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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Cimetidine; Drug: Placebo; Drug: Naproxen; Drug: BI 1060469 high dose; Drug: BI 1021958; Drug: BI 1060469 low dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT02202512

1333.43

2014-000320-20 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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53 participants in 5 patient groups

BI 1060469 low dose

Experimental group

Description:

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

Treatment:

Drug: BI 1060469 low dose

Drug: Placebo

Drug: Placebo

Drug: Placebo

BI 1060469 high dose

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Placebo

Drug: BI 1060469 high dose

Drug: Placebo

Cimetidine

Active Comparator group

Treatment:

Drug: Cimetidine

Naproxen

Active Comparator group

Treatment:

Drug: Naproxen

BI 1021958

Experimental group

Description:

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

Treatment:

Drug: BI 1021958

Drug: Placebo

Drug: Placebo

Drug: Placebo