DRUG
teduglutide
subcutaneous injection given once a day in the abdomen. Drug is lypholized powder.
Status
Completed
Phase
Phase 1
Enrollment
95
Locations
1
Results
Not posted
Publications
0
Study 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.
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
DRUG
subcutaneous injection given once a day in the abdomen. Drug is lypholized powder.
DRUG
Once daily subcutaneous injection in the abdomen. Drug is lypholized powder reconstituted with sterile water
DRUG
lypholized powder reconstituted with sterile water and injection subcutaneously once a day in the abdomen.
Timeline
First posted
Jan 12, 2009
Study start
Sep 6, 2006
Primary completion
Apr 23, 2007
Study completion
Apr 23, 2007
Results posted
Not reported
Registry updated
May 25, 2021
Outcomes
Each dose arm is safe
Time frame · Within 1 week of each cohort completion
Not reported in the indexed record.
Eligibility
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
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Northwest Kinetics
Tacoma, Washington, United States
Publications
No PMID-linked publications were present in this registry snapshot.
Related trials
Takeda · Short Bowel Syndrome
Phase 3
Recruiting
13
2026-06
International Centre for Diarrhoeal Disease Research, Bangladesh · Environmental Enteric Dysfunction
Phase 2
Not yet recruiting
55
2026-04
Takeda · Short Bowel Syndrome
Not applicable
Active, not recruiting
250
2026-04
Takeda · Short Bowel Syndrome (SBS)
Not applicable
Recruiting
12
2026-03
Meyer Children's Hospital IRCCS · Short Bowel Syndrome (SBS)
Not applicable
Recruiting
50
2026-02
Takeda · Short Bowel Syndrome (SBS)
Not applicable
Recruiting
600
2026-01
Shire · Short Bowel Syndrome
Not applicable
Active, not recruiting
1,806
2025-10
Assistance Publique - Hôpitaux de Paris · Short Bowel Syndrome
Phase 4
Completed
25
2025-09
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.