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

Renal Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01028768
• Other study ID #: TE-1777-101-EC
• Status: Completed
• Phase: Phase 1
• First received: December 3, 2009
• Last updated: May 4, 2012
• Start date: October 2009
• Est. completion date: March 2010

Study information

• Verified date: April 2010
• Source: Nycomed
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Description:

Pharmacokinetic study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• Teduglutide
10 mg, one-time subcutaneous

Locations

Country	Name	City	State
Germany	Nycomed GmbH	Konstanz

Sponsors (2)

Lead Sponsor	Collaborator
Nycomed	NPS Pharma

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of teduglutide		24 hrs	Yes
Secondary	Safety and tolerability of 10 mg teduglutide (assessed by physical examination, vital signs, clinical laboratory, electrocardiogram [ECG] and adverse events [AE])		7 days	Yes