A Double-Blind Multi-Dose Tolerability and Pharmacokinetic Study of Teduglutide
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ClinicalTrials.gov Identifier: NCT00820885 |
Recruitment Status :
Completed
First Posted : January 12, 2009
Last Update Posted : November 13, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pharmacokinetics and Safety of Elevated Doses | Drug: teduglutide Drug: tedguglutide | Phase 1 |
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 |

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 |
- Each dose arm is safe [ Time Frame: Within 1 week of each cohort completion ]

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

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
United States, Washington | |
Northwest Kinetics | |
Tacoma, Washington, United States, 98418 |
Principal Investigator: | Paula Shaw, M.D. | Investigator with Northwest Kinetics |
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 |
Teduglutide Gastrointestinal Agents Radiation-Protective Agents Protective Agents Physiological Effects of Drugs |