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

• Status: Completed
• Trial end date: 2007-04-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shire
• Treatments: Teduglutide

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