HealthyPhase 1NCT02345304
Effect of BI 1181181 on Midazolam, Warfarin, Omeprazole and Digoxin
A Phase 1 study testing Omeprazole, Warfarin and BI 1181181 in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
To assess the influence of different dose strengths of BI 1181181 on single dose kinetics of midazolam (CYP3A4 probe drug), warfarin (CYP2C9 probe drug), omeprazole (CYP2C19 probe drug) and digoxin (P-gp probe drug) 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?
- Omeprazole, Warfarin and BI 1181181
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2015to May 2015
- 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
- age of 18 to 50 years
- body mass index (BMI) 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 at screening
- 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 the 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: A Study to Investigate the Effects of BI 1181181 on the Pharmacokinetics of Midazolam, Warfarin, Omeprazole and Digoxin in Healthy Male Subjects
To assess the influence of different dose strengths of BI 1181181 on single dose kinetics of midazolam (CYP3A4 probe drug), warfarin (CYP2C9 probe drug), omeprazole (CYP2C19 probe drug) and digoxin (P-gp probe drug)
- Conditions
- Healthy
- Being tested
- Omeprazole, Warfarin, BI 1181181, Midazolam, Digoxin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmeprazoleDrug
WarfarinDrug
BI 1181181Drug
MidazolamDrug
OmeprazoleDrug
BI 1181181Drug
MidazolamDrug
MidazolamDrug
WarfarinDrug
BI 1181181Drug
DigoxinDrug
DigoxinDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment 3 | Experimental | single dose of midazolam + BI drug Receives: Drug: Midazolam; Drug: BI 1181181 |
| Treatment 4 | Experimental | single dose of probe drugs + BI drug Receives: Drug: Omeprazole; Drug: Midazolam; Drug: BI 1181181; Drug: Warfarin |
| Treatment 5 | Experimental | single dose of digoxin + BI drug Receives: Drug: BI 1181181; Drug: Digoxin |
| Treatment 1 | Experimental | single doses of probe drugs Receives: Drug: Warfarin; Drug: Omeprazole; Drug: Midazolam |
| Treatment 2 | Experimental | single dose of digoxin Receives: Drug: Digoxin |
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) of midazolam and omeprazol after each dosing
Measured: up to 24 hours
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) of digoxin after each dosing
Measured: up to 96 hours
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) of warfarin after each dosing
Measured: up to 120 hours
Cmax (Maximum measured concentration the analyte in plasma) of midazolam and omeprazol after each dosing
Measured: up to 24 hours
Cmax (Maximum measured concentration the analyte in plasma) of digoxin after each dosing
Measured: up to 96 hours
Cmax (Maximum measured concentration the analyte in plasma) of warfarin after each dosing
Measured: up to 120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startMar 2015
- Primary completionApr 2015 (estimated)
- Study completionMay 2015 (estimated)
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT02345304
- Sponsor's protocol ID
- 1344.3
- Other IDs
- 2014-004329-42, 2014
- Status last verified
- Mar 2015
- First submitted
- 20 Jan 2015
- Last updated
- 10 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Effects of BI 1181181 on the Pharmacokinetics of Midazolam, Warfarin, Omeprazole and Digoxin in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02345304
- Acronym / sponsor ID
- 1344.3
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Apr 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 26 Jan 2015 (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 different dose strengths of BI 1181181 on single dose kinetics of midazolam (CYP3A4 probe drug), warfarin (CYP2C9 probe drug), omeprazole (CYP2C19 probe drug) and digoxin (P-gp probe drug)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment 3 | Experimental | Drug: Midazolam, Drug: BI 1181181single dose of midazolam + BI drug |
| Treatment 4 | Experimental | Drug: Omeprazole, Drug: Midazolam, Drug: BI 1181181, Drug: Warfarinsingle dose of probe drugs + BI drug |
| Treatment 5 | Experimental | Drug: BI 1181181, Drug: Digoxinsingle dose of digoxin + BI drug |
| Treatment 1 | Experimental | Drug: Warfarin, Drug: Omeprazole, Drug: Midazolamsingle doses of probe drugs |
| Treatment 2 | Experimental | Drug: Digoxinsingle dose of digoxin |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy male subjects
- age of 18 to 50 years
- body mass index (BMI) 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 at screening
- 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 |
|---|---|---|
| Omeprazole | Drug | Treatment 4 |
| Warfarin | Drug | Treatment 1 |
| BI 1181181 | Drug | Treatment 5 |
| Midazolam | Drug | Treatment 4 |
| Omeprazole | Drug | Treatment 1 |
| BI 1181181 | Drug | Treatment 4 |
| Midazolam | Drug | Treatment 3 |
| Midazolam | Drug | Treatment 1 |
| Warfarin | Drug | Treatment 4 |
| BI 1181181 | Drug | Treatment 3 |
| Digoxin | Drug | Treatment 5 |
| Digoxin | Drug | Treatment 2 |
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) of midazolam and omeprazol after each dosing
Time frame: up to 24 hours
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) of digoxin after each dosing
Time frame: up to 96 hours
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) of warfarin after each dosing
Time frame: up to 120 hours
Cmax (Maximum measured concentration the analyte in plasma) of midazolam and omeprazol after each dosing
Time frame: up to 24 hours
Cmax (Maximum measured concentration the analyte in plasma) of digoxin after each dosing
Time frame: up to 96 hours
Cmax (Maximum measured concentration the analyte in plasma) of warfarin after each dosing
Time frame: up to 120 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
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 Omeprazole, Warfarin and BI 1181181 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: withdrawn, as of the sponsor's last update on 10 Mar 2015. 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 was withdrawn before enrolling participants, so there are no results.
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) of midazolam and omeprazol after each dosing (time frame: up to 24 hours). The study lists 6 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 10 Mar 2015.