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

Nycomed36 enrolled

Overview

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.

Pharmacokinetic study.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

Renal Impairment

Interventions

TeduglutideDRUG

10 mg, one-time subcutaneous

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects with moderate, severe and end stage renal failure and matched healthy controls.

Locations (1)

Nycomed GmbH

Konstanz, Germany

Outcomes

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

Data from ClinicalTrials.gov

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