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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: Cimetidine; Drug: Naproxen; Drug: BI 1060469 high dose; Drug: BI 1060469 low dose; Drug: BI 1021958

• Registration Number: NCT02202512
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-28
• Study First Submitted QC: 2014-07-28
• Study First Posted: 2014-07-29
• Study Start: 2014-09
• Status Verified: 2014-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-23
• Last Update Posted: 2014-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 53

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 1021958	Placebo	High-Dose,Tablets,oral administration with 240 ml water, over 10 days
BI 1060469 high dose	Placebo	High-Dose,Tablets,oral administration with 240 ml water, over 10 days
BI 1060469 high dose	BI 1060469 high dose	High-Dose,Tablets,oral administration with 240 ml water, over 10 days
BI 1060469 low dose	Placebo	Low-Dose,Tablet,oral administration with 240 ml water,over 10 days
BI 1060469 low dose	BI 1060469 low dose	Low-Dose,Tablet,oral administration with 240 ml water,over 10 days
BI 1021958	BI 1021958	High-Dose,Tablets,oral administration with 240 ml water, over 10 days
Cimetidine	Cimetidine	-
Naproxen	Naproxen	-

Primary Outcome Measures

Name	Time	Method
measured glomerular filtration rate (mGFR) based on renal iohexol clearance	up to day 11

Secondary Outcome Measures

Name	Time	Method
measured urinary 24-hour creatinine clearance	up to day 11

Trial Locations

Locations (1)

1333.43.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Berlin, Germany