A Double-Blind Multi-Dose Tolerability and Pharmacokinetic Study of Teduglutide
- Conditions
- Pharmacokinetics and Safety of Elevated Doses
- Interventions
- Drug: tedguglutide
- Registration Number
- NCT00820885
- Lead Sponsor
- Shire
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 95
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort D tedguglutide 15 mg in 50mg/ml concentration and placebo Cohort C tedguglutide 25 mg in 50mg/ml concentration and placebo cohort A tedguglutide 20 mg dose 20 mg/ML concentration and placebo Cohort AR tedguglutide 20 mg in 50 mg/ml concentration and placebo Cohort F tedguglutide 30mg in 50mg/ml concentration and placebo Cohort H tedguglutide 50mg in 50mg/ml concentration and placebo Cohort E tedguglutide 10 mg in 50mg/ml concentration and placebo cohort I tedguglutide 80mg in 50mg/ml concentration and placebo cohort A teduglutide 20 mg dose 20 mg/ML concentration and placebo Cohort AR teduglutide 20 mg in 50 mg/ml concentration and placebo Cohort C teduglutide 25 mg in 50mg/ml concentration and placebo Cohort D teduglutide 15 mg in 50mg/ml concentration and placebo Cohort E teduglutide 10 mg in 50mg/ml concentration and placebo Cohort F teduglutide 30mg in 50mg/ml concentration and placebo Cohort H teduglutide 50mg in 50mg/ml concentration and placebo cohort I teduglutide 80mg in 50mg/ml concentration and placebo
- Primary Outcome Measures
Name Time Method Each dose arm is safe Within 1 week of each cohort completion
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Northwest Kinetics
🇺🇸Tacoma, Washington, United States