HealthyPhase 1NCT01343706

Safety Tolerability and Pharmacokinetic of BI 409306

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.

Trial summary

The primary objective of the current study is to investigate the safety and tolerability of BI 409306 in healthy male genotyped volunteers following oral administration of single rising doses. Read more about this study

Who is it for?: Ages 21 to 50 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: 80 participants
Where: 1 siteGermany
Study dates: 1 Apr 2011to 5 Aug 2011
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 21 to 50 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 (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
Age > 21 and Age < 50 years
Body Mass Index (BMI) > 18.5 and BMI < 29.9 kg/m2

Who cannot join

Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (including but not limited to any kind of seizures, stroke or psychiatric disorders) within the past 6 month
History of relevant orthostatic hypotension, fainting spells or blackouts.

Show all 12Show fewer

Chronic or relevant acute infections
History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
Any laboratory value outside the reference range that is of clinical relevance
A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms);
A history of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)

Trial locations and contacts

1 site in 1 country.

Germany1 site

1289.1.1 Boehringer Ingelheim Investigational Site
Ingelheim

Other trials in Germany

About this study

Official title: A Randomized, Double-blind, Placebo-controlled (Within Dose Groups) Phase I Study to Assess Safety, Tolerability and Pharmacokinetics of Single Rising Doses 0.5 mg to 500 mg of BI 409306 Administered Orally in Healthy Male Volunteers

The primary objective of the current study is to investigate the safety and tolerability of BI 409306 in healthy male genotyped volunteers following oral administration of single rising doses.

The secondary objectives are: (1) to explore dose proportionality of BI 409306 as immediate release solid oral dosage, (2) to explore the relative bioavailability of BI 409306 when administered as immediate release solid oral dosage compared to oral drinking solution and (3) to compare the safety and pharmacokinetic profiles between two different groups of genotyped subjects.

Conditions: Healthy
Being tested: Placebo, BI 409306

What participants receive

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

PlaceboDrug
Solution for oral administration
PlaceboDrug
Immediate release solid oral dosage (film-coated tablet)
BI 409306Drug
Immediate release solid oral dosage (film-coated tablet)
BI 409306Drug
solution for oral administration

Study groups in NCT01343706
Study group	Role	What they receive
BI 409306 0.5 mg PiB [EM]	Experimental	Extensive metaboliser [EM] subjects administered one single dose of 0.5 milligram (mg) BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg /milliliter (mL)) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours. Receives: Drug: BI 409306
BI 409306 2 mg PiB [EM]	Experimental	EM subjects administered one single dose of 2 mg BI 409306 PiB reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 milliliter drinking water) after an overnight fast of at least 10 hours. Receives: Drug: BI 409306
BI 409306 5 mg PiB followed by BI 409306 5 mg Tablet [EM]	Experimental	EM subjects administered one single dose of 5 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/ mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 1; followed by a washout period of 5 days; followed by one single dose of 5 mg BI 409306 immediate release tablet administered orally with 240 mL water after an overnight fast of at least 10 hours in period 2. Receives: Drug: BI 409306
BI 409306 10 mg Tablet [EM]	Experimental	EM subjects administered 2 immediate release tablets of 5 mg BI 409306 as a single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours. Receives: Drug: BI 409306
BI 409306 25 mg Tablet [EM]	Experimental	EM subjects administered 5 immediate release tablets of 5 mg BI 409306 as a single dose (total dosage: 25 mg) orally with 240 mL water after an overnight fast of at least 10 hours. Receives: Drug: BI 409306
BI 409306 50 mg Tablet followed by BI 409306 50mg PiB [EM]	Experimental	EM subjects administered one single dose of 50 mg BI 409306 immediate release tablet orally with 240 mL water in period 1; followed by a washout period of 5 days; followed by one single dose of 50 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution administered orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 2. Receives: Drug: BI 409306
BI 409306 100 mg Tablet [EM]	Experimental	EM subjects administered 2 immediate release tablets of 50 mg BI 409306 as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours. Receives: Drug: BI 409306
BI 409306 200 mg Tablet [EM]	Experimental	EM subjects administered 1 immediate release tablet of 150 mg and 1 immediate release tablet of 50 mg of BI 409306 together as single dose (total dosage: 200 mg) orally with 240 mL water after an overnight fast of at least 10 hours. Receives: Drug: BI 409306
BI 409306 350 mg Tablet [EM]	Experimental	EM subjects administered 2 immediate release tablet of 150 mg and 1 immediate release tablet of 50 mg of BI 409306 together as single dose (total dosage: 350 mg) orally with 240 mL water after an overnight fast of at least 10 hours. Receives: Drug: BI 409306
BI 409306 10 mg Tablet followed by BI 409306 100mg Tablet [PM]	Experimental	Poor metaboliser [PM] subjects administered 2 immediate release tablets of 5 mg BI 409306 as single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 1; followed by washout period of 5 days; followed by 2 immediate release tablets of 50 mg BI 409306 administered as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 2. Receives: Drug: BI 409306
Placebo matching to BI 409306 PiB	Placebo comparator	Subjects administered one single dose of placebo matching to BI 409306 powder in bottle (PiB) after an overnight fast of at least 10 hours. Receives: Drug: Placebo
Placebo matching to BI 409306 film-coated tablet	Placebo comparator	Subjects administered one single dose of placebo matching to the BI 409306 film-coated tablet (5 milligrams (mg), 50 mg, and 150 mg) orally with 240 mL water after an overnight fast of at least 10 hours. 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 investigator defined drug-related Adverse Events (AEs)
Measured: From first drug administration until 30 days after last drug administration; up to 31 days.
Percentage of Subjects With Clinical Relevant Abnormalities for Physical Examination, Vital Signs, Clinical Laboratory Tests, Oral Body Temperature and ECG
Percentage of subjects with Clinical Relevant abnormalities for Physical examination, Vital Signs blood pressure (BP), pulse rate (PR) respiratory rate (RR), orthostatic test), Clinical laboratory tests (haematology, clinical chemistry and urinalysis), Oral body temperature and ECG were reported.
Measured: Day 4
Percentage of Subjects Per Category for Assessment of Tolerability by Investigator
The investigator assessed global clinical assessment and tolerability of BI 409306 were reported in possible categories were 'good', 'satisfactory', 'not satisfactory', and 'bad'.
Measured: Day 4
Change From Baseline in Bond & Lader (B&L) Visual Analogue Scales (VAS)
The B\&L VAS scores were calculated from 16 item with each has a score range from 0 to 10 [cm]. The score of each of the 3 categories of effects ("alertness", "calmness", and "contentment") is a weighted average of the scores from the 16 items. The VAS score for alertness/calmness/contentment ranges from 0 to 10 (more alertness/calmness/contentment). The B\&L VAS data was analysed descriptively (change from baseline at 24 hour). The VAS assessment 2 h before drug administration was considered as baseline.
Measured: At 24 hours

Secondary outcomes (4)

Area Under the Concentration-time Curve of the BI 409306 in Plasma From Time 0 to Time of Last Quantifiable Data Point (AUC0-24)
AUC0-24, Area under the concentration-time curve of the BI 409306 in plasma over the time interval from 0 to the time of the last quantifiable data point is presented as geometric mean (gMean) and geometric coefficient of variation (gCV%). Pharmacokinetic samples were also collected at 48:00 and 72:00 hours after the drug administration for dose groups 10 mg onwards.
Measured: Pharmacokinetic samples were collected at 2:00 (hour: minute) before 0.167, 0.333, 0.5, 0.75, 1:00, 1.50, 2:00, 2.50, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, and 24:00 hours after the drug administration.
Area Under the Concentration-time Curve of the BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
AUC0-∞, Area under the concentration-time curve of the BI 409306 in plasma over the time interval from 0 extrapolated to infinity. Pharmacokinetic samples were also collected at 48:00 and 72:00 hours after the drug administration for dose groups 10 mg onwards.
Measured: Pharmacokinetic samples were collected at 2:00 (hour: minute) before 0.167, 0.333, 0.5, 0.75, 1:00, 1.50, 2:00, 2.50, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, and 24:00 hours after the drug administration.
Maximum Measured Concentration of the BI 409306 in Plasma (Cmax)
Cmax, Maximum measured concentration of the BI 409306 in plasma. Pharmacokinetic samples were also collected at 48:00 and 72:00 hours after the drug administration for dose groups 10 mg onwards.
Measured: Pharmacokinetic samples were collected at 2:00 (hour: minute) before 0.167, 0.333, 0.5, 0.75, 1:00, 1.50, 2:00, 2.50, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, and 24:00 hours after the drug administration.
Amount of BI 409306 Eliminated in Urine From the Time Point t1 to Time Point t2 (Ae0-4)
Ae0-4, Amount of BI 409306 eliminated in urine from the time point t1(0) to time point t2(4). Urine samples were obtained 24:00 to 48:00 and 48:00 to 72:00 hours after oral administration were obtained only from dose group 10 mg onwards.
Measured: Urine samples were obtained pre-dose and sampling intervals 0:00 to 4:00, 4:00 to 8:00, 8:00 to 12:00 and 12:00 to 24:00 hours after oral administration.

Timeline

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

1 Apr 20115 Aug 2011

First posted28 Apr 2011 (estimated)
Study start1 Apr 2011
Primary completion1 Aug 2011
Study completion5 Aug 2011

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: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01343706
Sponsor's protocol ID: 1289.1
Other IDs: 2010-023604-27
Status last verified: Apr 2024
First submitted: 6 Apr 2011
Last updated: 25 Apr 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 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled (Within Dose Groups) Phase I Study to Assess Safety, Tolerability and Pharmacokinetics of Single Rising Doses 0.5 mg to 500 mg of BI 409306 Administered Orally in Healthy Male Volunteers
ClinicalTrials.gov ID: NCT01343706
Acronym / sponsor ID: 1289.1
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 1 Apr 2011 (actual)
Primary completion: 1 Aug 2011 (actual)
Study completion: 5 Aug 2011 (actual)
First posted: 28 Apr 2011 (estimated)
Results: Posted 12 Mar 2024

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 409306 in healthy male genotyped volunteers following oral administration of single rising doses.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 12

Arm	Type	Receives
BI 409306 0.5 mg PiB [EM]	Experimental	Drug: BI 409306Extensive metaboliser [EM] subjects administered one single dose of 0.5 milligram (mg) BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg /milliliter (mL)) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours.
BI 409306 2 mg PiB [EM]	Experimental	Drug: BI 409306EM subjects administered one single dose of 2 mg BI 409306 PiB reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 milliliter drinking water) after an overnight fast of at least 10 hours.
BI 409306 5 mg PiB followed by BI 409306 5 mg Tablet [EM]	Experimental	Drug: BI 409306EM subjects administered one single dose of 5 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/ mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 1; followed by a washout period of 5 days; followed by one single dose of 5 mg BI 409306 immediate release tablet administered orally with 240 mL water after an overnight fast of at least 10 hours in period 2.
BI 409306 10 mg Tablet [EM]	Experimental	Drug: BI 409306EM subjects administered 2 immediate release tablets of 5 mg BI 409306 as a single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours.
BI 409306 25 mg Tablet [EM]	Experimental	Drug: BI 409306EM subjects administered 5 immediate release tablets of 5 mg BI 409306 as a single dose (total dosage: 25 mg) orally with 240 mL water after an overnight fast of at least 10 hours.
BI 409306 50 mg Tablet followed by BI 409306 50mg PiB [EM]	Experimental	Drug: BI 409306EM subjects administered one single dose of 50 mg BI 409306 immediate release tablet orally with 240 mL water in period 1; followed by a washout period of 5 days; followed by one single dose of 50 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution administered orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 2.
BI 409306 100 mg Tablet [EM]	Experimental	Drug: BI 409306EM subjects administered 2 immediate release tablets of 50 mg BI 409306 as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours.
BI 409306 200 mg Tablet [EM]	Experimental	Drug: BI 409306EM subjects administered 1 immediate release tablet of 150 mg and 1 immediate release tablet of 50 mg of BI 409306 together as single dose (total dosage: 200 mg) orally with 240 mL water after an overnight fast of at least 10 hours.
BI 409306 350 mg Tablet [EM]	Experimental	Drug: BI 409306EM subjects administered 2 immediate release tablet of 150 mg and 1 immediate release tablet of 50 mg of BI 409306 together as single dose (total dosage: 350 mg) orally with 240 mL water after an overnight fast of at least 10 hours.
BI 409306 10 mg Tablet followed by BI 409306 100mg Tablet [PM]	Experimental	Drug: BI 409306Poor metaboliser [PM] subjects administered 2 immediate release tablets of 5 mg BI 409306 as single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 1; followed by washout period of 5 days; followed by 2 immediate release tablets of 50 mg BI 409306 administered as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 2.
Placebo matching to BI 409306 PiB	Placebo comparator	Drug: PlaceboSubjects administered one single dose of placebo matching to BI 409306 powder in bottle (PiB) after an overnight fast of at least 10 hours.
Placebo matching to BI 409306 film-coated tablet	Placebo comparator	Drug: PlaceboSubjects administered one single dose of placebo matching to the BI 409306 film-coated tablet (5 milligrams (mg), 50 mg, and 150 mg) orally with 240 mL water after an overnight fast of at least 10 hours.

Who may qualify

Ages: 21 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
Age > 21 and Age < 50 years
Body Mass Index (BMI) > 18.5 and BMI < 29.9 kg/m2

Key exclusion criteria (12 listed)

Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (including but not limited to any kind of seizures, stroke or psychiatric disorders) within the past 6 month

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
PlaceboSolution for oral administration	Drug	Placebo matching to BI 409306 PiB
PlaceboImmediate release solid oral dosage (film-coated tablet)	Drug	Placebo matching to BI 409306 film-coated tablet
BI 409306Immediate release solid oral dosage (film-coated tablet)	Drug	BI 409306 10 mg Tablet [EM], BI 409306 10 mg Tablet followed by BI 409306 100mg Tablet [PM], BI 409306 100 mg Tablet [EM], BI 409306 200 mg Tablet [EM], BI 409306 25 mg Tablet [EM], BI 409306 350 mg Tablet [EM], BI 409306 5 mg PiB followed by BI 409306 5 mg Tablet [EM], BI 409306 50 mg Tablet followed by BI 409306 50mg PiB [EM]
BI 409306solution for oral administration	Drug	BI 409306 0.5 mg PiB [EM], BI 409306 2 mg PiB [EM], BI 409306 5 mg PiB followed by BI 409306 5 mg Tablet [EM], BI 409306 50 mg Tablet followed by BI 409306 50mg PiB [EM]

Primary outcome

Percentage of Subjects With Drug-related Adverse Events
Time frame: From first drug administration until 30 days after last drug administration; up to 31 days.
Percentage of subjects with investigator defined drug-related Adverse Events (AEs)
Percentage of Subjects With Clinical Relevant Abnormalities for Physical Examination, Vital Signs, Clinical Laboratory Tests, Oral Body Temperature and ECG
Time frame: Day 4
Percentage of subjects with Clinical Relevant abnormalities for Physical examination, Vital Signs blood pressure (BP), pulse rate (PR) respiratory rate (RR), orthostatic test), Clinical laboratory tests (haematology, clinical chemistry and urinalysis), Oral body temperature and ECG were reported.
Percentage of Subjects Per Category for Assessment of Tolerability by Investigator
Time frame: Day 4
The investigator assessed global clinical assessment and tolerability of BI 409306 were reported in possible categories were 'good', 'satisfactory', 'not satisfactory', and 'bad'.
Change From Baseline in Bond & Lader (B&L) Visual Analogue Scales (VAS)
Time frame: At 24 hours
The B\&L VAS scores were calculated from 16 item with each has a score range from 0 to 10 [cm]. The score of each of the 3 categories of effects ("alertness", "calmness", and "contentment") is a weighted average of the scores from the 16 items. The VAS score for alertness/calmness/contentment ranges from 0 to 10 (more alertness/calmness/contentment). The B\&L VAS data was analysed descriptively (change from baseline at 24 hour). The VAS assessment 2 h before drug administration was considered as baseline.

4 secondary outcomes

Area Under the Concentration-time Curve of the BI 409306 in Plasma From Time 0 to Time of Last Quantifiable Data Point (AUC0-24)
Time frame: Pharmacokinetic samples were collected at 2:00 (hour: minute) before 0.167, 0.333, 0.5, 0.75, 1:00, 1.50, 2:00, 2.50, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, and 24:00 hours after the drug administration.
Area Under the Concentration-time Curve of the BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: Pharmacokinetic samples were collected at 2:00 (hour: minute) before 0.167, 0.333, 0.5, 0.75, 1:00, 1.50, 2:00, 2.50, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, and 24:00 hours after the drug administration.
Maximum Measured Concentration of the BI 409306 in Plasma (Cmax)
Time frame: Pharmacokinetic samples were collected at 2:00 (hour: minute) before 0.167, 0.333, 0.5, 0.75, 1:00, 1.50, 2:00, 2.50, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, and 24:00 hours after the drug administration.
Amount of BI 409306 Eliminated in Urine From the Time Point t1 to Time Point t2 (Ae0-4)
Time frame: Urine samples were obtained pre-dose and sampling intervals 0:00 to 4:00, 4:00 to 8:00, 8:00 to 12:00 and 12:00 to 24:00 hours after oral administration.

Results and safety

Results posted to the registry on 12 Mar 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 Matching to BI 409306 [EM and PM]	18	18
BI 409306 0.5 mg PiB [EM]	6	6
BI 409306 2 mg PiB [EM]	6	6
BI 409306 5 mg PiB Followed by BI 409306 5 mg Tablet [EM]	6	6
BI 409306 10 mg Tablet [EM]	6	6
BI 409306 25 mg Tablet [EM]	6	6
BI 409306 50 mg Tablet Followed by BI 409306 50mg PiB [EM]	6	6
Placebo to BI 409306 50 mg Tablet Followed by BI 409306 50 mg PiB [EM]	2	2
BI 409306 100 mg Tablet [EM]	6	5
BI 409306 200 mg Tablet [EM]	6	6
BI 409306 350 mg Tablet [EM]	6	6
BI 409306 10 mg Tablet Followed by BI 409306 100mg Tablet [PM]	6	6

Primary outcome: Percentage of Subjects With Drug-related Adverse Events

Time frame: From first drug administration until 30 days after last drug administration; up to 31 days.. Number. Unit: Percentage of subjects

Measure	Placebo Matching to BI (Period 1) n = 20	Placebo Matching to BI (Period 2) n = 4	BI 409306 0.5 mg PiB [EM] n = 6	BI 409306 2 mg PiB [EM] n = 6	BI 409306 5 mg PiB [EM] n = 6	BI 409306 5 mg Tablet [EM] n = 6	BI 409306 10 mg Tablet [EM] n = 6	BI 409306 25 mg Tablet [EM] n = 6	BI 409306 50 mg Tablet [EM] n = 6	BI 409306 50 mg PiB [EM] n = 8	BI 409306 100 mg Tablet [EM] n = 5	BI 409306 200 mg Tablet [EM] n = 6	BI 409306 350 mg Tablet [EM] n = 6	BI 409306 10 mg Tablet [PM] n = 6	BI 409306 100 mg Tablet [PM] n = 6
Value	0.0	0.0	0.0	33.3	0.0	16.7	0.0	0.0	0.0	0.0	40.0	66.7	66.7	33.3	50.0

Population analysed: Treated set (TS):This set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.

Primary outcome: Percentage of Subjects With Clinical Relevant Abnormalities for Physical Examination, Vital Signs, Clinical Laboratory Tests, Oral Body Temperature and ECG

Time frame: Day 4. Number. Unit: Percentage of subjects

Measure	Placebo Matching to BI (Period 1) n = 20	Placebo Matching to BI (Period 2) n = 4	BI 409306 0.5 mg PiB [EM] n = 6	BI 409306 2 mg PiB [EM] n = 6	BI 409306 5 mg PiB [EM] n = 6	BI 409306 5 mg Tablet EM n = 6	BI 409306 10 mg Tablet [EM] n = 6	BI 409306 25 mg Tablet [EM] n = 6	BI 409306 50 mg Tablet [EM] n = 6	BI 409306 50 mg PiB [EM] n = 8	BI 409306 100 mg Tablet [EM] n = 5	BI 409306 200 mg Tablet [EM] n = 6	BI 409306 350 mg Tablet [EM] n = 6	BI 409306 10 mg Tablet [PM] n = 6	BI 409306 100 mg Tablet [PM] n = 6
Value	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Population analysed: Treated set (TS):This set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.

Primary outcome: Percentage of Subjects Per Category for Assessment of Tolerability by Investigator

Time frame: Day 4. Number. Unit: Percentage of subjects

Measure	BI 409306 2 mg PiB [EM] n = 6	BI 409306 50 mg Tablet Followed by BI 409306 50mg PiB [EM] n = 6	Placebo to BI 409306 50 mg Tablet Followed by BI 409306 50 mg PiB [EM] n = 2	BI 409306 100 mg Tablet [EM] n = 5	BI 409306 200 mg Tablet [EM] n = 6	BI 409306 350 mg Tablet [EM] n = 6	BI 409306 10 mg Tablet Followed by BI 409306 100mg Tablet [PM] n = 6
Good	0	6	2	5	6	4	4
Satisfactory	1	0	0	0	0	2	1
Not satisfactory	0	0	0	0	0	0	1
Bad	0	0	0	0	0	0	0
Not assessable	0	0	0	0	0	0	0

Population analysed: Treated set (TS):This set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.

Primary outcome: Change From Baseline in Bond & Lader (B&L) Visual Analogue Scales (VAS)

Time frame: At 24 hours. Least squares mean (Standard Deviation). Unit: Score on a scale

Measure	Placebo Matching to BI (Period 1) n = 20	Placebo Matching to BI (Period 2) n = 4	BI 409306 0.5 mg PiB [EM] n = 6	BI 409306 2 mg PiB [EM] n = 6	BI 409306 5 mg PiB [EM] n = 6	BI 409306 5 mg Tablet [EM] n = 6	BI 409306 10 mg Tablet [EM] n = 6	BI 409306 25 mg Tablet [EM] n = 6	BI 409306 50 mg Tablet [EM] n = 6	BI 409306 50 mg PiB [EM] n = 8	BI 409306 100 mg Tablet [EM] n = 5	BI 409306 200 mg Tablet [EM] n = 6	BI 409306 350 mg Tablet [EM] n = 6	BI 409306 10 mg Tablet [PM] n = 6	BI 409306 100 mg Tablet [PM] n = 6
Alertness	-0.33 (1.26)	-0.04 (0.70)	-0.84 (1.11)	-1.18 (0.35)	-0.13 (0.70)	0.09 (0.56)	-0.33 (0.73)	-0.07 (0.97)	-0.92 (1.25)	-0.56 (0.54)	-0.26 (0.95)	-0.80 (0.55)	-0.21 (0.39)	-1.02 (1.24)	-1.88 (1.58)
Contentment	-0.30 (1.09)	0.06 (0.45)	-0.74 (1.02)	-0.68 (0.23)	-0.53 (0.68)	-0.12 (0.71)	0.04 (0.46)	0.00 (0.76)	-0.49 (0.84)	-0.35 (0.75)	-0.19 (0.73)	-0.59 (0.59)	-0.22 (0.50)	-0.64 (1.23)	-0.97 (0.71)
Calmness	-0.35 (1.34)	0.02 (0.21)	-0.48 (1.20)	-0.91 (0.99)	-0.45 (0.89)	-0.14 (1.59)	0.25 (1.04)	-0.39 (0.55)	-0.75 (1.35)	-0.47 (1.71)	0.05 (1.31)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration until 30 days after last drug administration; up to 31 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Matching to BI (Period 1)	0 of 20 (0%)	2 of 20 (10%)	0 of 20
Placebo Matching to BI (Period 2)	0 of 4 (0%)	1 of 4 (25%)	0 of 4
BI 409306 0.5 mg PiB [EM]	0 of 6 (0%)	0 of 6 (0%)	0 of 6
BI 409306 2 mg PiB [EM]	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
BI 409306 5 mg PiB [EM]	0 of 6 (0%)	0 of 6 (0%)	0 of 6
BI 409306 5 mg Tablet [EM]	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
BI 409306 10 mg Tablet [EM]	0 of 6 (0%)	0 of 6 (0%)	0 of 6
BI 409306 25 mg Tablet [EM]	0 of 6 (0%)	0 of 6 (0%)	0 of 6
BI 409306 50 mg Tablet [EM]	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
BI 409306 50mg PiB [EM]	0 of 8 (0%)	0 of 8 (0%)	0 of 8
BI 409306 100 mg Tablet [EM]	0 of 5 (0%)	2 of 5 (40%)	0 of 5
BI 409306 200 mg Tablet [EM]	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
BI 409306 350 mg Tablet [EM]	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
BI 409306 10 mg Tablet [PM]	0 of 6 (0%)	3 of 6 (50%)	0 of 6
BI 409306 100 mg Tablet [PM]	0 of 6 (0%)	3 of 6 (50%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 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 3 inclusion and 12 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 25 Apr 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 12 Mar 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?

Percentage of Subjects With Drug-related Adverse Events (time frame: From first drug administration until 30 days after last drug administration; up to 31 days.). The study lists 4 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 NCT01343706.

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 25 Apr 2024.