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Effect of Repeated Doses of BI 1060469 and BI 1021958 on Glomerular Filtration Rate (GFR) in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02202512
Recruitment Status : Completed
First Posted : July 29, 2014
Last Update Posted : December 24, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief Summary:

Main objective is to investigate the measured glomerular filtration rate (mGFR) as assessed by iohexol clearance in healthy male normovolemic subjects after oral administration of single and repeated doses of BI 1060469, and BI 1021958.

The secondary objective of this trial is to investigate the glomerular filtration rate (GFR) as assessed by 24 hours creatinine clearance in healthy male normovolemic subjects after oral administration of single and repeated doses of BI 1060469, and BI 1021958.


Condition or disease Intervention/treatment Phase
Healthy Drug: Placebo Drug: Cimetidine Drug: BI 1060469 high dose Drug: BI 1060469 low dose Drug: Naproxen Drug: BI 1021958 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Effect of Repeated Oral Doses of BI 1060469, BI 1021958 and Active Controls, Cimetidine and Naproxen, on Measured GFR Via Renal Clearance of Iohexol in Healthy Male Subjects (a Phase I Study; Single-blind, Randomized, Placebo-controlled Within BI Groups and Open-label for the Active Controls)
Study Start Date : September 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Cimetidine

Arms and Interventions
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Arm Intervention/treatment
Experimental: BI 1060469 low dose
Low-Dose,Tablet,oral administration with 240 ml water,over 10 days
 Drug: Placebo
tablets

Drug: BI 1060469 low dose
tablets
Experimental: BI 1060469 high dose
High-Dose,Tablets,oral administration with 240 ml water, over 10 days
 Drug: Placebo
tablets

Drug: BI 1060469 high dose
tablets
Active Comparator: Cimetidine Drug: Cimetidine
Active Comparator: Naproxen Drug: Naproxen
Experimental: BI 1021958
High-Dose,Tablets,oral administration with 240 ml water, over 10 days
 Drug: Placebo
tablets

Drug: BI 1021958
tablets


Outcome Measures
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Primary Outcome Measures :
  1. measured glomerular filtration rate (mGFR) based on renal iohexol clearance [ Time Frame: up to day 11 ]

Secondary Outcome Measures :
  1. measured urinary 24-hour creatinine clearance [ Time Frame: up to day 11 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Healthy male subjects according to the investigators assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests, including negative test result on occult blood in stool (only for subjects assigned to Naproxen)
  • Age 18 to 45 years (incl.)
  • Body Mass Index (BMI) 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 (GCP) and local legislation

Exclusion criteria:

  • Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator
  • Repeated measurement of systolic blood pressure greater than 140 mm Hg, diastolic blood pressure greater than 90 mm Hg, or pulse rate outside the range of 50 to 90 mmHg
  • Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  • Serum creatinine laboratory value out of the normal range
  • GFR (Glomerular Filtration Rate) < 90 mL/ min at screening
  • Urinary toral protein/creatinine ratio > 0,1 mg protein/ mg creatinine
  • Current or history of relevant kidney, urinary tract diseases or abnormalities (i.e. nephrolithiasis, hydronephrosis, acute or chronic nephritis, renal injury, renal failure, infections)
  • Further exclusion criteria may apply
Contacts and Locations
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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): NCT02202512


Locations
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Germany
1333.43.1 Boehringer Ingelheim Investigational Site
Berlin, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02202512    
Other Study ID Numbers: 1333.43
2014-000320-20 ( EudraCT Number: EudraCT )
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: December 24, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Naproxen
Cimetidine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
 Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors