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Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1060469 in Healthy Asian Male 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: NCT02183545
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : October 16, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The objective of this single rising dose study (SRD) is to investigate safety, tolerability, and pharmacokinetics of single rising doses of BI 1060469 in healthy Asian male subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 1060469 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1060469 in Healthy Asian Male Volunteers in a Randomized, Double-blind, Placebo-controlled Design
Study Start Date : July 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Arm Intervention/treatment
Experimental: BI 1060469
single rising doses given as tablet
Drug: BI 1060469
single rising doses given as tablet

Placebo Comparator: Placebo
given as tablet (matching placebo of BI 1060469)
Drug: Placebo
given as tablet (matching placebo of BI 1060469)




Primary Outcome Measures :
  1. number of subjects with drug-related adverse events [ Time Frame: up to 14 days after drug administration ]

Secondary Outcome Measures :
  1. Maximum concentration of BI 1060469 (Cmax) [ Time Frame: up to 72 hours after drug administration ]
  2. Area Under the concentration-time curve of BI 1060469 over time interval from 0 interpolated to infinity ((AUC0-infinity) [ Time Frame: up to 72 hours after drug administration ]
  3. Area Under the concentration-time curve of BI 1060469 (AUC0- tz) [ Time Frame: up to 72 hours after drug administration ]


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:

  1. Healthy males based upon a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead ECG, and clinical laboratory tests
  2. Chinese ethnicity, Japanese ethnicity according to the following criteria:

    Chinese; born in China or ethnic Chinese born outside of China, and a descendent of 4 ethnic Chinese grandparents who were all born in china Japanese; born in Japan, have lived outside of Japan <10 years, and have parents and grandparents who were all born in Japan

  3. Age within the range of 18 to 45 years
  4. Body mass index within the range of 18.5 and 25 kg/m2
  5. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice(GCP) and local legislation.

Exclusion criteria:

  1. Any finding in the medical examination (including blood pressure, pulse rate or ECG(electrocardiogram)) deviating from normal and judged clinically relevant by the investigator. Pulse rate outside the range of 50-90 beat per minute or blood pressure outside the ranges of 90-140 for systolic and 50-90 mmHg for diastolic blood pressure if confirmed by repeat measurement.
  2. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  3. Serum creatinine laboratory value outside the normal range
  4. Glomerular Filtration Rate according to CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) Formula < 60 ml/ min
  5. Current or history of relevant kidney, urinary tract diseases or abnormalities (i.e. nephrolithiasis, hydronephrosis, acute or chronic nephritis, renal injury, renal failure, infections)
  6. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  7. Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug
  8. Diseases of the central nervous system (such as epilepsy), central neurological disorders or psychiatric disorders
  9. History of relevant orthostatic hypotension, fainting spells, or blackouts
  10. Relevant chronic or acute infections
  11. History of relevant allergy/hypersensitivity (including allergy to the trial medication or its excipients)
  12. Intake of drugs with a long half-life (greater than 24 hours) within 30 days or less than 10 half-lives of the respective drug prior to study drug administration
  13. Intake of any NSAIDs(Nonsteroidal anti-inflammatory drugs), COX2(Cyclooxygenase-2) inhibitors, aspirin, ACE(Angiotensin Converting Enzyme) inhibitors, H2-blockers or OTC(Over the Counter Drug)- or nutripharmaceuticals between screening examination and drug administration
  14. Use of drugs that might reasonably influence the results of the trial (including renal function measurements) or that might prolong the QT/QTc interval within 14 days prior to study drug administration
  15. Participation in another trial with investigational drug administration within 60 days prior to administration of trial medication
  16. Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
  17. Inability to refrain from smoking on specified trial days
  18. Alcohol abuse (consumption of more than 30 g/day)
  19. Drug abuse or positive drug screen
  20. Blood donation (more than 100 mL within 30 days prior to administration of trial medication or intended during the trial)
  21. Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial
  22. Inability to comply with dietary regimen of trial site
  23. A marked baseline prolongation of QT/QTc interval (such as repeated demonstration of a QTc interval greater than 450 ms) or any other relevant ECG finding
  24. A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)
  25. Subject is assessed by the investigator as unsuitable for inclusion, 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

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): NCT02183545


Locations
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Korea, Republic of
1333.3.82002 Boehringer Ingelheim Investigational Site
Busan, Korea, Republic of
1333.3.82001 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02183545    
Other Study ID Numbers: 1333.3
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: October 16, 2014
Last Verified: October 2014