HealthyPhase 1NCT02182401
Multiple Doses of BI 207127 NA, BI 201335 NA Followed by the Combination of BI 207127 NA and BI 201335 NA in Healthy Male Volunteers
A Phase 1 study testing BI 207127 NA, BI 201335 NA and Midazolam in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to investigate the pharmacokinetic drug-drug interaction potential of BI 207127 NA and BI 201335 NA on each other at steady-state and to quantify the effect of BI 207127 NA, and BI 207127 NA combined with BI 201335 NA, on the activity of CYP 2C9 and CYP 3A4 using the probe substrates tolbutamide (CYP 2C9) and… Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 207127 NA, BI 201335 NA and Midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Aug 2009
- 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 21 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males (caucasian)
- Age ranging ≥ 21 and ≤ 50 years
- Body mass index (BMI) ≥ 19 and ≤ 29.9 kg/m2
- Willing to complete all study-related activities
- Volunteers give their written informed consent prior to admission to the study
Who cannot join
- Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, clinically relevant electrolyte disturbances
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of photosensitivity or recurrent rash
- History of orthostatic hypotension, fainting spells or blackouts
- Chronic or clinically relevant acute infections
Show all 22Show fewer
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Intake of drugs with a long half-life (> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
- Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the trial or during the trial
- vulnerable subjects (that is persons kept in detention)
- exclusion of contraindications or hypersensitivity to midazolam and / or tolbutamide
- Participation in another trial with an investigational drug (within two months prior to administration or during the trial)
- Smoker (> 10 cigarettes or > 3 cigars of > 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (> 60 g/day)
- Drug abuse
- Blood donation (> 100 mL within four weeks prior to administration or during the trial)
- Any laboratory value outside the reference range if indicative of underlying disease or poor health
- Excessive physical activities within the last week before the trial or during the trial
- Hypersensitivity to treatment medication and/or related drugs of these classes
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTcF, or QTcB interval >450 ms)
- Homozygous carriers of the UGT1A1 (uridine diphosphate glucuronosyltransferase 1A1) enzyme polymorphism *28 and *60
About this study
Official title: An Open-label, Fixed Sequence Phase I Study in Healthy Male Volunteers to Assess Sequentially the Effects of Multiple Doses of BI 207127 NA, BI 201335 NA Followed by the Combination of BI 207127 NA and BI 201335 NA, on the Single Dose Pharmacokinetics of Midazolam and Tolbutamide and on the Systemic Exposure of BI 207127 NA and BI 201335 NA
Study to investigate the pharmacokinetic drug-drug interaction potential of BI 207127 NA and BI 201335 NA on each other at steady-state and to quantify the effect of BI 207127 NA, and BI 207127 NA combined with BI 201335 NA, on the activity of CYP 2C9 and CYP 3A4 using the probe substrates tolbutamide (CYP 2C9) and midazolam (CYP 3A4).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 207127 NADrug
Days 3-8 and days 25-30
BI 201335 NADrug
Days 15-30
MidazolamDrug
Days 1, 7, 23 and 29
TolbutamideDrug
Days 1, 7, 23 and 29
| Study group | Role | What they receive |
|---|---|---|
| BI 207127 NA | Experimental | fixed sequence Receives: Drug: BI 207127 NA; Drug: BI 201335 NA; Drug: Midazolam; Drug: Tolbutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steady-state Cmax (Maximum measured concentration of the analyte in plasma)
Measured: up to day 31
Steady-state AUC (Area under concentration-time curve)
Measured: up to day 31
Secondary outcomes (16)
Cmax for several time points
Measured: up to day 31
Tmax (Time from dosing to the maximum measured concentration of the analyte in plasma)
Measured: up to day 31
Cx for several time points
Measured: up to day 31
AUC for several time points
Measured: up to day 31
CL/F (Total apparent clearance of the analyte in plasma following extravascular administration) for several time points
Measured: up to day 31
V/F (Apparent volume of distribution during following an extravascular dose) for several time points
Measured: up to day 31
t1/2 (Terminal half-life of the analyte in plasma)
Measured: up to day 31
Cavg0-24
Measured: up to day 31
Ratio for Cmax,Met at several time points
Measured: up to day 31
Ratio for AUC at several time points
Measured: up to day 31
Tlast,N
Measured: up to day 31
Ae (amount of analyte eliminated in urine for different time points)
Measured: up to day 29
CLR (renal clearance of the analyte for different time points)
Measured: up to day 29
fe (fraction of analyte eliminated in urine for different time points)
Measured: up to day 29
Number of patients with adverse events
Measured: up to 66 days
Assessment of tolerability on a 4-pointe scale by investigator
Measured: within 14 days after last drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startJul 2009
- Primary completionAug 2009
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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02182401
- Sponsor's protocol ID
- 1241.18
- Status last verified
- Jul 2014
- First submitted
- 2 Jul 2014
- Last updated
- 18 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Fixed Sequence Phase I Study in Healthy Male Volunteers to Assess Sequentially the Effects of Multiple Doses of BI 207127 NA, BI 201335 NA Followed by the Combination of BI 207127 NA and BI 201335 NA, on the Single Dose Pharmacokinetics of Midazolam and Tolbutamide and on the Systemic Exposure of BI 207127 NA and BI 201335 NA
- ClinicalTrials.gov ID
- NCT02182401
- Acronym / sponsor ID
- 1241.18
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Aug 2009 (actual)
- First posted
- 8 Jul 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.
Study to investigate the pharmacokinetic drug-drug interaction potential of BI 207127 NA and BI 201335 NA on each other at steady-state and to quantify the effect of BI 207127 NA, and BI 207127 NA combined with BI 201335 NA, on the activity of CYP 2C9 and CYP 3A4 using the probe substrates tolbutamide (CYP 2C9) and midazolam (CYP 3A4).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BI 207127 NA | Experimental | Drug: BI 207127 NA, Drug: BI 201335 NA, Drug: Midazolam, Drug: Tolbutamidefixed sequence |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy males (caucasian)
- Age ranging ≥ 21 and ≤ 50 years
- Body mass index (BMI) ≥ 19 and ≤ 29.9 kg/m2
- Willing to complete all study-related activities
- Volunteers give their written informed consent prior to admission to the study
Key exclusion criteria (22 listed)
- Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, clinically relevant electrolyte disturbances
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of photosensitivity or recurrent rash
- History of orthostatic hypotension, fainting spells or blackouts
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 207127 NADays 3-8 and days 25-30 | Drug | BI 207127 NA |
| BI 201335 NADays 15-30 | Drug | BI 207127 NA |
| MidazolamDays 1, 7, 23 and 29 | Drug | BI 207127 NA |
| TolbutamideDays 1, 7, 23 and 29 | Drug | BI 207127 NA |
Primary outcome
Steady-state Cmax (Maximum measured concentration of the analyte in plasma)
Time frame: up to day 31
Steady-state AUC (Area under concentration-time curve)
Time frame: up to day 31
16 secondary outcomes
Cmax for several time points
Time frame: up to day 31
Tmax (Time from dosing to the maximum measured concentration of the analyte in plasma)
Time frame: up to day 31
Cx for several time points
Time frame: up to day 31
AUC for several time points
Time frame: up to day 31
CL/F (Total apparent clearance of the analyte in plasma following extravascular administration) for several time points
Time frame: up to day 31
V/F (Apparent volume of distribution during following an extravascular dose) for several time points
Time frame: up to day 31
t1/2 (Terminal half-life of the analyte in plasma)
Time frame: up to day 31
Cavg0-24
Time frame: up to day 31
Ratio for Cmax,Met at several time points
Time frame: up to day 31
Ratio for AUC at several time points
Time frame: up to day 31
Tlast,N
Time frame: up to day 31
Ae (amount of analyte eliminated in urine for different time points)
Time frame: up to day 29
CLR (renal clearance of the analyte for different time points)
Time frame: up to day 29
fe (fraction of analyte eliminated in urine for different time points)
Time frame: up to day 29
Number of patients with adverse events
Time frame: up to 66 days
Assessment of tolerability on a 4-pointe scale by investigator
Time frame: within 14 days after last drug administration
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 207127 NA, BI 201335 NA and Midazolam in people with Healthy, run by Boehringer Ingelheim.
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 5 inclusion and 22 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: stopped early, as of the sponsor's last update on 18 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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 stopped early. Results are not available in the source record.
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?
Steady-state Cmax (Maximum measured concentration of the analyte in plasma) (time frame: up to day 31). 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 18 Jul 2014.