NCT04465396

A Study to Evaluate the Bioavailability of Teduglutide Administered Subcutaneously by Syringe Injection Versus Pen Injector in Healthy Adult Participants

A Randomized, Open-label, Two-treatment, Two-period, Single-dose, Crossover Study to Evaluate the Bioavailability of Teduglutide Administered Subcutaneously by Syringe Injection Versus Pen Injector in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the bioavailability of teduglutide administered as a single subcutaneous (SC) fixed dose (depending upon participant weightband assignment) delivered by a syringe injection and the same fixed dose delivered by the pen injector in healthy participants.

Detailed description

This is a 2-period crossover study and consists of two cohorts. Cohort 1 consists of participant's with greater than or equal to (\>=) 40.0 kilogram (kg) to lesser than or equal to (\<=) 75.0 kg of weight and Cohort 2 consists of participant's with greater than (\>) 75.0 kg to \<= 120.0 kg of weight. Participants in each cohort will be randomized to 1 of 2 treatment sequences AB or BA. Randomization will be stratified by injection site (i.e., thigh, abdomen, and arm) within each cohort.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Teduglutide	Participants received 3 mg or 4 mg of Teduglutide SC syringe injection followed by pen injector or vice versa depending upon the treatment sequence AB or BA on Day 1 of Treatment Periods 1 and 2.
DEVICE	Syringe Injection	Teduglutide was administered using syringe.
DEVICE	Pen injector	Teduglutide was administered using pen injector.

Timeline

• Start date: 2021-01-13
• Primary completion: 2021-08-20
• Completion: 2021-08-20
• First posted: 2020-07-10
• Last updated: 2022-10-04
• Results posted: 2022-10-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study