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

NCT ID: NCT01028768

Last Updated: 2012-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-03-31

Brief Summary

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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

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Pharmacokinetic study.

Conditions

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Renal Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Teduglutide

Group Type EXPERIMENTAL

Teduglutide

Intervention Type DRUG

10 mg, one-time subcutaneous

Interventions

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Teduglutide

10 mg, one-time subcutaneous

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with moderate, severe and end stage renal failure and matched healthy controls.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NPS Pharma

INDUSTRY

Sponsor Role collaborator

Nycomed

INDUSTRY

Sponsor Role lead

Responsible Party

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Nycomed GmbH

Locations

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Nycomed GmbH

Konstanz, , Germany

Site Status

Countries

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Germany

Other Identifiers

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TE-1777-101-EC

Identifier Type: -

Identifier Source: org_study_id

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