HealthyPhase 1NCT02148107
Multiple Rising Oral Doses of BI 691751 in Healthy Male Subjects
A Phase 1 study testing BI 691751 in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
It is the objective of this MRD trial to investigate pharmacokinetics, pharmcodynamics, safety and tolerability of rising doses BI 691751 over a treatment period of 14 days to support the further clinical development of this LTA4H-inhibitor. 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 691751
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- May 2014to Aug 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 according to the investigator´s assessment, based on a complete medical history including a physical examination, vital signs (BP (blood pressure), PR (pulse rate), 12-lead ECG (electro cardiogramm), and clinical laboratory tests
- Age of 18 to 50 years (incl.)
- BMI (body mass index) 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(Good Clinical Practice) and local legislation
- Subject is able to understand and communicate in German
Who cannot join
- Any finding in the medical examination (including BP (blood pressure), PR (pulse rate) or ECG (electro cardiogramm) is deviating from normal and judged as clinically relevant by the investigator
- Pulse rate outside 45-80 bpm (beats per minutes) or repeated measurement of systolic blood pressure greater than 140 mmHg, diastolic blood pressure greater than 90 mm Hg
- 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
Show all 24Show fewer
- 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 or hypersensitivity (including allergy to the trial medication or its excipients)
- Intake of drugs with a long half-life (more than 24 h) within 30 days or less than 10 half-lives 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 or that might prolong the QT/QTc interval
- Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication
- Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
- Inability to refrain from smoking during inhouse-confinement
- Alcohol abuse (consumption of more 30 g per day for males)
- Drug abuse or positive drug screening
- Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation 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
- A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males) or any other relevant ECG finding at screening
- 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 as unsuitable for inclusion by the investigator, 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
- Vulnerable subjects, e.g. subjects kept in detention, soldiers, employees of the sponsor or a clinical research organization, involved in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 691751 in Healthy Male Subjects
It is the objective of this MRD trial to investigate pharmacokinetics, pharmcodynamics, safety and tolerability of rising doses BI 691751 over a treatment period of 14 days to support the further clinical development of this LTA4H-inhibitor. Special emphasis will be given to detect potential effects of BI 691751 on heart rate.
- Conditions
- Healthy
- Being tested
- BI 691751, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 691751Drug
BI 691751 Dose 1
BI 691751Drug
BI 691751 Dose 2
BI 691751Drug
BI 691751 Dose 3
BI 691751Drug
BI 691751 Dose 4
BI 691751Drug
BI 691751 Dose 5
BI 691751Drug
BI 691751 Dose 6
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| BI 691751 Dose 1 | Experimental | multiple dose given over 14 days Receives: Drug: BI 691751 |
| BI 691751 Dose 2 | Experimental | multiple dose given over 14 days Receives: Drug: BI 691751 |
| BI 691751 Dose 3 | Experimental | multiple dose given over 14 days Receives: Drug: BI 691751 |
| BI 691751 Dose 4 | Experimental | multiple dose given over 14 days Receives: Drug: BI 691751 |
| BI 691751 Dose 5 | Experimental | multiple dose given over 14 days Receives: Drug: BI 691751 |
| BI 691751 Dose 6 | Experimental | multiple dose given over 14 days Receives: Drug: BI 691751 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
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
Percentage of subjects with drug-related Adverse events (AEs)
Measured: From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days
Secondary outcomes (4)
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)
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).
This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study.
Measured: 0 minutes (min), 10min, 20min, 40min, 1 hour (h), 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24h after first drug administration
Cmax (Maximum Measured Concentration of the Analyte Inplasma)
Cmax (maximum measured concentration of the analyte inplasma).
This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study.
Measured: 0 minutes (min), 10min, 20min, 40min, 1 hour (h), 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24h after first drug administration
AUCt,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t)
AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t).
This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study.
Measured: 312 hours (h), 312 h 10 minutes (min), 312h 20min, 312h 40min, 313, 313h 30min, 314h, 315h, 316h, 318h, 320h, 322h, 324h and 336h after first drug administration
Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t)
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t).
This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study.
Measured: 312 hours (h), 312 h 10 minutes (min), 312h 20min, 312h 40min, 313, 313h 30min, 314h, 315h, 316h, 318h, 320h, 322h, 324h and 336h after first drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startMay 2014
- Primary completionJul 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 18 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
- NCT02148107
- Sponsor's protocol ID
- 1334.2
- Other IDs
- 2013-003813-17
- Status last verified
- Feb 2016
- First submitted
- 19 May 2014
- Last updated
- 29 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 691751 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02148107
- Acronym / sponsor ID
- 1334.2
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 28 May 2014 (estimated)
- Results
- Posted 29 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is the objective of this MRD trial to investigate pharmacokinetics, pharmcodynamics, safety and tolerability of rising doses BI 691751 over a treatment period of 14 days to support the further clinical development of this LTA4H-inhibitor. Special emphasis will be given to detect potential effects of BI 691751 on heart rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| BI 691751 Dose 1 | Experimental | Drug: BI 691751multiple dose given over 14 days |
| BI 691751 Dose 2 | Experimental | Drug: BI 691751multiple dose given over 14 days |
| BI 691751 Dose 3 | Experimental | Drug: BI 691751multiple dose given over 14 days |
| BI 691751 Dose 4 | Experimental | Drug: BI 691751multiple dose given over 14 days |
| BI 691751 Dose 5 | Experimental | Drug: BI 691751multiple dose given over 14 days |
| BI 691751 Dose 6 | Experimental | Drug: BI 691751multiple dose given over 14 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male subjects according to the investigator´s assessment, based on a complete medical history including a physical examination, vital signs (BP (blood pressure), PR (pulse rate), 12-lead ECG (electro cardiogramm), and clinical laboratory tests
- Age of 18 to 50 years (incl.)
- BMI (body mass index) 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(Good Clinical Practice) and local legislation
- Subject is able to understand and communicate in German
Key exclusion criteria (24 listed)
- Any finding in the medical examination (including BP (blood pressure), PR (pulse rate) or ECG (electro cardiogramm) is deviating from normal and judged as clinically relevant by the investigator
- Pulse rate outside 45-80 bpm (beats per minutes) or repeated measurement of systolic blood pressure greater than 140 mmHg, diastolic blood pressure greater than 90 mm Hg
- 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 |
|---|---|---|
| BI 691751BI 691751 Dose 1 | Drug | BI 691751 Dose 1 |
| BI 691751BI 691751 Dose 2 | Drug | BI 691751 Dose 2 |
| BI 691751BI 691751 Dose 3 | Drug | BI 691751 Dose 3 |
| BI 691751BI 691751 Dose 4 | Drug | BI 691751 Dose 4 |
| BI 691751BI 691751 Dose 5 | Drug | BI 691751 Dose 5 |
| BI 691751BI 691751 Dose 6 | Drug | BI 691751 Dose 6 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Percentage of Subjects With Drug-related Adverse Events
Time frame: From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days
Percentage of subjects with drug-related Adverse events (AEs)
4 secondary outcomes
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 minutes (min), 10min, 20min, 40min, 1 hour (h), 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24h after first drug administration
Cmax (Maximum Measured Concentration of the Analyte Inplasma)
Time frame: 0 minutes (min), 10min, 20min, 40min, 1 hour (h), 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24h after first drug administration
AUCt,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t)
Time frame: 312 hours (h), 312 h 10 minutes (min), 312h 20min, 312h 40min, 313, 313h 30min, 314h, 315h, 316h, 318h, 320h, 322h, 324h and 336h after first drug administration
Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t)
Time frame: 312 hours (h), 312 h 10 minutes (min), 312h 20min, 312h 40min, 313, 313h 30min, 314h, 315h, 316h, 318h, 320h, 322h, 324h and 336h after first drug administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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 BI 691751 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 5 inclusion and 24 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 29 Feb 2016. 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?
Yes. Results are posted in the registry (first posted 29 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (time frame: From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days). 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 29 Feb 2016.