Status:
COMPLETED
A Double-Blind Multi-Dose Tolerability and Pharmacokinetic Study of Teduglutide
Lead Sponsor:
Shire
Conditions:
Pharmacokinetics and Safety of Elevated Doses
Eligibility:
All Genders
20-55 years
Phase:
PHASE1
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 subject...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 6 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2007
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT00820885
Start Date
September 6 2006
End Date
April 23 2007
Last Update
May 25 2021
Active Locations (1)
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1
Northwest Kinetics
Tacoma, Washington, United States, 98418