HealthyPhase 1NCT02106247
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of BI 1181181 in Healthy Male Volunteers
A Phase 1 study testing BI 1181181 high dose and BI 1181181 low dose in people with Healthy, run by Boehringer Ingelheim at 1 site in Belgium.
Trial summary
To assess the reduction of ß-amyloid levels in cerebrospinal fluid and plasma and to evaluate pharmacokinetics, safety and tolerability following single oral doses of BI 1181181. 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?
- BI 1181181 high dose and BI 1181181 low dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2014to Jun 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males 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 50 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
Who cannot join
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator
- Repeated measurement of systolic blood pressure < 90 mmHg and >= 140 mmHg at screening in supine position
- Repeated measurement of diastolic blood pressure < 55 and >= 90 mmHg at screening in supine position
- Repeated measurement of pulse rate < 40 bpm and > 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 clinically relevant by the investigator
Show all 32Show fewer
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract that could interfere with kinetics of the trial drug
- 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
- Positive testing on infectious diseases
- History of relevant allergy/hypersensitivity (including allergy to the trial medication or its excipients)
- Intake of drugs with a long half-life (>24 hours) within 30 days or less than 10 halflives of the respective drug prior to administration of trial medication
- Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial
- Participation in another trial with investigational drug administration within 60 days prior to administration of trial medication
- Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (consumption of more than 40 g per day)
- Drug abuse
- Positive testing in the alcohol breath test or the drug screening test
- Blood donation (more than 100 mL within 30 days prior to administration of trial medication or 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 QTcF interval >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)
- Abnormal parameters for thyroid hormones (T3, T4, TSH), coagulation parameters (partial thromboplastin time (aPTT), prothrombin time (PT) and fibrinogen (retests prior inclusion are allowed))
- 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
- Male subjects who do not agree to minimize the risk of female partners becoming pregnant from the first dosing day until two month after the trial completion. Acceptable methods of contraception comprise barrier contraception and a medically accepted contraceptive method for the female partner (intra-uterine device with spermicide, hormonal contraceptive for at least two month prior trial participation)
- History of retinopathy
- Any history or present disease of the central nervous system, the spinal cord or the spinal column, which could provoke complications with procedure of the lumbar catheterization/intrathecal punction
- Signs of intracranial overpressure as determined by funduscopy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of BI 1181181 in Young Healthy Male Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups Phase I Trial)
To assess the reduction of ß-amyloid levels in cerebrospinal fluid and plasma and to evaluate pharmacokinetics, safety and tolerability following single oral doses of BI 1181181.
- Conditions
- Healthy
- Being tested
- BI 1181181 high dose, BI 1181181 low dose, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 1181181 high doseDrug
two tablet
BI 1181181 low doseDrug
one tablet
PlaceboDrug
tablet
| Study group | Role | What they receive |
|---|---|---|
| 1 BI 1181181 low dose | Experimental | tablet Receives: Drug: BI 1181181 low dose |
| BI 1181181 high dose | Experimental | tablet Receives: Drug: BI 1181181 high dose |
| Placebo | Experimental | tablet Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
%-change from baseline of Aß1-40 in cerebrospinal fluid at the end of the dosing interval (i.e., 24 hrs post dose) (PoM)
Measured: up to 24 h
Secondary outcomes (3)
AUC0-tz (area under the concentration-time curve of the analyte in plasma and cerebrospinal fluid over the time interval from 0 to the last quantifiable data point)
Measured: up to 72 h
Cmax (maximum measured concentration of the analyte in plasma and cerebrospinal fluid)
Measured: up to 72 h
AUC0-infinity (area under the concentration-time curve of the analyte in plasma and cerebrospinal fluid (if possible) over the time interval from 0 extrapolated to infinity)
Measured: up to 72 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2014
- Study completionJun 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
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 36 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
- NCT02106247
- Sponsor's protocol ID
- 1344.20
- Other IDs
- 2013-004563-32
- Status last verified
- Jul 2014
- First submitted
- 1 Apr 2014
- Last updated
- 10 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of BI 1181181 in Young Healthy Male Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups Phase I Trial)
- ClinicalTrials.gov ID
- NCT02106247
- Acronym / sponsor ID
- 1344.20
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 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.
To assess the reduction of ß-amyloid levels in cerebrospinal fluid and plasma and to evaluate pharmacokinetics, safety and tolerability following single oral doses of BI 1181181.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 BI 1181181 low dose | Experimental | Drug: BI 1181181 low dosetablet |
| BI 1181181 high dose | Experimental | Drug: BI 1181181 high dosetablet |
| Placebo | Experimental | Drug: Placebotablet |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males 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 50 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 (32 listed)
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator
- Repeated measurement of systolic blood pressure < 90 mmHg and >= 140 mmHg at screening in supine position
- Repeated measurement of diastolic blood pressure < 55 and >= 90 mmHg at screening in supine position
- Repeated measurement of pulse rate < 40 bpm and > 90 bpm at screening
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
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 1181181 high dosetwo tablet | Drug | BI 1181181 high dose |
| BI 1181181 low doseone tablet | Drug | 1 BI 1181181 low dose |
| Placebotablet | Drug | Placebo |
Primary outcome
%-change from baseline of Aß1-40 in cerebrospinal fluid at the end of the dosing interval (i.e., 24 hrs post dose) (PoM)
Time frame: up to 24 h
3 secondary outcomes
AUC0-tz (area under the concentration-time curve of the analyte in plasma and cerebrospinal fluid over the time interval from 0 to the last quantifiable data point)
Time frame: up to 72 h
Cmax (maximum measured concentration of the analyte in plasma and cerebrospinal fluid)
Time frame: up to 72 h
AUC0-infinity (area under the concentration-time curve of the analyte in plasma and cerebrospinal fluid (if possible) over the time interval from 0 extrapolated to infinity)
Time frame: up to 72 h
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 10 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.
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 1181181 high dose and BI 1181181 low dose in people with Healthy, run by Boehringer Ingelheim at 1 site in Belgium.
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 32 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 10 Jul 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 Belgium. 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?
%-change from baseline of Aß1-40 in cerebrospinal fluid at the end of the dosing interval (i.e., 24 hrs post dose) (PoM) (time frame: up to 24 h). 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 Jul 2014.