NCT01028768

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

May 7, 2012

Status Verified

April 1, 2010

Enrollment Period

3 months

First QC Date

December 3, 2009

Last Update Submit

May 4, 2012

Conditions

Renal Impairment

Keywords

Renal impairmentRenal impairment study

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics of teduglutide

    24 hrs

Secondary Outcomes (1)

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

    7 days

Study Arms (1)

Teduglutide

EXPERIMENTAL
Drug: Teduglutide

Interventions

TeduglutideDRUG

10 mg, one-time subcutaneous

Teduglutide

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nycomed GmbH

Konstanz, 78467, Germany

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

teduglutide

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 3, 2009

First Posted

December 9, 2009

Study Start

October 1, 2009

Primary Completion

January 1, 2010

Study Completion

March 1, 2010

Last Updated

May 7, 2012

Record last verified: 2010-04

Locations

DE(1)