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A Double-Blind Multi-Dose Tolerability and Pharmacokinetic Study of Teduglutide

NCT00820885 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2021-05-25

No results posted yet for this study

Summary

The primary objective of the study was to study the safety and tolerability of teduglutide following a once or possibly twice daily subcutaneous injection for eight consecutive days in healthy subjects. A secondary objective was to study the pharmacokinetics of teduglutide following a once or possibly twice daily injection for eight consecutive days in healthy subjects.

Conditions

  • Pharmacokinetics and Safety of Elevated Doses

Interventions

DRUG

teduglutide

subcutaneous injection given once a day in the abdomen. Drug is lypholized powder.

DRUG

teduglutide

Once daily subcutaneous injection in the abdomen. Drug is lypholized powder reconstituted with sterile water

DRUG

tedguglutide

lypholized powder reconstituted with sterile water and injection subcutaneously once a day in the abdomen.

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-09-06
Primary Completion
2007-04-23
Completion
2007-04-23

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00820885 on ClinicalTrials.gov