Pharmacokinetics and Safety of Elevated Doses
Conditions
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 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
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.
Interventions
DRUGteduglutide
subcutaneous injection given once a day in the abdomen. Drug is lypholized powder.
DRUGtedguglutide
lypholized powder reconstituted with sterile water and injection subcutaneously once a day in the abdomen.
Sponsors
Shire
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Each dose arm is safe | Within 1 week of each cohort completion |
Countries
United States
Outcome results
None listed