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Single Rising Dose Study of BI 690517 in Healthy Volunteers

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: NCT02891148
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE September 1, 2016
First Posted Date  ICMJE September 7, 2016
Last Update Posted Date April 4, 2018
Actual Study Start Date  ICMJE September 29, 2016
Actual Primary Completion Date December 12, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2018)
The percentage of subjects with adverse reactions, analysed as investigator defined drug-related adverse events. [ Time Frame: From the first drug administration until end of the trial, up to 14 days ]
The percentage of subjects with adverse reactions, analysed as investigator defined drug-related adverse events (AEs).
Original Primary Outcome Measures  ICMJE
 (submitted: September 1, 2016)
Number of subjects (%) with drug related adverse events (AEs) [ Time Frame: up to 336 hours ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2018)
  • Area under the concentration-time curve of the BI-690517 in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity) [ Time Frame: Pharmacokinetic blood samples: 1:30 hours before drug administration and 30 minutes, 1, 1:30, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 hours after drug administration. ]
    Area under the concentration-time curve of the BI-690517 in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity).
  • Maximum measured concentration of the BI-690517 in plasma (Cmax) [ Time Frame: PK blood samples: 1:30 hours before drug administration and 30 minutes, 1, 1:30, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 hours after drug administration. ]
    Maximum measured concentration of the BI-690517 in plasma (Cmax).
Original Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2016)
  • AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 48 hours ]
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 48 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single Rising Dose Study of BI 690517 in Healthy Volunteers
Official Title  ICMJE Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 690517 in Healthy Male Subjects
Brief Summary To investigate safety, tolerability, pharmacokinetics and pharmacodynamics following single rising doses of BI 690517
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Drug: BI 690517
Study Arms  ICMJE Experimental: BI 690517
Intervention: Drug: BI 690517
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: January 23, 2017)
50
Original Estimated Enrollment  ICMJE
 (submitted: September 1, 2016)
56
Actual Study Completion Date  ICMJE December 12, 2016
Actual Primary Completion Date December 12, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Healthy male subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests
  • Age of 18 to 50 years (incl.)
  • 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 and local legislation

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 100 to 140 mmHg, diastolic blood pressure outside the range of 60 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 for males)
  • 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 in males) 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
  • Values for serum sodium and potassium outside normal range at screening
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE Child, Adult, Older 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 NCT02891148
Other Study ID Numbers  ICMJE 1378.1
2015-003642-10 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date April 2018

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