole plus an oral single dose of BI 144807 Receives: Drug: Ketoconazole; Drug: BI 144807 |
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 extrapolated to infinity
Measured: 0 to 48 hours after administration
Maximum measured concentration of the analyte in plasma
Measured: 0 to 48 hours after administration
Secondary outcomes (1)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point
Measured: 0 to 48 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2012
- Study completionDec 2012
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
- 24 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
- NCT01707940
- Sponsor's protocol ID
- 1313.7
- Other IDs
- 2012-003225-21
- Status last verified
- May 2013
- First submitted
- 15 Oct 2012
- Last updated
- 16 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 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 144807 (Oral Solution) When Administered Alone or in Combination With Multiple Oral Doses of Ketoconazole (200 mg Tablet) in Healthy Male Subjects (an Open-label, Two-period, Fixed-sequence Trial)
- ClinicalTrials.gov ID
- NCT01707940
- Acronym / sponsor ID
- 1313.7
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 Oct 2012 (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.
This trial investigates the influence of oral ketoconazole on the pharmacokinetics and safety of BI 144807.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 144807 | Experimental | Drug: BI 144807subjects receive an oral single dose of BI 144807 |
| BI 144807 plus Ketoconazole | Experimental | Drug: Ketoconazole, Drug: BI 144807subjects receive bid ketoconazole plus an oral single dose of BI 144807 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. healthy male subjects
Key exclusion criteria (1 listed)
- 1. 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 |
|---|---|---|
| KetoconazoleKetoconazole 400 mg / day | Drug | BI 144807 plus Ketoconazole |
| BI 144807BI144807 oral solution, intermediate dose | Drug | BI 144807 |
| BI 144807BI144807 oral solution, intermediate dose | Drug | BI 144807 plus Ketoconazole |
Primary outcome
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity
Time frame: 0 to 48 hours after administration
Maximum measured concentration of the analyte in plasma
Time frame: 0 to 48 hours after administration
1 secondary outcome
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point
Time frame: 0 to 48 hours after 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 16 May 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 Ketoconazole and BI 144807 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 16 May 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 extrapolated to infinity (time frame: 0 to 48 hours after 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 16 May 2013.