Pharmacokinetics of 10 mg Teduglutide in Subjects With Renal Impairment Compared to Healthy Subjects With Normal Renal Function
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.
|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|
- Pharmacokinetics of teduglutide [ Time Frame: 24 hrs ] [ Designated as safety issue: Yes ]
- 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 ]
|Study Start Date:||October 2009|
|Study Completion Date:||March 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
10 mg, one-time subcutaneous
Please refer to this study by its ClinicalTrials.gov identifier: NCT01028768
|Konstanz, Germany, 78467|