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

This study has been completed.

Sponsor:

Collaborator:

NPS Pharmaceuticals

Information provided by:

Nycomed: A Takeda Company

ClinicalTrials.gov Identifier:

NCT01028768

First received: December 3, 2009

Last updated: May 4, 2012

Last verified: April 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	December 3, 2009
Last Updated Date	May 4, 2012
Start Date ^ICMJE	October 2009
Primary Completion Date	January 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 7, 2009)	Pharmacokinetics of teduglutide [ Time Frame: 24 hrs ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01028768 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 7, 2009)	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 ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Pharmacokinetics of 10 mg Teduglutide in Subjects With Renal Impairment Compared to Healthy Subjects With Normal Renal Function
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description	Pharmacokinetic study.
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label
Condition ^ICMJE	Renal Impairment
Intervention ^ICMJE	Drug: Teduglutide 10 mg, one-time subcutaneous
Study Arm (s)	Experimental: Teduglutide Intervention: Drug: Teduglutide
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	36
Completion Date	March 2010
Primary Completion Date	January 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Subjects with moderate, severe and end stage renal failure and matched healthy controls.
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01028768
Other Study ID Numbers ^ICMJE	TE-1777-101-EC
Has Data Monitoring Committee	No
Responsible Party	Head of Exploratory Clinical Development, Nycomed GmbH
Study Sponsor ^ICMJE	Nycomed: A Takeda Company
Collaborators ^ICMJE	NPS Pharmaceuticals
Investigators ^ICMJE	Not Provided
Information Provided By	Nycomed: A Takeda Company
Verification Date	April 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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