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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00820885
Recruitment Status : Completed
First Posted : January 12, 2009
Last Update Posted : November 13, 2015
Sponsor:
Information provided by (Responsible Party):
Shire

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Pharmacokinetics and Safety of Elevated Doses Drug: teduglutide Drug: tedguglutide Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: A Double-Blind Multi-Dose Tolerability and Pharmacokinetic Study of Teduglutide
Study Start Date : July 2006
Actual Primary Completion Date : April 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Teduglutide

Arms and Interventions
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Arm Intervention/treatment
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 Name: Gattex is the brand name

Drug: teduglutide
Once daily subcutaneous injection in the abdomen. Drug is lypholized powder reconstituted with sterile water
Other Name: Gattex

Drug: tedguglutide
lypholized powder reconstituted with sterile water and injection subcutaneously once a day in the abdomen.
Other Name: Gattex
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 Name: Gattex is the brand name

Drug: teduglutide
Once daily subcutaneous injection in the abdomen. Drug is lypholized powder reconstituted with sterile water
Other Name: Gattex

Drug: tedguglutide
lypholized powder reconstituted with sterile water and injection subcutaneously once a day in the abdomen.
Other Name: Gattex
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 Name: Gattex is the brand name

Drug: teduglutide
Once daily subcutaneous injection in the abdomen. Drug is lypholized powder reconstituted with sterile water
Other Name: Gattex

Drug: tedguglutide
lypholized powder reconstituted with sterile water and injection subcutaneously once a day in the abdomen.
Other Name: Gattex
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 Name: Gattex is the brand name

Drug: teduglutide
Once daily subcutaneous injection in the abdomen. Drug is lypholized powder reconstituted with sterile water
Other Name: Gattex

Drug: tedguglutide
lypholized powder reconstituted with sterile water and injection subcutaneously once a day in the abdomen.
Other Name: Gattex
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 Name: Gattex is the brand name

Drug: teduglutide
Once daily subcutaneous injection in the abdomen. Drug is lypholized powder reconstituted with sterile water
Other Name: Gattex

Drug: tedguglutide
lypholized powder reconstituted with sterile water and injection subcutaneously once a day in the abdomen.
Other Name: Gattex
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 Name: Gattex is the brand name

Drug: teduglutide
Once daily subcutaneous injection in the abdomen. Drug is lypholized powder reconstituted with sterile water
Other Name: Gattex

Drug: tedguglutide
lypholized powder reconstituted with sterile water and injection subcutaneously once a day in the abdomen.
Other Name: Gattex
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 Name: Gattex is the brand name

Drug: teduglutide
Once daily subcutaneous injection in the abdomen. Drug is lypholized powder reconstituted with sterile water
Other Name: Gattex

Drug: tedguglutide
lypholized powder reconstituted with sterile water and injection subcutaneously once a day in the abdomen.
Other Name: Gattex
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 Name: Gattex is the brand name

Drug: teduglutide
Once daily subcutaneous injection in the abdomen. Drug is lypholized powder reconstituted with sterile water
Other Name: Gattex

Drug: tedguglutide
lypholized powder reconstituted with sterile water and injection subcutaneously once a day in the abdomen.
Other Name: Gattex


Outcome Measures
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Primary Outcome Measures :
  1. Each dose arm is safe [ Time Frame: Within 1 week of each cohort completion ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00820885


Locations
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United States, Washington
Northwest Kinetics
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
Shire
Investigators
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Principal Investigator: Paula Shaw, M.D. Investigator with Northwest Kinetics
More Information
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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00820885    
Other Study ID Numbers: CL0600-022
First Posted: January 12, 2009    Key Record Dates
Last Update Posted: November 13, 2015
Last Verified: January 2009
Additional relevant MeSH terms:
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Teduglutide
Gastrointestinal Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs