NCT03408132

Metabolic Balance Study of FE203799 in Patients With SBS With Intestinal Insufficiency

A Phase Ib/IIa Open-label, Repeated Dose, Metabolic Balance Study of FE 203799 in Patients With Short Bowel Syndrome and Intestinal Insufficiency

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: GlyPharma Therapeutics · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a repeated dose, open label trial investigating safety, efficacy, PD and PK of FE 203799 in 8 patients with SBS. The patients will receive a subcutaneous (SC) dose of 5 mg FE 203799 once weekly for 4 consecutive weeks, and efficacy parameters and PK will be assessed after the fourth dose. Safety follow up assessments will be performed 4-6 weeks after the last dose.

Detailed description

This is a repeated dose, open label trial investigating safety, efficacy, PD and PK of FE 203799 in 8 patients with SBS . The patients will receive a subcutaneous (SC) dose of 5 mg FE 203799 once weekly for 4 consecutive weeks, and efficacy parameters and PK will be assessed after the fourth dose. Safety follow-up assessments will be performed 4-6 weeks after the last dose. The first two administrations of trial drug will be performed at the clinic, while the third dose can be either self-administered by the patient or administered at the clinic if the patient prefers to travel to the site or other considerations make a site visit preferable. The fourth administration of trial drug will be performed at the clinic just prior to assessment of efficacy parameters in the treatment balance study. Prior to each administration of trial drug, liver function parameters will be analysed and assessed. During the entire trial, patients who develop extremely high or persistently elevated liver enzymes following trial drug administration will be discontinued from the trial. The patients will complete a diary with data on trial drug administration performed at home, local tolerability and adverse events (AEs).

Conditions

• SBS - Short Bowel Syndrome

Interventions

Type	Name	Description
DRUG	FE203799	FE203799 5 mg subcutaneous once weekly

Timeline

• Start date: 2018-05-02
• Primary completion: 2019-10-28
• Completion: 2019-10-28
• First posted: 2018-01-23
• Last updated: 2024-10-24

Locations

1 site across 1 country: Denmark