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

May 24, 2021 updated by: Shire
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Healthy subjects are enrolled once they have been screened and it is determined they qualify. The subjects are randomized to either placebo or the dose of teduglutide as outlined by the protocol at a 1:3 ratio. They will be injected with investigational product for eight consecutive days, with measurements taken including safety.

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Tacoma, Washington, United States, 98418
        • Northwest Kinetics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women between 20 and 55 years of age
  • BMI of 18-35 inclusive
  • Able to understand and sign informed consent form
  • Willing and able to be confined at the clinical research center 8.5 days
  • Women who are post-menopausal, surgically sterilized, or agree to use effective form of birth control
  • Women of child bearing potential with a negative pregnancy test at screening and check-in
  • Medically healthy with normal clinical results and ECG/lab profiles at screening and check-in

Exclusion Criteria

  • Donated 1 pint or more of blood/blood products within 56 days prior to study or received plasma within 7 days prior to study
  • Pregnancy or become pregnant
  • Participated in another investigational trial 30 days prior
  • Physical examination/medical history indicates clinical condition or concurrent illness unsuitable for study
  • History/presence of clincally significant disease of any body system
  • History/evidence of congenital hon-hemolytic hyperbilirubinemia
  • History/evidence of gall stone disease, stomach or intestinal surgery
  • History/evidence of colorectal cancer
  • History/evidence of GI disease, e.g., malabsorption, Crohn's Disease, etc.
  • History/evidence of skin rashes or dermatitis
  • Taking prescription or over the counter medication (with the exception of oral contraception) during the 7 days preceding confinement to the clinical unit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: cohort A
20 mg dose 20 mg/ML concentration and placebo
Drug: teduglutide
subcutaneous injection given once a day in the abdomen. Drug is lypholized powder.
Other Names:
  • Gattex is the brand name
Drug: teduglutide
Once daily subcutaneous injection in the abdomen. Drug is lypholized powder reconstituted with sterile water
Other Names:
  • Gattex
Drug: tedguglutide
lypholized powder reconstituted with sterile water and injection subcutaneously once a day in the abdomen.
Other Names:
  • Gattex
Other: Cohort AR
20 mg in 50 mg/ml concentration and placebo
Drug: teduglutide
subcutaneous injection given once a day in the abdomen. Drug is lypholized powder.
Other Names:
  • Gattex is the brand name
Drug: teduglutide
Once daily subcutaneous injection in the abdomen. Drug is lypholized powder reconstituted with sterile water
Other Names:
  • Gattex
Drug: tedguglutide
lypholized powder reconstituted with sterile water and injection subcutaneously once a day in the abdomen.
Other Names:
  • Gattex
Other: Cohort C
25 mg in 50mg/ml concentration and placebo
Drug: teduglutide
subcutaneous injection given once a day in the abdomen. Drug is lypholized powder.
Other Names:
  • Gattex is the brand name
Drug: teduglutide
Once daily subcutaneous injection in the abdomen. Drug is lypholized powder reconstituted with sterile water
Other Names:
  • Gattex
Drug: tedguglutide
lypholized powder reconstituted with sterile water and injection subcutaneously once a day in the abdomen.
Other Names:
  • Gattex
Other: Cohort D
15 mg in 50mg/ml concentration and placebo
Drug: teduglutide
subcutaneous injection given once a day in the abdomen. Drug is lypholized powder.
Other Names:
  • Gattex is the brand name
Drug: teduglutide
Once daily subcutaneous injection in the abdomen. Drug is lypholized powder reconstituted with sterile water
Other Names:
  • Gattex
Drug: tedguglutide
lypholized powder reconstituted with sterile water and injection subcutaneously once a day in the abdomen.
Other Names:
  • Gattex
Other: Cohort E
10 mg in 50mg/ml concentration and placebo
Drug: teduglutide
subcutaneous injection given once a day in the abdomen. Drug is lypholized powder.
Other Names:
  • Gattex is the brand name
Drug: teduglutide
Once daily subcutaneous injection in the abdomen. Drug is lypholized powder reconstituted with sterile water
Other Names:
  • Gattex
Drug: tedguglutide
lypholized powder reconstituted with sterile water and injection subcutaneously once a day in the abdomen.
Other Names:
  • Gattex
Other: Cohort F
30mg in 50mg/ml concentration and placebo
Drug: teduglutide
subcutaneous injection given once a day in the abdomen. Drug is lypholized powder.
Other Names:
  • Gattex is the brand name
Drug: teduglutide
Once daily subcutaneous injection in the abdomen. Drug is lypholized powder reconstituted with sterile water
Other Names:
  • Gattex
Drug: tedguglutide
lypholized powder reconstituted with sterile water and injection subcutaneously once a day in the abdomen.
Other Names:
  • Gattex
Other: Cohort H
50mg in 50mg/ml concentration and placebo
Drug: teduglutide
subcutaneous injection given once a day in the abdomen. Drug is lypholized powder.
Other Names:
  • Gattex is the brand name
Drug: teduglutide
Once daily subcutaneous injection in the abdomen. Drug is lypholized powder reconstituted with sterile water
Other Names:
  • Gattex
Drug: tedguglutide
lypholized powder reconstituted with sterile water and injection subcutaneously once a day in the abdomen.
Other Names:
  • Gattex
Other: cohort I
80mg in 50mg/ml concentration and placebo
Drug: teduglutide
subcutaneous injection given once a day in the abdomen. Drug is lypholized powder.
Other Names:
  • Gattex is the brand name
Drug: teduglutide
Once daily subcutaneous injection in the abdomen. Drug is lypholized powder reconstituted with sterile water
Other Names:
  • Gattex
Drug: tedguglutide
lypholized powder reconstituted with sterile water and injection subcutaneously once a day in the abdomen.
Other Names:
  • Gattex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Each dose arm is safe
Time Frame: Within 1 week of each cohort completion
Within 1 week of each cohort completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shire

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2006

Primary Completion (Actual)

April 23, 2007

Study Completion (Actual)

April 23, 2007

Study Registration Dates

First Submitted

January 8, 2009

First Submitted That Met QC Criteria

January 9, 2009

First Posted (Estimate)

January 12, 2009

Study Record Updates

Last Update Posted (Actual)

May 25, 2021

Last Update Submitted That Met QC Criteria

May 24, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL0600-022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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