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CompletedNCT02202512Updated Dec 24, 2014

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

A Phase 1 interventional study of Placebo and Cimetidine in Healthy, sponsored by Boehringer Ingelheim. Completed at 1 site in Germany. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-12-24.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
53
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Browse Boehringer Ingelheim studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Male
Accepts 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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
53 participants (actual)

Study arms

  • Experimental
    BI 1060469 low dose

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

    Drug: Placebo · Drug: BI 1060469 low dose

  • Experimental
    BI 1060469 high dose

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

    Drug: Placebo · Drug: BI 1060469 high dose

  • 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 · Drug: BI 1021958

Interventions

  • DrugPlacebo

    tablets

  • DrugCimetidine
  • DrugPlacebo

    tablets

  • DrugPlacebo

    tablets

  • DrugBI 1060469 high dose

    tablets

  • DrugBI 1060469 low dose

    tablets

  • DrugNaproxen
  • DrugBI 1021958

    tablets

06

What researchers measure

Primary outcomes

  1. measured glomerular filtration rate (mGFR) based on renal iohexol clearance

    Time frame: up to day 11

Secondary outcomes

  1. measured urinary 24-hour creatinine clearance

    Time frame: up to day 11

07

Study locations

1 site
  • 1333.43.1 Boehringer Ingelheim Investigational Site
    Berlin, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02202512
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Jul 29, 2014
Start date
Sep 2014
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Dec 24, 2014

Study contacts

Boehringer Ingelheim
study chair · Boehringer Ingelheim
View the source record on ClinicalTrials.gov ↗

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