Effect of Renal Impairment on the Pharmacokinetics of NN9535

• Status: Completed
• Trial end date: 2010-07-26
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in the United States of America (USA). The aim of this clinical trial is to investigate how different degrees of renal impairment (mild, moderate, severe and end-stage renal disease) affect the pharmacokinetics of NN9535.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S

Criteria

Inclusion Criteria:

• Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)

• Subjects meeting the pre-defined GFR (glomerular filtration rate) criteria (estimated by the Cockcroft & Gault formula) for any of the renal function groups

• Body Mass Index (BMI) equal to or less than 40kg/m2

Exclusion Criteria:

• Known or suspected allergy to trial product(s) or related products

• Renal transplanted patients

• Certain cardiac problems (heart failure, unstable angina, MI (myocardial infarction) within the last 3 months)

• Known current hepatic dysfunction or severe hepatic disease during the last 12 months

• Female of childbearing potential/breast feeding

• History of alcoholism or drug abuse

• Blood donation during the last 8 weeks prior to the study

• Past or current history of pancreatitis