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

• Sponsor: Nycomed (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01028768
• Collaborator: NPS Pharma (Industry)
• Enrollment: 36
• Location: 1
• Arm: 1
• Duration (Months): 5
• Patients Per Site Per Month: 7.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Impairment	Drug: Teduglutide	Phase 1

Detailed Description

Pharmacokinetic study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Jan 1, 2010
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Teduglutide	Drug: Teduglutide; 10 mg, one-time subcutaneous

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics of teduglutide [24 hrs]

Secondary Outcome Measures

1. Safety and tolerability of 10 mg teduglutide (assessed by physical examination, vital signs, clinical laboratory, electrocardiogram [ECG] and adverse events [AE]) [7 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects with moderate, severe and end stage renal failure and matched healthy controls.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nycomed GmbH	Konstanz		Germany	78467

Sponsors and Collaborators

• Nycomed
• NPS Pharma

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01028768
• Other Study ID Numbers: TE-1777-101-EC
• First Posted: Dec 9, 2009
• Last Update Posted: May 7, 2012
• Last Verified: Apr 1, 2010

• Keywords provided by , ,: Renal impairment; Renal impairment study
• Additional relevant MeSH terms: Renal Insufficiency; Teduglutide

Study Results

No Results Posted as of May 7, 2012