HealthyPhase 1NCT02254148
The Effect of BI 187004 on the Pharmacokinetics of Cytochrome P450 Substrates (Caffeine, Warfarin, Omeprazole, Metoprolol and Midazolam) and a P Glycoprotein Substrate (Digoxin)
A Phase 1 study testing midazolam, caffeine and digoxin in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
To assess the influence of BI 187004 on kinetics of cytochrome P450 (CYP) and P glycoprotein (P-gp) probe drugs as a means of predicting drug-drug interactions. 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?
- midazolam, caffeine and digoxin
- 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 2014to Dec 2014
- 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
- age of 18 to 55 years
- body mass index of 18.5 to 29.9 kg/m2
- Subjects must be able to understand and comply with study requirements
Who cannot join
- Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
- Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease judged as clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)
- Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Multiple Doses of BI 187004 on the Single Dose Pharmacokinetics of Cytochrome P450 Substrates (Caffeine, Warfarin, Omeprazole, Metoprolol and Midazolam) and a P-glycoprotein Substrate (Digoxin) Administered Orally in an Open-label, One-sequence Trial in Healthy Subjects
To assess the influence of BI 187004 on kinetics of cytochrome P450 (CYP) and P glycoprotein (P-gp) probe drugs as a means of predicting drug-drug interactions.
- Conditions
- Healthy
- Being tested
- midazolam, caffeine, digoxin, warfarin, omeprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
midazolamDrug
single dose of midazolam given as oral solution (day 1 of visits 2 and 3)
caffeineDrug
single dose of caffeine given as tablets (day 1 of visits 2 and 3)
digoxinDrug
single dose of digoxin given as tablets (day 3 of visits 2 and 3)
warfarinDrug
single dose of warfarin given as tablets (day 1 of visits 2 and 3)
omeprazoleDrug
single dose of omeprazole given as tablet (day 1 of visits 2 and 3)
BI 187004Drug
multiple doses of BI 187004 given as tablets (day 7-12 of visit 2 and day 1-6 of visit 3)
metoprololDrug
single dose of metoprolol given as tablets (day 1 of visits 2 and 3)
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | single dose of CYP 450 substrates and a P-gp substrate + multiple doses of BI 187004 Receives: Drug: midazolam; Drug: caffeine; Drug: digoxin; Drug: warfarin; Drug: omeprazole; Drug: BI 187004; Drug: metoprolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) for probe substrates
Measured: up to 143 hours postdose
Cmax (Maximum measured concentration of the analyte in plasma) for probe substrates
Measured: up to 143 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2014
- Study completionDec 2014
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
- Not applicable
- 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
- NCT02254148
- Sponsor's protocol ID
- 1307.19
- Other IDs
- 2013-005029-22
- Status last verified
- Dec 2014
- First submitted
- 30 Sep 2014
- Last updated
- 23 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Multiple Doses of BI 187004 on the Single Dose Pharmacokinetics of Cytochrome P450 Substrates (Caffeine, Warfarin, Omeprazole, Metoprolol and Midazolam) and a P-glycoprotein Substrate (Digoxin) Administered Orally in an Open-label, One-sequence Trial in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02254148
- Acronym / sponsor ID
- 1307.19
- 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 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 1 Oct 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.
To assess the influence of BI 187004 on kinetics of cytochrome P450 (CYP) and P glycoprotein (P-gp) probe drugs as a means of predicting drug-drug interactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: midazolam, Drug: caffeine, Drug: digoxin, Drug: warfarin, Drug: omeprazole, Drug: BI 187004, Drug: metoprololsingle dose of CYP 450 substrates and a P-gp substrate + multiple doses of BI 187004 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy male subjects
- age of 18 to 55 years
- body mass index of 18.5 to 29.9 kg/m2
- Subjects must be able to understand and comply with study requirements
Key exclusion criteria (7 listed)
- Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
- Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease judged as clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal 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 |
|---|---|---|
| midazolamsingle dose of midazolam given as oral solution (day 1 of visits 2 and 3) | Drug | Treatment |
| caffeinesingle dose of caffeine given as tablets (day 1 of visits 2 and 3) | Drug | Treatment |
| digoxinsingle dose of digoxin given as tablets (day 3 of visits 2 and 3) | Drug | Treatment |
| warfarinsingle dose of warfarin given as tablets (day 1 of visits 2 and 3) | Drug | Treatment |
| omeprazolesingle dose of omeprazole given as tablet (day 1 of visits 2 and 3) | Drug | Treatment |
| BI 187004multiple doses of BI 187004 given as tablets (day 7-12 of visit 2 and day 1-6 of visit 3) | Drug | Treatment |
| metoprololsingle dose of metoprolol given as tablets (day 1 of visits 2 and 3) | Drug | Treatment |
Primary outcome
AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) for probe substrates
Time frame: up to 143 hours postdose
Cmax (Maximum measured concentration of the analyte in plasma) for probe substrates
Time frame: up to 143 hours postdose
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 23 Dec 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.
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 midazolam, caffeine and digoxin 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 4 inclusion and 7 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 23 Dec 2014. 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-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) for probe substrates (time frame: up to 143 hours postdose). 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 23 Dec 2014.