A Double-Blind Multi-Dose Tolerability and Pharmacokinetic Study of Teduglutide
Completed · Phase 1
Conditions studied: Pharmacokinetics and Safety of Elevated Doses
In brief
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.
Key facts
- Study ID
- NCT00820885
- Run by
- Shire
- People needed
- 95
- Starts
- 2006-09-06
- Expected to finish
- 2007-04-23
- Last updated by the study team
- 2021-05-25
Who can join
Age: 20 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Northwest Kinetics — Tacoma, Washington, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.