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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pharmacokinetics and Safety of Elevated Doses

Intervention / Treatment
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* Drug: teduglutide
* Drug: teduglutide
* Drug: tedguglutide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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