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
ClinicalTrials.gov Identifier:
NCT01028768
First received: December 3, 2009
Last updated: May 4, 2012
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Renal Impairment
Drug: Teduglutide
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Nycomed:

Primary Outcome Measures:
  • Pharmacokinetics of teduglutide [ Time Frame: 24 hrs ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 36
Study Start Date: October 2009
Study Completion Date: March 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Teduglutide Drug: Teduglutide
10 mg, one-time subcutaneous

Detailed Description:

Pharmacokinetic study.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with moderate, severe and end stage renal failure and matched healthy controls.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01028768

Locations
Germany
Nycomed GmbH
Konstanz, Germany, 78467
Sponsors and Collaborators
Nycomed
NPS Pharmaceuticals
  More Information

No publications provided

Responsible Party: Head of Exploratory Clinical Development, Nycomed GmbH
ClinicalTrials.gov Identifier: NCT01028768     History of Changes
Other Study ID Numbers: TE-1777-101-EC
Study First Received: December 3, 2009
Last Updated: May 4, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Nycomed:
Renal impairment
Renal impairment study

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 28, 2014