HealthyPhase 1NCT02254161
Multiple Rising Dose of BI 1181181 Given Orally in Young Healthy Male and Elderly Healthy Male/Female Volunteers
A Phase 1 study testing BI 1181181 healthy elderly and BI 1181181 Healthy young in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
The primary objective of the current study is to investigate the safety and tolerability of BI 1181181 in healthy young male and elderly male and female volunteers following oral administration of repeated rising doses of BI 1181181, given once daily over 10 days. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 1181181 healthy elderly and BI 1181181 Healthy young
- 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 siteGermany
- Study dates
- Nov 2014to Feb 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests.
- Age of 18 to 50 years (incl.) for young healthy volunteers or of 65 to 80 years (incl.) for elderly healthy volunteers.
- BMI of 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) is deviating from normal and judged as clinically relevant by the investigator
- 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
- Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (except appendectomy)
- Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders
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 1181181 Given Orally q.d. for 10 Days in Young Healthy Male and Elderly Healthy Male/Female Volunteers (Randomized, Double-blind, Placebo Controlled Within Dose Groups Phase I Study)
The primary objective of the current study is to investigate the safety and tolerability of BI 1181181 in healthy young male and elderly male and female volunteers following oral administration of repeated rising doses of BI 1181181, given once daily over 10 days. Secondary objectives are the exploration of the pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1181181.
- Conditions
- Healthy
- Being tested
- Matching placebo, BI 1181181 healthy elderly, BI 1181181 Healthy young
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Matching placeboDrug
Tablet
BI 1181181 healthy elderlyDrug
Tablet
BI 1181181 Healthy youngDrug
Tablet
| Study group | Role | What they receive |
|---|---|---|
| BI 1181181 healthy young | Experimental | Medium doses as tablets q.d. for 10 days Receives: Drug: BI 1181181 Healthy young |
| BI 1181181 healthy elderly | Experimental | Medium doses as tablets q.d. for 10 days Receives: Drug: BI 1181181 healthy elderly |
| Matching placebo in healthy young | Placebo comparator | Matching placebo for 10 days Receives: Drug: Matching placebo |
| Matching placebo in healthy elderly | Placebo comparator | Matching placebo for 10 days Receives: Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency [N (%)] of subjects with drug-related adverse events
Measured: days 1 to 24
Secondary outcomes (6)
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) after administration of the last dose
Measured: 0 to 336 hours
Cmax,ss (maximum measured concentration of the analyte in CSF (if feasible) at steady state over a uniform dosing interval t) after administration of the last dose
Measured: 0 to 336 hours
AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose)
Measured: 0 to 336 hours
Cmax (maximum measured concentration of the analyte in plasma) after administration of the first dose
Measured: 0 to 336 hours
AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) after the administration of the last dose
Measured: 0 to 336 hours
AUCt,ss (area under the concentration-time curve of the analyte in CSF (if feasible) at steady state over a uniform dosing interval t after the administration of the last dose
Measured: 0 to 336 hours
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 startNov 2014
- Primary completionFeb 2015
- Study completionFeb 2015
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
- NCT02254161
- Sponsor's protocol ID
- 1344.2
- Other IDs
- 2014-002482-30, 2014
- Status last verified
- Aug 2018
- First submitted
- 30 Sep 2014
- Last updated
- 31 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. 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 1181181 Given Orally q.d. for 10 Days in Young Healthy Male and Elderly Healthy Male/Female Volunteers (Randomized, Double-blind, Placebo Controlled Within Dose Groups Phase I Study)
- ClinicalTrials.gov ID
- NCT02254161
- Acronym / sponsor ID
- 1344.2
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (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.
The primary objective of the current study is to investigate the safety and tolerability of BI 1181181 in healthy young male and elderly male and female volunteers following oral administration of repeated rising doses of BI 1181181, given once daily over 10 days. Secondary objectives are the exploration of the pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1181181.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BI 1181181 healthy young | Experimental | Drug: BI 1181181 Healthy youngMedium doses as tablets q.d. for 10 days |
| BI 1181181 healthy elderly | Experimental | Drug: BI 1181181 healthy elderlyMedium doses as tablets q.d. for 10 days |
| Matching placebo in healthy young | Placebo comparator | Drug: Matching placeboMatching placebo for 10 days |
| Matching placebo in healthy elderly | Placebo comparator | Drug: Matching placeboMatching placebo for 10 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy male or female subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests.
- Age of 18 to 50 years (incl.) for young healthy volunteers or of 65 to 80 years (incl.) for elderly healthy volunteers.
- BMI of 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 (6 listed)
- Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
- 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
- Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (except appendectomy)
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 |
|---|---|---|
| Matching placeboTablet | Drug | Matching placebo in healthy elderly, Matching placebo in healthy young |
| BI 1181181 healthy elderlyTablet | Drug | BI 1181181 healthy elderly |
| BI 1181181 Healthy youngTablet | Drug | BI 1181181 healthy young |
Primary outcome
frequency [N (%)] of subjects with drug-related adverse events
Time frame: days 1 to 24
6 secondary outcomes
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) after administration of the last dose
Time frame: 0 to 336 hours
Cmax,ss (maximum measured concentration of the analyte in CSF (if feasible) at steady state over a uniform dosing interval t) after administration of the last dose
Time frame: 0 to 336 hours
AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose)
Time frame: 0 to 336 hours
Cmax (maximum measured concentration of the analyte in plasma) after administration of the first dose
Time frame: 0 to 336 hours
AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) after the administration of the last dose
Time frame: 0 to 336 hours
AUCt,ss (area under the concentration-time curve of the analyte in CSF (if feasible) at steady state over a uniform dosing interval t after the administration of the last dose
Time frame: 0 to 336 hours
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 31 Aug 2018.
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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 healthy elderly and BI 1181181 Healthy young 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 6 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 31 Aug 2018. 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 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?
frequency [N (%)] of subjects with drug-related adverse events (time frame: days 1 to 24). 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 31 Aug 2018.