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CompletedNCT03588390Updated Feb 22, 2024Results posted

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 interventional study of BI 1323495 and BI 1323495 in Healthy, sponsored by Boehringer Ingelheim. Completed at 1 site in Germany. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-22.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study 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 after single dosing and the assessment of the PK/PD relationship.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
  • 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
63 participants (actual)

Study arms

  • Experimental
    Dose Group 1

    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.

    Drug: BI 1323495 · Drug: Placebo

  • Experimental
    Dose Group 2

    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.

    Drug: BI 1323495 · Drug: Placebo

  • Experimental
    Dose Group 3

    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.

    Drug: BI 1323495 · Drug: Placebo

  • Experimental
    Dose Group 4

    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.

    Drug: BI 1323495 · Drug: Placebo

  • Experimental
    Dose Group 5

    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.

    Drug: BI 1323495 · Drug: Placebo

  • Experimental
    Dose Group 6

    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.

    Drug: BI 1323495 · Drug: Placebo

  • Experimental
    Dose Group 7

    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.

    Drug: BI 1323495 · Drug: Placebo

  • Experimental
    Dose Group 8

    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.

    Drug: BI 1323495 · Drug: Placebo

Interventions

  • DrugBI 1323495

    Low strength tablet

  • DrugBI 1323495

    Middle strength tablet

  • DrugBI 1323495

    High strength tablet

  • DrugPlacebo

    Placebo to low strength tablet

  • DrugPlacebo

    Placebo to middle strength tablet

  • DrugPlacebo

    Placebo to high strength tablet

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With Drug-related Adverse Events

    Percentage of participants with drug-related adverse events.

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

Secondary outcomes

  1. 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.

    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.

  2. 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.

    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.

07

Results

Posted Feb 22, 2024

Participant flow

This single-rising dose trial was designed as single-blind, partially randomised, and placebo-controlled within parallel dose groups.

Participant flow — Overall Study
MilestonePlacebo Matching BI 1323495BI 1323495 Dose Group 1BI 1323495 Dose Group 2BI 1323495 Dose Group 3BI 1323495 Dose Group 4BI 1323495 Dose Group 5BI 1323495 Dose Group 6BI 1323495 Dose Group 7BI 1323495 Dose Group 8
Started1566666666
Completed1566666666
Not completed000000000

Outcome measures

PrimaryPercentage of Participants With Drug-related Adverse Events

Percentage of participants with drug-related adverse events.

Time frame:
From drug administration until end of trial, up to 15 days.
Reported as:
Number · Percentage of participants
Percentage of Participants With Drug-related Adverse Events
Percentage of participantsPlacebo Matching BI 1323495BI 1323495 Dose Group 1BI 1323495 Dose Group 2BI 1323495 Dose Group 3BI 1323495 Dose Group 4BI 1323495 Dose Group 5BI 1323495 Dose Group 6BI 1323495 Dose Group 7BI 1323495 Dose Group 8
Percentage of Participants With Drug-related Adverse Events6.750.033.30.016.70.016.750.016.7
SecondaryArea 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.

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.
Reported as:
Geometric mean · nanomole (nmol)*hours (h) /Liter (L)
Area Under the Concentration-time Curve of BI 1323495 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
nanomole (nmol)*hours (h) /Liter (L)BI 1323495 Dose Group 1BI 1323495 Dose Group 2BI 1323495 Dose Group 3BI 1323495 Dose Group 4BI 1323495 Dose Group 5BI 1323495 Dose Group 6BI 1323495 Dose Group 7BI 1323495 Dose Group 8
Area Under the Concentration-time Curve of BI 1323495 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)143 ± 102.0883 ± 118.0824 ± 77.72360 ± 73.53710 ± 69.43120 ± 140.01780 ± 102.03820 ± 71.9
Statistical analysis
  • BI 1323495 Dose Group 1 vs BI 1323495 Dose Group 2 vs BI 1323495 Dose Group 3 vs BI 1323495 Dose Group 4 vs BI 1323495 Dose Group 5 vs BI 1323495 Dose Group 6 vs BI 1323495 Dose Group 7 vs BI 1323495 Dose Group 8 · Slope: 0.6960 · 95% CI 0.5006 to 0.8914Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of the mean is actually standard error of slope.
  • BI 1323495 Dose Group 1 vs BI 1323495 Dose Group 2 vs BI 1323495 Dose Group 3 vs BI 1323495 Dose Group 4 vs BI 1323495 Dose Group 5 vs BI 1323495 Dose Group 6 · Slope: 0.9244 · 95% CI 0.6764 to 1.1724Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of the mean is actually standard error of slope.
SecondaryMaximum Measured Concentration of BI 1323495 in Plasma (Cmax)

Maximum measured concentration of BI 1323495 in plasma (Cmax) after single oral administration of BI 1323495.

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.
Reported as:
Geometric mean · nmol/L
Maximum Measured Concentration of BI 1323495 in Plasma (Cmax)
nmol/LBI 1323495 Dose Group 1BI 1323495 Dose Group 2BI 1323495 Dose Group 3BI 1323495 Dose Group 4BI 1323495 Dose Group 5BI 1323495 Dose Group 6BI 1323495 Dose Group 7BI 1323495 Dose Group 8
Maximum Measured Concentration of BI 1323495 in Plasma (Cmax)10.5 ± 66.359.4 ± 147.0145.0 ± 74.8229.0 ± 127.0179.0 ± 152.0136.0 ± 74.2195.0 ± 90.8195.0 ± 90.8
Statistical analysis
  • BI 1323495 Dose Group 1 vs BI 1323495 Dose Group 2 vs BI 1323495 Dose Group 3 vs BI 1323495 Dose Group 4 vs BI 1323495 Dose Group 5 vs BI 1323495 Dose Group 6 vs BI 1323495 Dose Group 7 vs BI 1323495 Dose Group 8 · Slope: 0.6533 · 95% CI 0.4556 to 0.8510Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of the mean is actually standard error of slope.
  • BI 1323495 Dose Group 1 vs BI 1323495 Dose Group 2 vs BI 1323495 Dose Group 3 vs BI 1323495 Dose Group 4 vs BI 1323495 Dose Group 5 vs BI 1323495 Dose Group 6 · Slope: 0.8586 · 95% CI 0.5929 to 1.1242Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of the mean is actually standard error of slope.

Adverse events

Collected over From drug administration until end of trial, up to 15 days.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo Matching BI 13234950/15 (0%)0/15 (0%)2/15 (13.3%)
BI 1323495 Dose Group 10/6 (0%)0/6 (0%)3/6 (50%)
BI 1323495 Dose Group 20/6 (0%)0/6 (0%)2/6 (33.3%)
BI 1323495 Dose Group 30/6 (0%)0/6 (0%)1/6 (16.7%)
BI 1323495 Dose Group 40/6 (0%)0/6 (0%)2/6 (33.3%)
BI 1323495 Dose Group 50/6 (0%)0/6 (0%)1/6 (16.7%)
BI 1323495 Dose Group 60/6 (0%)0/6 (0%)2/6 (33.3%)
BI 1323495 Dose Group 70/6 (0%)0/6 (0%)3/6 (50%)
BI 1323495 Dose Group 80/6 (0%)0/6 (0%)2/6 (33.3%)
BI 1323495 Total0/48 (0%)0/48 (0%)16/48 (33.3%)
Most frequent other events
Most frequent other events
EventPlacebo Matching BI 1323495BI 1323495 Dose Group 1BI 1323495 Dose Group 2BI 1323495 Dose Group 3BI 1323495 Dose Group 4BI 1323495 Dose Group 5BI 1323495 Dose Group 6BI 1323495 Dose Group 7BI 1323495 Dose Group 8BI 1323495 Total
HeadacheNervous system disorders2/153/61/60/60/60/60/61/61/66/48
DiarrhoeaGastrointestinal disorders0/150/61/60/60/60/60/61/60/62/48
FatigueGeneral disorders0/150/60/61/61/60/60/60/60/62/48
MalaiseGeneral disorders0/150/60/60/60/61/60/60/60/61/48
Unevaluable eventGeneral disorders0/150/60/60/60/60/60/61/60/61/48
NasopharyngitisInfections and infestations0/150/60/60/60/60/61/60/60/61/48
RhinitisInfections and infestations0/150/60/60/60/60/60/60/61/61/48
Alanine aminotransferase increasedInvestigations0/150/60/60/60/60/61/60/60/61/48
Glutamate dehydrogenase increasedInvestigations0/150/60/60/60/60/61/60/60/61/48
Musculoskeletal stiffnessMusculoskeletal and connective tissue disorders0/150/60/60/61/60/60/60/60/61/48

Baseline characteristics

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.

Age, Continuous
Age, Continuous(Years)Placebo Matching BI 1323495BI 1323495 Dose Group 1BI 1323495 Dose Group 2BI 1323495 Dose Group 3BI 1323495 Dose Group 4BI 1323495 Dose Group 5BI 1323495 Dose Group 6BI 1323495 Dose Group 7BI 1323495 Dose Group 8Total
Mean28.9 ± 6.028.0 ± 7.631.5 ± 6.429.8 ± 8.934.3 ± 5.433.7 ± 8.634.3 ± 6.530.8 ± 4.129.5 ± 5.230.9 ± 6.6
Sex: Female, Male
Sex: Female, Male(Participants)Placebo Matching BI 1323495BI 1323495 Dose Group 1BI 1323495 Dose Group 2BI 1323495 Dose Group 3BI 1323495 Dose Group 4BI 1323495 Dose Group 5BI 1323495 Dose Group 6BI 1323495 Dose Group 7BI 1323495 Dose Group 8Total
Female0000000000
Male156666666663
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Placebo Matching BI 1323495BI 1323495 Dose Group 1BI 1323495 Dose Group 2BI 1323495 Dose Group 3BI 1323495 Dose Group 4BI 1323495 Dose Group 5BI 1323495 Dose Group 6BI 1323495 Dose Group 7BI 1323495 Dose Group 8Total
Hispanic or Latino0000000000
Not Hispanic or Latino156666666663
Unknown or Not Reported0000000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Placebo Matching BI 1323495BI 1323495 Dose Group 1BI 1323495 Dose Group 2BI 1323495 Dose Group 3BI 1323495 Dose Group 4BI 1323495 Dose Group 5BI 1323495 Dose Group 6BI 1323495 Dose Group 7BI 1323495 Dose Group 8Total
American Indian or Alaska Native0000000000
Asian0000000000
Native Hawaiian or Other Pacific Islander0000000000
Black or African American0000000000
White156666666663
More than one race0000000000
Unknown or Not Reported0000000000
08

Study locations

1 site
  • Humanpharmakologisches Zentrum Biberach
    Biberach, 88397, Germany
09

References and documents

Related links

Study documents

  • Study protocol · Aug 28, 2018
  • Statistical analysis plan · Jan 10, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03588390
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Jul 17, 2018
Start date
Jul 31, 2018
Primary completion
Nov 14, 2018
Completion
Nov 14, 2018
Results posted
Feb 22, 2024
Last update
Feb 22, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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