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A Trial Investigating the Pharmacokinetic (Mode of Action in the Body) and Safety Profiles of NN1250 in Subjects With Various Degrees of Impaired Liver Function and in Subjects With Normal Liver Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00976326
First received: September 11, 2009
Last updated: June 29, 2012
Last verified: June 2012
History of Changes
  Purpose

This trial is conducted in Europe. The aim of this clinical trial is to evaluate if the pharmacokinetic and safety profiles of NN1250 are altered to such an extent that the dose should be adjusted in subjects with impaired liver function compared to the dose for subjects with normal liver function.


Condition Intervention Phase
Diabetes
Healthy
 Drug: NN1250
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Trial Investigating the Pharmacokinetic and Safety Profiles of NN1250 in Subjects With Mild, Moderate and Severe Degrees of Hepatic Impairment and in Subjects With Normal Hepatic Function

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Area under the NN1250 concentration-time curve after single-dose [ Time Frame: from 0 to 120 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum observed NN1250 concentration after single-dose [ Time Frame: from 0 to 120 hours ] [ Designated as safety issue: No ]
  • Renal clearance of NN1250 [ Time Frame: from 0 to 24 hours ] [ Designated as safety issue: No ]
  • Number of adverse events [ Time Frame: from Visit 2, Day -1 until Follow-up Visit ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: August 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A: Healthy volunteers Drug: NN1250
The dose level will be one single dose of 0.4 units per kg body weight injected s.c. (subcutaneously, under the skin)
Experimental: B: Subjects with mild liver impairment Drug: NN1250
The dose level will be one single dose of 0.4 units per kg body weight injected s.c. (subcutaneously, under the skin)
Experimental: C: Subjects with moderate liver impairment Drug: NN1250
The dose level will be one single dose of 0.4 units per kg body weight injected s.c. (subcutaneously, under the skin)
Experimental: D: Subjects with severe liver impairment Drug: NN1250
The dose level will be one single dose of 0.4 units per kg body weight injected s.c. (subcutaneously, under the skin)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects with normal liver function or subjects with stable liver impairment as assessed by the physician
  • Body mass index below or equal to 40.0 kg/m2

Exclusion Criteria:

  • Subject with any disease or condition which the physician feels would interfere with the trial outcome or execution except for conditions associated with liver impairment in the group of subjects with compromised liver function
  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to trial start
  • Not able or willing to refrain from smoking during the clinic stay
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00976326

Locations
Slovakia
Bratislava, Slovakia, 833 05
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Marianne Thrane, MSc., PhD Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT00976326     History of Changes
Other Study ID Numbers: NN1250-1989, 2009-009465-34
Study First Received: September 11, 2009
Last Updated: June 29, 2012
Health Authority: Slovakia: State Institute for Drug Control

ClinicalTrials.gov processed this record on May 22, 2013