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This Study Tests How Healthy Men Tolerate Different Doses of BI 730357 and How the Metabolism of Midazolam is Affected by BI 730357

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03279978
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE September 11, 2017
First Posted Date  ICMJE September 12, 2017
Last Update Posted Date November 7, 2018
Actual Study Start Date  ICMJE January 9, 2018
Actual Primary Completion Date August 24, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2017)
Number of subjects with drug-related Adverse Events (AEs) [ Time Frame: up to 5 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 11, 2017)
  • Part 1: Number of subjects with drug-related Adverse Events (AEs) [ Time Frame: up to 5 weeks ]
  • Part 2: Achievement of ≥ 75% reduction from baseline Psoriasis Area and Severity Index (PASI) score (PASI 75) [ Time Frame: Baseline and Week 12 ]
  • Part 2: Achievement of an Static Physician Global Assessment (sPGA) score of clear or almost clear [ Time Frame: Week 12 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2017)
  • AUCtau,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval tau after administration of the first dose) [ Time Frame: Week 4 ]
  • After the first dose: Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: Week 4 ]
  • After the last dose: AUCtau,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval tau) [ Time Frame: Week 4 ]
  • After the last dose:Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval tau) [ Time Frame: Week 4 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2017)
  • Part 1:AUCtau,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval tau after administration of the first dose) [ Time Frame: Week 4 ]
  • Part 1: After the first dose: Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: Week 4 ]
  • Part 1: After the last dose: AUCtau,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval tau) [ Time Frame: Week 4 ]
  • Part 1: After the last dose:Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval tau) [ Time Frame: Week 4 ]
  • Part 2: Achievement of ≥50% reduction from baseline in Psoriasis Area and Severity Index (PASI) score (Psoriasis Area and Severity Index (PASI) 50) [ Time Frame: Week 12 ]
  • Part 2: Achievement of ≥90% reduction from baseline in Psoriasis Area and Severity Index (PASI) score (Psoriasis Area and Severity Index (PASI) 90) [ Time Frame: Week 12 ]
  • Part 2: Achievement of 100% reduction from baseline in Psoriasis Area and Severity Index (PASI) score (Psoriasis Area and Severity Index (PASI) 100) [ Time Frame: Week 12 ]
  • Part 2: Achievement of Static Physician Global Assessment (sPGA) clear [ Time Frame: Week 12 ]
  • Part 2: Achievement of ≥75% reduction from baseline in Psoriasis Area and Severity Index (PASI) score (Psoriasis Area and Severity Index (PASI) 75) [ Time Frame: Week 16, 20 and 24 ]
  • Part 2: Achievement of an Static Physician Global Assessment (sPGA) score of clear or almost clear [ Time Frame: Week 16, 20 and 24 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE This Study Tests How Healthy Men Tolerate Different Doses of BI 730357 and How the Metabolism of Midazolam is Affected by BI 730357
Official Title  ICMJE Phase Ib Evaluation of the Safety and Tolerability and Effect on Midazolam Metabolism of the Administration of Multiple Rising Doses of BI 730357 to Healthy Volunteers
Brief Summary Phase Ib evaluation of the safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) properties of Multiple Rising Dose (MRD) administration of BI 730357 to healthy volunteers for up to 28 days.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Healthy
  • Psoriasis
Intervention  ICMJE
  • Drug: BI 730357
    up to 28 days
  • Drug: Placebo
    up to 28 days
  • Drug: Midazolam
    Dose groups 4 & 5 only
Study Arms  ICMJE
  • Experimental: BI 730357
    Interventions:
    • Drug: BI 730357
    • Drug: Midazolam
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: Placebo
    • Drug: Midazolam
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: September 5, 2018)
83
Original Estimated Enrollment  ICMJE
 (submitted: September 11, 2017)
240
Actual Study Completion Date  ICMJE August 30, 2018
Actual Primary Completion Date August 24, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male subjects according to the assessment of the Investigator, based on a complete medical history, physical examination, vital signs (blood pressure, pulse rate), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
  • Subjects with a partner who is a woman of childbearing potential (WOCBP) must be willing to use male contraception (condom or sexual abstinence) from the first administration of trial medication until 30 days after last administration of trial medication
  • Age of 18 to 45 years (incl.) at screening
  • Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (incl.) at screening
  • Signed and dated written informed consent prior to admission to the study in accordance with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation

Exclusion criteria

  • Any finding in the medical examination (including blood pressure, pulse rate or Electrocardiogram (ECG)) 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 beats per minute (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 (except appendectomy and simple hernia repair) that could interfere with the PK of the trial medication
  • Diseases of the Central Nervous System (CNS) (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 acute infections which are of relevance in the opinion of the Investigator
  • 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
  • Tobacco usage (more than 10 cigarettes or 3 cigars or 3 pipes per day)
  • 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
  • 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, is considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
  • Unwillingness to adhere to the rules of UV-light protection
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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 NCT03279978
Other Study ID Numbers  ICMJE 1407-0002
2017-001653-14 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date November 2018

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