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Pharmacokinetics of 10 mg Teduglutide in Subjects With Renal Impairment Compared to Healthy Subjects With Normal Renal Function

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01028768
First Posted: December 9, 2009
Last Update Posted: May 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
NPS Pharma
Information provided by:
Nycomed
December 3, 2009
December 9, 2009
May 7, 2012
October 2009
January 2010   (Final data collection date for primary outcome measure)
Pharmacokinetics of teduglutide [ Time Frame: 24 hrs ]
Same as current
Complete list of historical versions of study NCT01028768 on ClinicalTrials.gov Archive Site
Safety and tolerability of 10 mg teduglutide (assessed by physical examination, vital signs, clinical laboratory, electrocardiogram [ECG] and adverse events [AE]) [ Time Frame: 7 days ]
Same as current
Not Provided
Not Provided
 
Pharmacokinetics of 10 mg Teduglutide in Subjects With Renal Impairment Compared to Healthy Subjects With Normal Renal Function
Open Label Pharmacokinetic (PK) Study, Conducted at One Investigational Site in Germany, to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of Teduglutide Following Subcutaneous Administration of 10 mg Teduglutide and to Evaluate Safety and Tolerability of 10 mg Teduglutide

To evaluate the effect of renal impairment on the pharmacokinetics (PK) of teduglutide following subcutaneous (SC) administration of 10 mg teduglutide.

Secondary objectives are to assess the safety and tolerability of 10 mg teduglutide. A further objective is the description of the PK of teduglutide following SC administration of 10 mg teduglutide in elderly (≥ 65 years) healthy subjects compared to non elderly healthy subjects.

Pharmacokinetic study.
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Renal Impairment
Drug: Teduglutide
10 mg, one-time subcutaneous
Experimental: Teduglutide
Intervention: Drug: Teduglutide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
March 2010
January 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with moderate, severe and end stage renal failure and matched healthy controls.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01028768
TE-1777-101-EC
No
Not Provided
Not Provided
Head of Exploratory Clinical Development, Nycomed GmbH
Nycomed
NPS Pharma
Not Provided
Nycomed
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP