NCT00820885

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pharmacokinetics and Safety of Elevated Doses

Interventions

Type	Name	Description
DRUG	teduglutide	subcutaneous injection given once a day in the abdomen. Drug is lypholized powder.
DRUG	teduglutide	Once daily subcutaneous injection in the abdomen. Drug is lypholized powder reconstituted with sterile water
DRUG	tedguglutide	lypholized powder reconstituted with sterile water and injection subcutaneously once a day in the abdomen.

Timeline

• Start date: 2006-09-06
• Primary completion: 2007-04-23
• Completion: 2007-04-23
• First posted: 2009-01-12
• Last updated: 2021-05-25

Locations

1 site across 1 country: United States