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

Phase 1

Completed

• Conditions: Renal Impairment
• Interventions: Drug: Teduglutide

• Registration Number: NCT01028768
• Lead Sponsor: Nycomed

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 Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-12-03
• Study First Submitted QC: 2009-12-07
• Study First Posted: 2009-12-09
• Primary Completion: 2010-01
• Study Completion: 2010-03
• Status Verified: 2010-04
• Last Update Submitted: 2012-05-04
• Last Update Posted: 2012-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Teduglutide	Teduglutide	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of teduglutide	24 hrs

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nycomed GmbH; 🇩🇪 Konstanz, Germany