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出境医 / 临床实验 / A Study to Test How Well Healthy Men Tolerate Different Doses of BI 706321

A Study to Test How Well Healthy Men Tolerate Different Doses of BI 706321

Study Description
Brief Summary:

The main objectives are:

  • Part I: To investigate safety, tolerability, and pharmacokinetics (PK) of BI 706321 in healthy male subjects following oral administration of single rising doses.
  • Part II: The relative bioavailability of BI 706321 after administration of tablets and capsules under fasted conditions will be compared with each other and the effect of food on the tablet bioavailability will be investigated.

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 706321 Drug: Placebo Phase 1

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 706321 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)
Actual Study Start Date : June 18, 2019
Actual Primary Completion Date : December 4, 2020
Actual Study Completion Date : December 4, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: BI 706321 Drug: BI 706321
Capsule or Oral Solution

Placebo Comparator: Placebo Drug: Placebo
Capsule or Oral solution

Outcome Measures
Primary Outcome Measures :
  1. Part I: Safety and tolerability of BI 706321 is the percentage of subjects with drug-related adverse events [ Time Frame: Up to 22 Days ]
  2. Part II: AUC0-tz (area under the concentration-time curve of BI 706321 in plasma over the time interval from 0 to the last quantifiable data point) [ Time Frame: Up to 22 Days ]
  3. Part II: Cmax (maximum measured concentration of BI 706321 in plasma) [ Time Frame: Up to 22 Days ]

Secondary Outcome Measures :
  1. Part I: AUC0-∞ (area under the concentration-time curve of BI 706321 in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: Up to 22 Days ]
  2. Part I: Cmax (maximum measured concentration of BI 706321 in plasma) [ Time Frame: Up to 22 Days ]
  3. Part I: tmax (time from dosing to the maximum measured concentration of BI 706321 in plasma) [ Time Frame: Up to 22 Days ]
  4. Part II: AUC0-∞ (area under the concentration-time curve of BI 706321 in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: Up to 22 Days ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR, oral body temperature), 12-lead ECG, and clinical laboratory tests
  • Age of 18 to 45 years (inclusive) in Part I and of 18 to 55 years (inclusive) in Part II
  • BMI of 18.5 to 29.9 kg/m2 (inclusive)
  • Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation

Exclusion Criteria:

  • Any finding in the medical examination (including Blood Pressure (BP), (PR), oral body temperature or ECG) deviating from normal and assessed 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 assessed as clinically relevant by the investigator
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or 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 of planned administration of trial medication that might reasonably influence the results of the trial (including drugs that cause QT/QTc interval prolongation)
  • Intake of an investigational drug in another clinical trial within 60 days of planned administration of investigational drug in the current trial, or concurrent participation in another clinical trial in which investigational drug is administered
  • 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 24 g per day)
  • Drug abuse or positive drug screening
  • Blood donation of more than 100 mL within 30 days of planned administration of trial medication or intended blood donation during the trial
  • Intention to perform excessive physical activities within one week prior to the administration of trial medication or during the trial
  • Inability to comply with the dietary regimen of the 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 Torsade 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 the subject is not considered able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
  • Male subjects with WOCBP partner who are unwilling to use male contraception (condom or sexual abstinence) from time point of administration of trial medication until 30 days thereafter. Sperm donation is not allowed from the time point of drug administration until 30 days thereafter.
  • ALT (alanine transaminase), AST (aspartate transaminase), or creatinine exceed upper limit of normal range at screening, confirmed by a repeat test
  • During COVID-19 pandemic: laboratory test indicative of an ongoing SARS-CoV-2 infection
Contacts and Locations

Locations
Layout table for location information
Germany
Humanpharmakologisches Zentrum Biberach
Biberach, Germany, 88397
Sponsors and Collaborators
Boehringer Ingelheim
Tracking Information
First Submitted Date  ICMJE May 31, 2019
First Posted Date  ICMJE June 3, 2019
Last Update Posted Date December 10, 2020
Actual Study Start Date  ICMJE June 18, 2019
Actual Primary Completion Date December 4, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2020)
  • Part I: Safety and tolerability of BI 706321 is the percentage of subjects with drug-related adverse events [ Time Frame: Up to 22 Days ]
  • Part II: AUC0-tz (area under the concentration-time curve of BI 706321 in plasma over the time interval from 0 to the last quantifiable data point) [ Time Frame: Up to 22 Days ]
  • Part II: Cmax (maximum measured concentration of BI 706321 in plasma) [ Time Frame: Up to 22 Days ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
Safety and tolerability of BI 706321 is the percentage of subjects with drug-related adverse events. [ Time Frame: Up to 22 Days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2020)
  • Part I: AUC0-∞ (area under the concentration-time curve of BI 706321 in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: Up to 22 Days ]
  • Part I: Cmax (maximum measured concentration of BI 706321 in plasma) [ Time Frame: Up to 22 Days ]
  • Part I: tmax (time from dosing to the maximum measured concentration of BI 706321 in plasma) [ Time Frame: Up to 22 Days ]
  • Part II: AUC0-∞ (area under the concentration-time curve of BI 706321 in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: Up to 22 Days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
  • AUC0-∞ (area under the concentration-time curve of BI 706321 in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: Up to 22 Days ]
  • Cmax (maximum measured concentration of BI 706321 in plasma) [ Time Frame: Up to 22 Days ]
  • tmax (time from dosing to the maximum measured concentration of BI 706321 in plasma) [ Time Frame: Up to 22 Days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Test How Well Healthy Men Tolerate Different Doses of BI 706321
Official Title  ICMJE Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 706321 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)
Brief Summary

The main objectives are:

  • Part I: To investigate safety, tolerability, and pharmacokinetics (PK) of BI 706321 in healthy male subjects following oral administration of single rising doses.
  • Part II: The relative bioavailability of BI 706321 after administration of tablets and capsules under fasted conditions will be compared with each other and the effect of food on the tablet bioavailability will be investigated.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: BI 706321
    Capsule or Oral Solution
  • Drug: Placebo
    Capsule or Oral solution
Study Arms  ICMJE
  • Experimental: BI 706321
    Intervention: Drug: BI 706321
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2020)
61
Original Estimated Enrollment  ICMJE
 (submitted: May 31, 2019)
80
Actual Study Completion Date  ICMJE December 4, 2020
Actual Primary Completion Date December 4, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR, oral body temperature), 12-lead ECG, and clinical laboratory tests
  • Age of 18 to 45 years (inclusive) in Part I and of 18 to 55 years (inclusive) in Part II
  • BMI of 18.5 to 29.9 kg/m2 (inclusive)
  • Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation

Exclusion Criteria:

  • Any finding in the medical examination (including Blood Pressure (BP), (PR), oral body temperature or ECG) deviating from normal and assessed 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 assessed as clinically relevant by the investigator
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or 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 of planned administration of trial medication that might reasonably influence the results of the trial (including drugs that cause QT/QTc interval prolongation)
  • Intake of an investigational drug in another clinical trial within 60 days of planned administration of investigational drug in the current trial, or concurrent participation in another clinical trial in which investigational drug is administered
  • 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 24 g per day)
  • Drug abuse or positive drug screening
  • Blood donation of more than 100 mL within 30 days of planned administration of trial medication or intended blood donation during the trial
  • Intention to perform excessive physical activities within one week prior to the administration of trial medication or during the trial
  • Inability to comply with the dietary regimen of the 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 Torsade 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 the subject is not considered able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
  • Male subjects with WOCBP partner who are unwilling to use male contraception (condom or sexual abstinence) from time point of administration of trial medication until 30 days thereafter. Sperm donation is not allowed from the time point of drug administration until 30 days thereafter.
  • ALT (alanine transaminase), AST (aspartate transaminase), or creatinine exceed upper limit of normal range at screening, confirmed by a repeat test
  • During COVID-19 pandemic: laboratory test indicative of an ongoing SARS-CoV-2 infection
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03971695
Other Study ID Numbers  ICMJE 1425-0001
2019-000888-25 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description:

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). For more details refer to: http://trials.boehringer-ingelheim.com/

Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP