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Evaluation of Safety and Tolerability of Single Rising Doses of BI 473494 in Healthy Subjects

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: NCT03195088
Recruitment Status : Terminated (Terminated (Business Reasons))
First Posted : June 22, 2017
Results First Posted : June 22, 2022
Last Update Posted : June 22, 2022
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:

The primary objective of this trial is to investigate the safety and tolerability of single rising doses of BI 473494 in healthy male subjects.

The secondary objective is the exploration of PK including dose proportionality, and PD of BI 473494 after single dosing.


Condition or disease Intervention/treatment Phase
Healthy Drug: BI 473494 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Subcutaneous Doses of BI 473494 in Healthy Male Subjects (Single-blind, Partially Randomised, Placebo-controlled Parallel Group Design)
Actual Study Start Date : July 27, 2017
Actual Primary Completion Date : November 14, 2017
Actual Study Completion Date : November 14, 2017

Arm Intervention/treatment
Placebo Comparator: Placebo
Healthy participants were administered a single dose of placebo matching BI 473494 solution via subcutaneous injection.
Drug: Placebo
Solution for injection

Experimental: BI 473494 35 μg
Healthy participants were administered a single dose of 35 micrograms (μg) BI 473494 solution via subcutaneous injection.
Drug: BI 473494
Solution for injection

Experimental: BI 473494 75 μg
Healthy participants were administered a single dose of 75 micrograms (μg) BI 473494 solution via subcutaneous injection.
Drug: BI 473494
Solution for injection




Primary Outcome Measures :
  1. Percentage of Participants With Drug-related Adverse Events (AEs) Analysed as Investigator Defined Drug-related AEs [ Time Frame: From first drug administration until End of trial (EOT) after last drug administration, up to 40 days. ]
    Percentage of participants with drug-related adverse events (AEs) analysed as investigator defined drug-related AEs is presented.


Secondary Outcome Measures :
  1. Area Under the Concentration-time Curve of BI 473494 Over the Time Interval From 0 to the Last Quantifiable Time Point (AUC0-tz) [ Time Frame: Pharmacokinetic samples were taken 1:00 hour:minute (h:m) pre-dose and 3:00, 6:00, 9:00, 12:00, 15:00 , 22:00, 24:00, 28:00, 34:00, 39:00, 48:00, 60:00, 72:00, 96:00, 120:00, 168:00, 240:00, 336:00, 504:00 and 672:00 h:m after drug administration on day 1 ]
    AUC0-tz, area under the concentration-time curve of BI 473494 over the time interval from 0 to the last quantifiable time point is presented.

  2. Maximum Measured Concentration of BI 473494 (Cmax) [ Time Frame: Pharmacokinetic samples were taken 1:00 hour:minute (h:m) pre-dose and 3:00, 6:00, 9:00, 12:00, 15:00 , 22:00, 24:00, 28:00, 34:00, 39:00, 48:00, 60:00, 72:00, 96:00, 120:00, 168:00, 240:00, 336:00, 504:00 and 672:00 h:m after drug administration on day 1 ]
    Cmax, maximum measured concentration of BI 473494 is presented.



Information from the National Library of Medicine

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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, 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 20.0 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:

  • 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
  • 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)
  • Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
  • Further exclusion criteria apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195088


Locations
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Germany
CRS Clinical Research Services Mannheim GmbH
Mannheim, Germany, 68167
Sponsors and Collaborators
Boehringer Ingelheim
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:
Study Protocol  [PDF] May 2, 2017
Statistical Analysis Plan  [PDF] January 29, 2019

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03195088    
Other Study ID Numbers: 1400-0001
2016-003224-24 ( EudraCT Number )
First Posted: June 22, 2017    Key Record Dates
Results First Posted: June 22, 2022
Last Update Posted: June 22, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No