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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)

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02202512
Enrollment
53
Registered
2014-07-29
Start date
2014-09-30
Completion date
2014-12-31
Last updated
2014-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGPlacebo

tablets

DRUGCimetidine
DRUGBI 1060469 high dose

tablets

DRUGBI 1060469 low dose

tablets

DRUGNaproxen
DRUGBI 1021958

tablets

Sponsors

Boehringer Ingelheim
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
measured glomerular filtration rate (mGFR) based on renal iohexol clearanceup to day 11

Secondary

MeasureTime frame
measured urinary 24-hour creatinine clearanceup to day 11

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026