HealthyPhase 1NCT02438683

BI 409306 Cardiac Safety Trial in Healthy Volunteers

A Phase 1 study testing BI 409306 in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI 409306
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 1 siteGermany
Study dates: 4 May 2015to 13 Aug 2015
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 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests.
Age of 18 to 45 years (incl.)
BMI of 18.5 to 29.9 kg/m2 (incl.)
Waist-to-height ratio less than 0.5
Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
Ready and able to use highly effective methods of birth control that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the subject information.

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
Repeated measurement of
Systolic blood pressure less than 90 mm Hg or more than140 mmHg
Diastolic blood pressure less than 50 mm Hg or more than 90 mmHg
Pulse rate less than 45 bpm or more than 90 bpm
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance

Show all 33Show fewer

Any evidence of a concomitant disease judged as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the PK of the trial medication (except appendectomy and simple hernia repair)
Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological 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 (unless the subject quit smoking for at least 30 days prior to screening)
Alcohol abuse (consumption of more than 30 g per day)
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) or any other relevant ECG finding at screening
A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalaemia, 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
Any suicidal ideation of type 2 to 5 on the C-SSRS in the past 12 months (i.e. active suicidal thought, active suicidal thought with method, active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)
Any lifetime history of suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour).
In addition, the following trial-specific exclusion criteria apply:
CYP2C19 PM (no treatment allocation)
History of macular degeneration
Beard or unwillingness to shave for the trial (to facilitate appropriate measurements during CPX which requires wearing a face mask)
Physical disability that precludes safe and adequate CPX investigation
Known latex allergy

Trial locations and contacts

1 site in 1 country.

Germany1 site

1289.28.1 Boehringer Ingelheim Investigational Site
Biberach

Other trials in Germany

About this study

Official title: A Randomized, Double-blind, Double Dummy, Placebo-controlled, Three-way Crossover Study to Assess Cardiac Effects After Single Oral Doses of BI409306 Under Resting and Exercise Conditions in Healthy Male Volunteers

This trial will be conducted to further evaluate, in a controlled setting, potential cardiac effects of an anticipated therapeutic and supra-therapeutic dose of BI 409306 under resting and exercise conditions. Since the drug is being developed in part for a disease with an expectedly high number of elderly (AD), the characterization of cardiac safety of BI 409306 is considered to be important for the development of this compound.

Since the drug is being developed in part for a disease with an expectedly high number of elderly (AD), the characterization of cardiac safety of BI 409306 is considered to be important for the development of this compound.

Conditions: Healthy
Being tested: BI 409306, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BI 409306Drug
high dose, single dose, oral administration
BI 409306Drug
low dose, single dose, oral administration
PlaceboDrug
single dose, oral administration

Study groups in NCT02438683
Study group	Role	What they receive
Placebo under resting/exercise conditions	Placebo comparator	Participants received matching Placebo oral dose with 240 mL of water after a standardized light breakfast on Day 1 and Day 3 under resting/exercise conditions. Receives: Drug: Placebo
BI 409306 50 mg under resting/exercise conditions	Experimental	Participants received BI 409306 50 mg oral dose with 240 mL of water after a standardized light breakfast on Day 1 and Day 3 under resting/exercise conditions. Receives: Drug: BI 409306
BI 409306 200 mg under resting/exercise conditions	Experimental	Participants received BI 409306 200 mg oral dose with 240 mL of water after a standardized light breakfast on Day 1 and Day 3 under resting/exercise conditions. Receives: Drug: BI 409306

What is being measured

The primary outcome is the main question the study is designed to answer.

Slope of the Placebo-corrected Change From Baseline of Heart Rate at Rest and Plasma Concentration Between 0 to 10 Hours
Slope of the placebo-corrected change from baseline in resting heart rate (ΔΔHR) vs. plasma concentration of BI 409306, as assessed from 0 to 10 hours (h) after intake of trial medication. The predicted mean value (90% CI) of ΔΔHR at geometric Mean of Cmax of the corresponding dose group is presented in the measured values table. Primary analysis excluded measurement with missing values. Patients with available data were included.
Measured: Baseline and up to 10 hours
Maximum Difference to Placebo of the Change From Baseline in Heart Rate at Rest Between 0 to 4 Hours, Per 50 mg Dose Group
For 50 mg dose, the maximal difference in the change from baseline in resting HR for BI 409306 treatment compared with placebo treatment, as assessed from 0 to 4 hours after intake of trial medication (change from baseline in heart rate at rest between 0-4 hours at the time when maximum difference to placebo of the change from baseline was reached). The note "Not Calculated" represents that the endpoint was not planned to be analyzed for the particular arm and category as only pairwise comparisons were built, no difference to placebo is build. Maximum difference reached at 1 hour. Predicted mean changes from baseline (90% Cis) are shown in the measured value table.
Measured: Baseline and up to 4 hours
Maximum Difference to Placebo of the Change From Baseline in Heart Rate at Rest Between 0 to 4 Hours, Per 200 mg Dose Group
For 200 mg dose, the maximal difference in the change from baseline in resting HR for BI 409306 treatment compared with placebo treatment, as assessed from 0 to 4 hours after intake of trial medication (change from baseline in heart rate at rest between 0-4 hours at the time when maximum difference to placebo of the change from baseline was reached). The note "Not Calculated" represents that the endpoint was not planned to be analyzed for the particular arm and category as only pairwise comparisons were built, no difference to placebo is build. Maximum difference reached at 1 hour. Predicted mean changes from baseline (90% Cis) are shown in the measured value table.
Measured: Baseline and up to 4 hours

Secondary outcomes (5)

Slope of Placebo-corrected Change From Baseline of Time Between Start of the Q Wave and End of the T Wave in an ECG Corrected for Heart Rate Using the Fridericia Correction Formula (QTcF) at Rest and Plasma Concentration Between 0 to 10 Hours
Slope of placebo-corrected change from baseline in resting Fridericia correction formula QTcF vs. plasma concentration of BI 409306, as assessed from 0 to 10 h after intake of trial medication. The predicted mean value (90% CI) of ΔΔQTcF at geometric Mean of Cmax of the corresponding dose group is presented in the measured values table. Patients with available data were included.
Measured: Baseline and up to 10 hours
Maximum Difference to Placebo of the Change From Baseline of QTcF at Rest to Placebo Between 0 to 4 Hours, Per 50 mg Dose Group
For 50 mg dose, the maximal difference in the change from baseline in resting Fridericia correction formula QTcF for BI 409306 treatment compared with placebo treatment, as assessed from 0 to 4 hours after intake of trial medication (change from baseline in resting QTcF at rest between 0-4 hours at the time when maximum difference to placebo of the change from baseline was reached). The note "Not Calculated" represents that the endpoint was not planned to be analyzed for the particular arm and category as only pairwise comparisons were built, no difference to placebo is build. Maximum difference reached at 20 minutes. The predicted mean changes from baseline (90% Cis) are shown in the measured value table.
Measured: Baseline and up to 4 hours
Maximum Difference to Placebo of the Change From Baseline of QTcF at Rest to Placebo Between 0 to 4 Hours, Per 200 mg Dose Group
For 200 mg dose, the maximal difference in the change from baseline in resting Fridericia correction formula QTcF for BI 409306 treatment compared with placebo treatment, as assessed from 0 to 4 hours after intake of trial medication (change from baseline in resting QTcF at rest between 0-4 hours at the time when maximum difference to placebo of the change from baseline was reached). The note "Not Calculated" represents that the endpoint was not planned to be analyzed for the particular arm and category as only pairwise comparisons were built, no difference to placebo is build. Maximum difference reached at 20 minutes. The predicted mean changes from baseline (90% Cis) are shown in the measured value table.
Measured: Baseline and up to 4 hours
Slope of the Placebo-corrected Maximum Heart Rate During Exercise vs. Plasma Concentration of BI 409306
Slope of the placebo-corrected maximum heart rate during exercise vs. plasma concentration of BI 409306. Patients with available data were included. Exercise testing was completed before gMean Cmax was reached for BI 409306 200 mg arm. The predicted mean value (90% CI) at geometric Mean of Cmax of the corresponding dose group is presented in the measured values table.
Measured: 20 minutes and 2 hours 20 minutes after drug intake
Slope of the Placebo Corrected Change From Maximum Heart Rate 1 and 5 Minutes After End of Exercise and Plasma Concentration
Slope of the placebo-corrected difference between maximum heart rate (HR) during exercise and recovery HR at 1 and 5 minutes (min) after the end of exercise vs. plasma concentration of BI 409306. The note "Not Calculated" represents that the plasma concentrations 1 min after the end of exercise did not reach gMean Cmax for the perticular arm. Patients with available data were included. The predicted mean value (90% CI) at geometric Mean of Cmax of the corresponding dose group is presented in the measured values table.
Measured: 20 minutes and 2 hours 20 minutes after drug intake

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 May 201513 Aug 2015

First posted8 May 2015 (estimated)
Study start4 May 2015
Primary completion12 Aug 2015
Study completion13 Aug 2015

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: Crossover
Masking: Double blind
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02438683
Sponsor's protocol ID: 1289.28
Other IDs: 2014-005132-34, 2014
Status last verified: Oct 2024
First submitted: 6 May 2015
Last updated: 26 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Double Dummy, Placebo-controlled, Three-way Crossover Study to Assess Cardiac Effects After Single Oral Doses of BI409306 Under Resting and Exercise Conditions in Healthy Male Volunteers
ClinicalTrials.gov ID: NCT02438683
Acronym / sponsor ID: 1289.28
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 4 May 2015 (actual)
Primary completion: 12 Aug 2015 (actual)
Study completion: 13 Aug 2015 (actual)
First posted: 8 May 2015 (estimated)
Results: Posted 3 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Number of arms: 3

Arm	Type	Receives
Placebo under resting/exercise conditions	Placebo comparator	Drug: PlaceboParticipants received matching Placebo oral dose with 240 mL of water after a standardized light breakfast on Day 1 and Day 3 under resting/exercise conditions.
BI 409306 50 mg under resting/exercise conditions	Experimental	Drug: BI 409306Participants received BI 409306 50 mg oral dose with 240 mL of water after a standardized light breakfast on Day 1 and Day 3 under resting/exercise conditions.
BI 409306 200 mg under resting/exercise conditions	Experimental	Drug: BI 409306Participants received BI 409306 200 mg oral dose with 240 mL of water after a standardized light breakfast on Day 1 and Day 3 under resting/exercise conditions.

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests.
Age of 18 to 45 years (incl.)
BMI of 18.5 to 29.9 kg/m2 (incl.)
Waist-to-height ratio less than 0.5
Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Key exclusion criteria (33 listed)

Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
Repeated measurement of
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 409306high dose, single dose, oral administration	Drug	BI 409306 200 mg under resting/exercise conditions
BI 409306low dose, single dose, oral administration	Drug	BI 409306 50 mg under resting/exercise conditions
Placebosingle dose, oral administration	Drug	Placebo under resting/exercise conditions

Primary outcome

Slope of the Placebo-corrected Change From Baseline of Heart Rate at Rest and Plasma Concentration Between 0 to 10 Hours
Time frame: Baseline and up to 10 hours
Slope of the placebo-corrected change from baseline in resting heart rate (ΔΔHR) vs. plasma concentration of BI 409306, as assessed from 0 to 10 hours (h) after intake of trial medication. The predicted mean value (90% CI) of ΔΔHR at geometric Mean of Cmax of the corresponding dose group is presented in the measured values table. Primary analysis excluded measurement with missing values. Patients with available data were included.
Maximum Difference to Placebo of the Change From Baseline in Heart Rate at Rest Between 0 to 4 Hours, Per 50 mg Dose Group
Time frame: Baseline and up to 4 hours
For 50 mg dose, the maximal difference in the change from baseline in resting HR for BI 409306 treatment compared with placebo treatment, as assessed from 0 to 4 hours after intake of trial medication (change from baseline in heart rate at rest between 0-4 hours at the time when maximum difference to placebo of the change from baseline was reached). The note "Not Calculated" represents that the endpoint was not planned to be analyzed for the particular arm and category as only pairwise comparisons were built, no difference to placebo is build. Maximum difference reached at 1 hour. Predicted mean changes from baseline (90% Cis) are shown in the measured value table.
Maximum Difference to Placebo of the Change From Baseline in Heart Rate at Rest Between 0 to 4 Hours, Per 200 mg Dose Group
Time frame: Baseline and up to 4 hours
For 200 mg dose, the maximal difference in the change from baseline in resting HR for BI 409306 treatment compared with placebo treatment, as assessed from 0 to 4 hours after intake of trial medication (change from baseline in heart rate at rest between 0-4 hours at the time when maximum difference to placebo of the change from baseline was reached). The note "Not Calculated" represents that the endpoint was not planned to be analyzed for the particular arm and category as only pairwise comparisons were built, no difference to placebo is build. Maximum difference reached at 1 hour. Predicted mean changes from baseline (90% Cis) are shown in the measured value table.

5 secondary outcomes

Slope of Placebo-corrected Change From Baseline of Time Between Start of the Q Wave and End of the T Wave in an ECG Corrected for Heart Rate Using the Fridericia Correction Formula (QTcF) at Rest and Plasma Concentration Between 0 to 10 Hours
Time frame: Baseline and up to 10 hours
Maximum Difference to Placebo of the Change From Baseline of QTcF at Rest to Placebo Between 0 to 4 Hours, Per 50 mg Dose Group
Time frame: Baseline and up to 4 hours
Maximum Difference to Placebo of the Change From Baseline of QTcF at Rest to Placebo Between 0 to 4 Hours, Per 200 mg Dose Group
Time frame: Baseline and up to 4 hours
Slope of the Placebo-corrected Maximum Heart Rate During Exercise vs. Plasma Concentration of BI 409306
Time frame: 20 minutes and 2 hours 20 minutes after drug intake
Slope of the Placebo Corrected Change From Maximum Heart Rate 1 and 5 Minutes After End of Exercise and Plasma Concentration
Time frame: 20 minutes and 2 hours 20 minutes after drug intake

Results and safety

Results posted to the registry on 3 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo /50 mg/ 200 mg of BI 409306	4	3
Placebo /200 mg/ 50 mg of BI 409306	3	3
50 mg / Placebo / 200 mg of BI 409306	2	2
50 mg / 200 mg / Placebo of BI 409306	3	3
200 mg / Placebo / 50 mg of BI 409306	4	4
200 mg / 50 mg / Placebo of BI 409306	4	4

Primary outcome: Slope of the Placebo-corrected Change From Baseline of Heart Rate at Rest and Plasma Concentration Between 0 to 10 Hours

Time frame: Baseline and up to 10 hours. Geometric mean (90% Confidence Interval). Unit: beats/min

Measure	BI 409306 50 mg Under Resting Conditions n = 16	BI 409306 200 mg Under Resting Conditions n = 16
Value	0.80 (-0.76 to 2.36)	5.46 (2.44 to 8.49)

BI 409306 50 mg Under Resting Conditions vs BI 409306 200 mg Under Resting Conditions: Slope: 0.0029 (95% CI 0.0012 to 0.0046)

Population analysed: The pharmacokinetics electrocardiogram set (PKECGS) included all subjects from the electrocardiogram (ECG) set (all subjects in the treated set who had at least 1 baseline and 1 post-baseline assessment in 1 treatment period for at least 1 ECG interval endpoint) who provided at least 1 valid drug plasma concentration and a corresponding ECG or oxygen variable in any period. Patients in the treatment groups are not mutually exclusive.

Primary outcome: Maximum Difference to Placebo of the Change From Baseline in Heart Rate at Rest Between 0 to 4 Hours, Per 50 mg Dose Group

Time frame: Baseline and up to 4 hours. Least squares mean (Standard Error). Unit: beats/min

Measure	BI 409306 50 mg Under Resting Conditions n = 17	Placebo Under Resting Conditions n = 18
Value	4.33 (1.33)	0.48 (1.28)

BI 409306 50 mg Under Resting Conditions vs Placebo Under Resting Conditions: Mean Difference (Net): 3.85 (90% CI 0.73 to 6.97)

Population analysed: The electrocardiogram analysis set (ECGS) consisted of all subjects in the treated set who had at least 1 baseline and 1 post-baseline assessment (measured at rest) in 1 treatment period for at least 1 ECG interval endpoint. The ECGS was used for all ECG analyses except for those assessing the relationship between plasma concentration and ECG variables. Patients in the treatment groups are not mutually exclusive.

Primary outcome: Maximum Difference to Placebo of the Change From Baseline in Heart Rate at Rest Between 0 to 4 Hours, Per 200 mg Dose Group

Time frame: Baseline and up to 4 hours. Least squares mean (Standard Error). Unit: beats/min

Measure	BI 409306 200 mg Under Resting Conditions n = 17	Placebo Under Resting Conditions n = 18
Value	5.85 (1.35)	0.92 (1.33)

BI 409306 200 mg Under Resting Conditions vs Placebo Under Resting Conditions: Mean Difference (Net): 4.93 (90% CI 1.69 to 8.16)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From drug administration until end of washout period or end of trial examination, up to 10 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Under Resting Conditions	0 of 20 (0%)	4 of 20 (20%)	Not reported
Placebo Under Exercise Conditions	0 of 20 (0%)	1 of 20 (5%)	Not reported
BI 409306 50 mg Under Resting Conditions	0 of 20 (0%)	0 of 20 (0%)	Not reported
BI 409306 50 mg Under Exercise Conditions	0 of 19 (0%)	1 of 19 (5.3%)	Not reported
BI 409306 200 mg Under Resting Conditions	0 of 19 (0%)	9 of 19 (47.4%)	Not reported
BI 409306 200 mg Under Exercise Conditions	0 of 19 (0%)	7 of 19 (36.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

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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 409306 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 6 inclusion and 33 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 26 Oct 2024. 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 3 Sep 2024). 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?

Slope of the Placebo-corrected Change From Baseline of Heart Rate at Rest and Plasma Concentration Between 0 to 10 Hours (time frame: Baseline and up to 10 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02438683.

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 26 Oct 2024.