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

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02202512
• Collaborator: (none)
• Enrollment: 53
• Location: 1
• Arms: 5
• Duration (Months): 3
• Patients Per Site Per Month: 17.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Placebo; Drug: Cimetidine; Drug: Placebo; Drug: Placebo; Drug: BI 1060469 high dose; Drug: BI 1060469 low dose; Drug: Naproxen; Drug: BI 1021958	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 53 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Primary Purpose: Treatment
• Official Title: 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)
• Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BI 1060469 low dose Low-Dose,Tablet,oral administration with 240 ml water,over 10 days	Drug: Placebo; tablets; Drug: BI 1060469 low dose; tablets
Experimental: BI 1060469 high dose High-Dose,Tablets,oral administration with 240 ml water, over 10 days	Drug: Placebo; tablets; Drug: BI 1060469 high dose; tablets
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; tablets; Drug: BI 1021958; tablets

Outcome Measures

Primary Outcome Measures

1. measured glomerular filtration rate (mGFR) based on renal iohexol clearance [up to day 11]

Secondary Outcome Measures

1. measured urinary 24-hour creatinine clearance [up to day 11]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: 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:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	1333.43.1 Boehringer Ingelheim Investigational Site	Berlin		Germany

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT02202512
• Other Study ID Numbers: 1333.43; 2014-000320-20
• First Posted: Jul 29, 2014
• Last Update Posted: Dec 24, 2014
• Last Verified: Dec 1, 2014

• Additional relevant MeSH terms: Naproxen; Cimetidine

Study Results

No Results Posted as of Dec 24, 2014