Effect of Repeated Doses of BI 1060469 and BI 1021958 on Glomerular Filtration Rate (GFR) in Healthy Volunteers
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)
2 other identifiers
interventional
53
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Sep 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2014
CompletedFirst Posted
Study publicly available on registry
July 29, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedDecember 24, 2014
December 1, 2014
3 months
July 28, 2014
December 23, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
measured glomerular filtration rate (mGFR) based on renal iohexol clearance
up to day 11
Secondary Outcomes (1)
measured urinary 24-hour creatinine clearance
up to day 11
Study Arms (5)
BI 1060469 low dose
EXPERIMENTALLow-Dose,Tablet,oral administration with 240 ml water,over 10 days
BI 1060469 high dose
EXPERIMENTALHigh-Dose,Tablets,oral administration with 240 ml water, over 10 days
Cimetidine
ACTIVE COMPARATORNaproxen
ACTIVE COMPARATORBI 1021958
EXPERIMENTALHigh-Dose,Tablets,oral administration with 240 ml water, over 10 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
1333.43.1 Boehringer Ingelheim Investigational Site
Berlin, Germany
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2014
First Posted
July 29, 2014
Study Start
September 1, 2014
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
December 24, 2014
Record last verified: 2014-12