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Completed

NCT Number: NCT00833716

Effect of Renal Impairment on the Pharmacokinetics of NN9535

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Renal Impairment Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

semaglutide

Drug

10 mg/mL of semaglutide solution for s.c. injection, single dose

Other names: NN9535

Primary outcomes

  1. AUC of NN9535

    Time frame: at 21 days

Secondary outcomes

  1. Laboratory safety, adverse events

    Time frame: at 21 days

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

An Open-label Trial Investigating the Pharmacokinetics and the Tolerability of NN9535 in Subjects With Normal Renal Function and Various Degrees of Impaired Renal Function

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 2, 2009
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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