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

NCT ID: NCT02202512

Last Updated: 2014-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Study Groups

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BI 1060469 low dose

Low-Dose,Tablet,oral administration with 240 ml water,over 10 days

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

tablets

BI 1060469 low dose

Intervention Type DRUG

tablets

BI 1060469 high dose

High-Dose,Tablets,oral administration with 240 ml water, over 10 days

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

tablets

BI 1060469 high dose

Intervention Type DRUG

tablets

Cimetidine

Group Type ACTIVE_COMPARATOR

Cimetidine

Intervention Type DRUG

Naproxen

Group Type ACTIVE_COMPARATOR

Naproxen

Intervention Type DRUG

BI 1021958

High-Dose,Tablets,oral administration with 240 ml water, over 10 days

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

tablets

BI 1021958

Intervention Type DRUG

tablets

Interventions

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Placebo

tablets

Intervention Type DRUG

Cimetidine

Intervention Type DRUG

Placebo

tablets

Intervention Type DRUG

Placebo

tablets

Intervention Type DRUG

BI 1060469 high dose

tablets

Intervention Type DRUG

BI 1060469 low dose

tablets

Intervention Type DRUG

Naproxen

Intervention Type DRUG

BI 1021958

tablets

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1333.43.1 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2014-000320-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1333.43

Identifier Type: -

Identifier Source: org_study_id