DRUG
Teduglutide
10 mg, one-time subcutaneous
Pharmacokinetics of 10 mg Teduglutide in Subjects With Renal Impairment Compared to Healthy Subjects With Normal Renal Function
Status
Completed
Phase
Phase 1
Enrollment
36
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full detailed description
Pharmacokinetic study.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Dec 9, 2009
Study start
Oct 2009
Primary completion
Jan 2010
Study completion
Mar 2010
Results posted
Not reported
Registry updated
May 7, 2012
Outcomes
What the study measures.
Primary outcomes
Pharmacokinetics of teduglutide
Time frame · 24 hrs
Secondary outcomes
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
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Subjects with moderate, severe and end stage renal failure and matched healthy controls.
Study locations
1 registered sites.
Germany. Showing up to 24 locations stored in the fast local snapshot.
Nycomed GmbH
Konstanz, Germany
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
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