HealthyPhase 1NCT03588390

This Study in Healthy Men Tests How Different Doses of BI 1323495 Are Taken up in the Body and How Well They Are Tolerated.

A Phase 1 study testing BI 1323495 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 this trial is to investigate the safety and tolerability of BI 1323495 in healthy male subjects following oral administration of single rising doses. Secondary objectives are the exploration of the pharmacokinetics (PK) including dose proportionality and pharmacodynamics (PD) of BI 1323495… Read more about this study

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 1323495
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 63 participants
Where: 1 siteGermany
Study dates: 31 Jul 2018to 14 Nov 2018
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 male subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood Pressure [BP], Pulse Rate [PR]), 12-lead Electrocardiogram [ECG], and clinical laboratory tests
Age of 18 to 45 years (incl.)
Body Mass Index [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 Good Clinical Practice[ GCP] and local legislation

Who cannot join

Any finding in the medical examination (including Blood Pressure [BP], Pulse Rate [PR] or Electrocardiogram [ECG]) is deviating from normal and judged as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
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
Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)

Show all 28Show fewer

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)
Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)
Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication, or current participation in another trial involving administration of investigational drug
Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
Inability to refrain from smoking on specified trial days
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, 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
In addition, the following trial-specific exclusion criteria apply:
Male subjects with female partner of childbearing potential who are unwilling to use male contraception (condom or sexual abstinence) from the first administration of trial medication until 30 days after last administration of trial medication
Current or history of relevant kidney, urinary tract diseases or abnormalities (e.g. nephrolithiasis, hydronephrosis, acute or chronic nephritis, renal injury, renal failure)
Estimated glomerular filtration rate according to CKD-EPI formula < 90 mL/min at screening
Within 10 days prior to administration of trial medication, use of any drug that could reasonably inhibit platelet aggregation or coagulation (e.g., acetylsalicylic acid)
Further exclusion criteria apply

Trial locations and contacts

1 site in 1 country.

Germany1 site

Humanpharmakologisches Zentrum Biberach
Biberach, 88397

Other trials in Germany

About this study

Official title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses of BI 1323495 in Healthy Male Subjects (Single-blind, Partially Randomised, Placebo-controlled Parallel Group Design)

The primary objective of this trial is to investigate the safety and tolerability of BI 1323495 in healthy male subjects following oral administration of single rising doses.

Secondary objectives are the exploration of the pharmacokinetics (PK) including dose proportionality and pharmacodynamics (PD) of BI 1323495 after single dosing and the assessment of the PK/PD relationship.

Conditions: Healthy
Being tested: BI 1323495, Placebo

What participants receive

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

BI 1323495Drug
Low strength tablet
BI 1323495Drug
Middle strength tablet
BI 1323495Drug
High strength tablet
PlaceboDrug
Placebo to low strength tablet
PlaceboDrug
Placebo to middle strength tablet
PlaceboDrug
Placebo to high strength tablet

Study groups in NCT03588390
Study group	Role	What they receive
Dose Group 1	Experimental	Participants were orally administered single dose of BI 1323495 dose group 1 or matching placebo film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. Receives: Drug: BI 1323495; Drug: Placebo
Dose Group 2	Experimental	Participants were orally administered single dose of BI 1323495 dose group 2 or matching placebo film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. Receives: Drug: BI 1323495; Drug: Placebo
Dose Group 3	Experimental	Participants were orally administered single dose of BI 1323495 dose group 3 or matching placebo film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. Receives: Drug: BI 1323495; Drug: Placebo
Dose Group 4	Experimental	Participants were orally administered single dose of BI 1323495 dose group 4 or matching placebo film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. Receives: Drug: BI 1323495; Drug: Placebo
Dose Group 5	Experimental	Participants were orally administered single dose of BI 1323495 dose group 5 or matching placebo film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. Receives: Drug: BI 1323495; Drug: Placebo
Dose Group 6	Experimental	Participants were orally administered single dose of BI 1323495 dose group 6 or matching placebo film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. Receives: Drug: BI 1323495; Drug: Placebo
Dose Group 7	Experimental	Participants were orally administered single dose of BI 1323495 dose group 7 or matching placebo film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. Receives: Drug: BI 1323495; Drug: Placebo
Dose Group 8	Experimental	Participants were orally administered single dose of BI 1323495 dose group 8 or matching placebo film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. Receives: Drug: BI 1323495; Drug: Placebo

What is being measured

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

Percentage of Participants With Drug-related Adverse Events
Percentage of participants with drug-related adverse events.
Measured: From drug administration until end of trial, up to 15 days.

Secondary outcomes (2)

Area Under the Concentration-time Curve of BI 1323495 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Area under the concentration-time curve of BI 1323495 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) after single oral administration of BI 1323495.
Measured: 1 hour (h) before drug administration and 1, 2, 3, 4, 6, 7, 8, 9, 10, 12, 24, 34, 48, 72 and 96 h and additionally 4.75, 5.5, 6.5, 7.5 h for dose group 1/2/3 and 0.333, 0.667, 1.5, 5 h for dose group 4/5/6/7/8 after drug administration.
Maximum Measured Concentration of BI 1323495 in Plasma (Cmax)
Maximum measured concentration of BI 1323495 in plasma (Cmax) after single oral administration of BI 1323495.
Measured: 1 hour (h) before drug administration and 1, 2, 3, 4, 6, 7, 8, 9, 10, 12, 24, 34, 48, 72 and 96 h and additionally 4.75, 5.5, 6.5, 7.5 h for dose group 1/2/3 and 0.333, 0.667, 1.5, 5 h for dose group 4/5/6/7/8 after drug administration.

Timeline

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

31 Jul 201814 Nov 2018

First posted17 Jul 2018
Study start31 Jul 2018
Primary completion14 Nov 2018
Study completion14 Nov 2018

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: Single blind
Who is masked: Participant
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03588390
Sponsor's protocol ID: 1405-0001
Other IDs: 2017-004899-62, 2017
Status last verified: Jul 2023
First submitted: 6 Jul 2018
Last updated: 22 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: 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, except for the following exclusions: 1. Studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. Studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). Requestors can use the following link http:// trials.boehringer-ingelheim.com/ to: 1. find information in order to request access to clinical study data, for listed studies. 2. request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement.

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?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses of BI 1323495 in Healthy Male Subjects (Single-blind, Partially Randomised, Placebo-controlled Parallel Group Design)
ClinicalTrials.gov ID: NCT03588390
Acronym / sponsor ID: 1405-0001
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 31 Jul 2018 (actual)
Primary completion: 14 Nov 2018 (actual)
Study completion: 14 Nov 2018 (actual)
First posted: 17 Jul 2018 (actual)
Results: Posted 22 Feb 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 this trial is to investigate the safety and tolerability of BI 1323495 in healthy male subjects following oral administration of single rising doses.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 8

Arm	Type	Receives
Dose Group 1	Experimental	Drug: BI 1323495, Drug: PlaceboParticipants were orally administered single dose of BI 1323495 dose group 1 or matching placebo film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
Dose Group 2	Experimental	Drug: BI 1323495, Drug: PlaceboParticipants were orally administered single dose of BI 1323495 dose group 2 or matching placebo film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
Dose Group 3	Experimental	Drug: BI 1323495, Drug: PlaceboParticipants were orally administered single dose of BI 1323495 dose group 3 or matching placebo film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
Dose Group 4	Experimental	Drug: BI 1323495, Drug: PlaceboParticipants were orally administered single dose of BI 1323495 dose group 4 or matching placebo film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
Dose Group 5	Experimental	Drug: BI 1323495, Drug: PlaceboParticipants were orally administered single dose of BI 1323495 dose group 5 or matching placebo film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
Dose Group 6	Experimental	Drug: BI 1323495, Drug: PlaceboParticipants were orally administered single dose of BI 1323495 dose group 6 or matching placebo film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
Dose Group 7	Experimental	Drug: BI 1323495, Drug: PlaceboParticipants were orally administered single dose of BI 1323495 dose group 7 or matching placebo film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
Dose Group 8	Experimental	Drug: BI 1323495, Drug: PlaceboParticipants were orally administered single dose of BI 1323495 dose group 8 or matching placebo film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.

Who may qualify

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

Key inclusion criteria (4 listed)

Healthy male subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood Pressure [BP], Pulse Rate [PR]), 12-lead Electrocardiogram [ECG], and clinical laboratory tests
Age of 18 to 45 years (incl.)
Body Mass Index [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 Good Clinical Practice[ GCP] and local legislation

Key exclusion criteria (28 listed)

Any finding in the medical examination (including Blood Pressure [BP], Pulse Rate [PR] or Electrocardiogram [ECG]) is deviating from normal and judged as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
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 1323495Low strength tablet	Drug	Dose Group 1, Dose Group 2, Dose Group 3
BI 1323495Middle strength tablet	Drug	Dose Group 4, Dose Group 5, Dose Group 6
BI 1323495High strength tablet	Drug	Dose Group 7, Dose Group 8
PlaceboPlacebo to low strength tablet	Drug	Dose Group 1, Dose Group 2, Dose Group 3
PlaceboPlacebo to middle strength tablet	Drug	Dose Group 4, Dose Group 5, Dose Group 6
PlaceboPlacebo to high strength tablet	Drug	Dose Group 7, Dose Group 8

Primary outcome

Percentage of Participants With Drug-related Adverse Events
Time frame: From drug administration until end of trial, up to 15 days.
Percentage of participants with drug-related adverse events.

2 secondary outcomes

Area Under the Concentration-time Curve of BI 1323495 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: 1 hour (h) before drug administration and 1, 2, 3, 4, 6, 7, 8, 9, 10, 12, 24, 34, 48, 72 and 96 h and additionally 4.75, 5.5, 6.5, 7.5 h for dose group 1/2/3 and 0.333, 0.667, 1.5, 5 h for dose group 4/5/6/7/8 after drug administration.
Maximum Measured Concentration of BI 1323495 in Plasma (Cmax)
Time frame: 1 hour (h) before drug administration and 1, 2, 3, 4, 6, 7, 8, 9, 10, 12, 24, 34, 48, 72 and 96 h and additionally 4.75, 5.5, 6.5, 7.5 h for dose group 1/2/3 and 0.333, 0.667, 1.5, 5 h for dose group 4/5/6/7/8 after drug administration.

Results and safety

Results posted to the registry on 22 Feb 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 BI 1323495	15	15
BI 1323495 Dose Group 1	6	6
BI 1323495 Dose Group 2	6	6
BI 1323495 Dose Group 3	6	6
BI 1323495 Dose Group 4	6	6
BI 1323495 Dose Group 5	6	6
BI 1323495 Dose Group 6	6	6
BI 1323495 Dose Group 7	6	6
BI 1323495 Dose Group 8	6	6

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

Time frame: From drug administration until end of trial, up to 15 days.. Number. Unit: Percentage of participants

Measure	Placebo Matching BI 1323495 n = 15	BI 1323495 Dose Group 1 n = 6	BI 1323495 Dose Group 2 n = 6	BI 1323495 Dose Group 3 n = 6	BI 1323495 Dose Group 4 n = 6	BI 1323495 Dose Group 5 n = 6	BI 1323495 Dose Group 6 n = 6	BI 1323495 Dose Group 7 n = 6	BI 1323495 Dose Group 8 n = 6
Value	6.7	50.0	33.3	0.0	16.7	0.0	16.7	50.0	16.7

Population analysed: Treated set (TS): This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, as well as for the description of biomarkers.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From drug administration until end of trial, up to 15 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Matching BI 1323495	0 of 15 (0%)	2 of 15 (13.3%)	0 of 15
BI 1323495 Dose Group 1	0 of 6 (0%)	3 of 6 (50%)	0 of 6
BI 1323495 Dose Group 2	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
BI 1323495 Dose Group 3	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
BI 1323495 Dose Group 4	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
BI 1323495 Dose Group 5	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
BI 1323495 Dose Group 6	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
BI 1323495 Dose Group 7	0 of 6 (0%)	3 of 6 (50%)	0 of 6
BI 1323495 Dose Group 8	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
BI 1323495 Total	0 of 48 (0%)	16 of 48 (33.3%)	0 of 48

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Undecided. 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, except for the following exclusions: 1. Studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. Studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). Requestors can use the following link http:// trials.boehringer-ingelheim.com/ to: 1. find information in order to request access to clinical study data, for listed studies. 2. request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement.

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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.

The record lists no contact. Use the official record to reach the sponsor.

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 1323495 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 28 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 22 Feb 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. 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 22 Feb 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 Participants With Drug-related Adverse Events (time frame: From drug administration until end of trial, up to 15 days.). 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 NCT03588390.

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 22 Feb 2024; AzTrials last refreshed its copy on 2 Nov 2026.