AsthmaPhase 1NCT02126865
Multiple Rising Oral Doses of BI 1060469 in Healthy Subjects and Mild Asthma Patients
A Phase 1 study testing BI 1060469 Healthy and BI 1060469 asthmatics in people with Asthma, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
The primary objective of this trial is to investigate the safety and tolerability of BI 1060469 in healthy male and female subjects after oral administration of repeated rising doses of 3 mg, 10 mg, 25 mg, 75 mg, 150 mg and 250 mg qd. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- BI 1060469 Healthy and BI 1060469 asthmatics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 1 siteGermany
- Study dates
- May 2014to Jul 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy or otherwise healthy asthmatic male or female subjects according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination,vital signs (BP, PR),12-lead ECG, and clinical laboratory tests
- Amended part under fed conditions:
- Healthy female subjects according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (BP, PR),12-lead ECG, and clinical laboratory tests.
- Age 18 to 55 years (incl.)
- BMI 18.5 to 29.9 kg/m2 (incl.)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
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- Male subjects,or females who meet any of the following criteria from at least 30 days before the first study drug administration and until 30 days after trial completion:
- surgically sterilised (including hysterectomy)
- postmenopausal defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory)
- Amended part under fed conditions:
- Female subjects who meet any of the following criteria starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion:
- Use of adequate contraception, e.g. any of the following methods plus condom: implants,injectables,combined oral or vaginal contraceptives,intrauterine device
- Sexually abstinent
- A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)
- Surgically sterilised (including hysterectomy)
- Postmenopausal,defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory) In addition for otherwise healthy asthmatic patients
- Females (of non-child bearing potential) \& males,who have a diagnosis of asthma by a physician at least 3 months prior to screening.The diagnosis of asthma must be according to the 2010 Global Initiative for Asthma (GINA) guidelines
- Pre-bronchodilator clinic measured FEV1 =70% of predicted normal (calculated according to NHANES) measured =6 hours after the last use of short acting bronchodilator at Visit 1 or on the day of randomisation
- Improvement in FEV1 =12% above baseline or an absolute change of at least 200ml within 15-30 minutes after administration of 400 µg salbutamol. Reversibility testing may be repeated twice during the screening period.At minimum reversibility must have been documented within 12 months prior to inclusion.In case airway reversibility cannot be demonstrated subjects may be entered on the basis of a documented valid mannitol challenge test or proven methacholine- or histamine induced airway hyperreactivity according to ATS,which has to be demonstrated within the last 12 months prior to randomisation
- Diagnosis of asthma must have been made before the subject's age of 40.If the subject is =40 years and the diagnosis has not yet been recorded in the subject's medical files, the investigator should assess whether the subject's medical history (e.g. symptoms and prescribed medications) confirms the subject suffered from asthma since before the age of 40.If so,this subject may be considered for inclusion after consultation with the Clinical Monitor Local (CML)
- Subject must have stable asthma not exceeding 8 puffs of salbutamol/day on two consecutive days or 12 puffs/ day between inclusion and randomisation
Who cannot join
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator other than asthma up to GINA treatment step 2 or atopic diseases
- Repeated measurement of systolic blood pressure greater than 140 mm Hg, diastolic blood pressure greater than 90 mm Hg, or pulse rate outside the range of 50 to 90 mmHg
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Serum creatinine laboratory value out of the normal range
- GFR according to CKD-EPI-Formula < 80 ml/ min at screening [R12-1392]
- Current or history of relevant kidney, urinay tract diseases or abnormalities (i.e. nephrolithiasis, hydronephrosis, acute or chronic nephritis, renal injury, renal failure, infections)
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- Any evidence of a concomitant disease judged clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug(s)
- Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders
- History of relevant orthostatic hypotension, fainting spells, or blackouts
- Chronic or relevant acute infections
- History of relevant allergy/hypersensitivity (including allergy to the trial medication or its excipients)
- Intake of drugs with a long half-life (greater than 24 hours) within 30 days or less than 10 half-lives of the respective drug prior to administration of trial medication
- Intake of any NSAIDs, COX2 inhibitors, aspirin, ACE-inhibitors, H2- blockers or OTCor nutripharmaceuticals between screening examination and drug administration
- Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial or that might prolong the QT/QTc interval
- Participation in another trial with investigational drug administration within 60 days prior to administration of trial medication
- Persons who are committed to an institution by way of official or juridical order will not be enrolled in the study.
- Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
- Inability to refrain from smoking on specified trial days
- Alcohol abuse (consumption of more than 20 g/day in females and 30 g/day in males)
- Drug abuse or positive drug screen
- Blood donation (more than 100 mL within 30 days prior to administration of trial medication or intended during the trial)
- Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial
- Inability to comply with dietary regimen of trial site
- At screening, a marked baseline prolongation of QT/QTc interval (such as repeated demonstration of a QTc interval greater than 450 ms) or any other relevant ECG finding
- A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)
- Subject is assessed by the investigator as unsuitable for inclusion, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
- For female subjects:
- Exclusion criterion 29 not applicable for the amended part of the study
- Females who are not surgically sterilised or are not postmenopausal defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory)
- Positive pregnancy test
- Lactation
- In addition for otherwise healthy asthmatic patients:
- Any evidence of a clinically relevant concomitant disease other than asthma or atopic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses of BI 1060469 Tablets in Healthy Subjects and Otherwise Healthy Patients With Asthma up to GINA Treatment Step 2 (Phase I, Randomised, Placebo-controlled, Double-blind Within Dose Groups)
The primary objective of this trial is to investigate the safety and tolerability of BI 1060469 in healthy male and female subjects after oral administration of repeated rising doses of 3 mg, 10 mg, 25 mg, 75 mg, 150 mg and 250 mg qd. of 1 day followed by 14 days and in asthmatic male and female patients after oral administration of repeated rising doses of 25 mg and 150 mg qd of 1 day followed by 28 days.
Secondary objectives are the exploration of the pharmacokinetics (PK) including dose proportionality, dose linearity after single and multiple dose segments, pharmacodynamics (PD) of BI 1060469 and to describe the PK/PD relationship.
- Conditions
- Asthma
- Being tested
- Placebo to BI 1060469, BI 1060469 Healthy, Placebo to BI 1060469 asthmatics, BI 1060469 asthmatics
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo to BI 1060469Drug
tablet
BI 1060469 HealthyDrug
tablet
Placebo to BI 1060469 asthmaticsDrug
tablet
BI 1060469 asthmaticsDrug
tablet
| Study group | Role | What they receive |
|---|---|---|
| BI 1060469 Healthy | Experimental | Multiple rising dose qd for 15 days Receives: Drug: BI 1060469 Healthy |
| Placebo to BI 1060469 | Placebo comparator | Matching placebo as tablet for 15 days Receives: Drug: Placebo to BI 1060469 |
| BI 1060469 asthmatics | Experimental | Multiple rising dose qd for 29 days Receives: Drug: BI 1060469 asthmatics |
| Placebo to BI 1060469 asthmatics | Placebo comparator | Matching placebo as tablet for 29 days Receives: Drug: Placebo to BI 1060469 asthmatics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage (%) of subjects with drug-related adverse events (AEs)
Measured: Day 1 to 29 or Day 1 to Day 43 (end of trial)
Secondary outcomes (7)
AUCt,1 (area under the concentration-time curve of BI 1060469 in plasma over a uniform dosing interval t after administration of the first dose)
Measured: 0 to 672 hours or 0 to 1008 hours
AUC0-infinity (area under the concentration-time curve of BI 1060469 in plasma over the time interval from 0 extrapolated to infinity)
Measured: 0 to 672 hours or 0 to 1008 hours
Cmax (maximum measured concentration of BI 1060469 in plasma)
Measured: 0 to 672 hours or 0 to 1008 hours
AUCt,ss (area under the concentration-time curve of BI 1060469 in plasma at steady state over a uniform dosing interval t)
Measured: 0 to 672 hours or 0 to 1008 hours
Cpre,N (predose concentration of BI 1060469 in plasma immediately before administration of the Nth dose after N-1 doses were administered)
Measured: 0 to 672 hours or 0 to 1008 hours
Cmax,ss (maximum measured concentration of BI 1060469 in plasma at steady state)
Measured: 0 to 672 hours or 0 to 1008 hours
Linearity index (LI)
Measured: 0 to 672 hours or 0 to 1008 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 131 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
- NCT02126865
- Sponsor's protocol ID
- 1333.2
- Other IDs
- 2013-005463-10
- Status last verified
- Aug 2015
- First submitted
- 28 Apr 2014
- Last updated
- 14 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses of BI 1060469 Tablets in Healthy Subjects and Otherwise Healthy Patients With Asthma up to GINA Treatment Step 2 (Phase I, Randomised, Placebo-controlled, Double-blind Within Dose Groups)
- ClinicalTrials.gov ID
- NCT02126865
- Acronym / sponsor ID
- 1333.2
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 30 Apr 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.
The primary objective of this trial is to investigate the safety and tolerability of BI 1060469 in healthy male and female subjects after oral administration of repeated rising doses of 3 mg, 10 mg, 25 mg, 75 mg, 150 mg and 250 mg qd. of 1 day followed by 14 days and in asthmatic male and female patients after oral administration of repeated rising doses of 25 mg and 150 mg qd of 1 day followed by 28 days.
Secondary objectives are the exploration of the pharmacokinetics (PK) including dose proportionality, dose linearity after single and multiple dose segments, pharmacodynamics (PD) of BI 1060469 and to describe the PK/PD relationship.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BI 1060469 Healthy | Experimental | Drug: BI 1060469 HealthyMultiple rising dose qd for 15 days |
| Placebo to BI 1060469 | Placebo comparator | Drug: Placebo to BI 1060469Matching placebo as tablet for 15 days |
| BI 1060469 asthmatics | Experimental | Drug: BI 1060469 asthmaticsMultiple rising dose qd for 29 days |
| Placebo to BI 1060469 asthmatics | Placebo comparator | Drug: Placebo to BI 1060469 asthmaticsMatching placebo as tablet for 29 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- Healthy or otherwise healthy asthmatic male or female subjects according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination,vital signs (BP, PR),12-lead ECG, and clinical laboratory tests
- Healthy female subjects according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (BP, PR),12-lead ECG, and clinical laboratory tests.
- Age 18 to 55 years (incl.)
- BMI 18.5 to 29.9 kg/m2 (incl.)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
Key exclusion criteria (35 listed)
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator other than asthma up to GINA treatment step 2 or atopic diseases
- Repeated measurement of systolic blood pressure greater than 140 mm Hg, diastolic blood pressure greater than 90 mm Hg, or pulse rate outside the range of 50 to 90 mmHg
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Serum creatinine laboratory value out of the normal range
- GFR according to CKD-EPI-Formula < 80 ml/ min at screening [R12-1392]
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 |
|---|---|---|
| Placebo to BI 1060469tablet | Drug | Placebo to BI 1060469 |
| BI 1060469 Healthytablet | Drug | BI 1060469 Healthy |
| Placebo to BI 1060469 asthmaticstablet | Drug | Placebo to BI 1060469 asthmatics |
| BI 1060469 asthmaticstablet | Drug | BI 1060469 asthmatics |
Primary outcome
Percentage (%) of subjects with drug-related adverse events (AEs)
Time frame: Day 1 to 29 or Day 1 to Day 43 (end of trial)
7 secondary outcomes
AUCt,1 (area under the concentration-time curve of BI 1060469 in plasma over a uniform dosing interval t after administration of the first dose)
Time frame: 0 to 672 hours or 0 to 1008 hours
AUC0-infinity (area under the concentration-time curve of BI 1060469 in plasma over the time interval from 0 extrapolated to infinity)
Time frame: 0 to 672 hours or 0 to 1008 hours
Cmax (maximum measured concentration of BI 1060469 in plasma)
Time frame: 0 to 672 hours or 0 to 1008 hours
AUCt,ss (area under the concentration-time curve of BI 1060469 in plasma at steady state over a uniform dosing interval t)
Time frame: 0 to 672 hours or 0 to 1008 hours
Cpre,N (predose concentration of BI 1060469 in plasma immediately before administration of the Nth dose after N-1 doses were administered)
Time frame: 0 to 672 hours or 0 to 1008 hours
Cmax,ss (maximum measured concentration of BI 1060469 in plasma at steady state)
Time frame: 0 to 672 hours or 0 to 1008 hours
Linearity index (LI)
Time frame: 0 to 672 hours or 0 to 1008 hours
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 14 Aug 2015.
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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 1060469 Healthy and BI 1060469 asthmatics in people with Asthma, 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 21 inclusion and 35 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 14 Aug 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. Some participants in this study may receive a placebo. 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?
Percentage (%) of subjects with drug-related adverse events (AEs) (time frame: Day 1 to 29 or Day 1 to Day 43 (end of trial)). 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 14 Aug 2015.