Effect of Renal Impairment on the Pharmacokinetics of NN9535

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

Sponsors

Lead Sponsor: Novo Nordisk A/S

Source Novo Nordisk A/S
Brief 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.

Overall Status Completed
Start Date February 2, 2009
Completion Date July 26, 2010
Primary Completion Date July 26, 2010
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
AUC of NN9535 at 21 days
Secondary Outcome
Measure Time Frame
Laboratory safety, adverse events at 21 days
Enrollment 62
Condition
Intervention

Intervention Type: Drug

Intervention Name: semaglutide

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

Arm Group Label: A

Other Name: NN9535

Eligibility

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Global Clinical Registry (GCR, 1452) Study Director Novo Nordisk A/S
Location
Facility:
Novo Nordisk Investigational Site | Miami, Florida, 33014, United States
Novo Nordisk Investigational Site | Orlando, Florida, 32806, United States
Novo Nordisk Investigational Site | Knoxville, Tennessee, 37920, United States
Location Countries

United States

Verification Date

March 2017

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: A

Type: Experimental

Study Design Info

Allocation: Non-Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov