Safety, Efficacy, PD of FE203799 in Short Bowel Syndrome on Parenteral Support
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Part A:once weekly dosing for 4 weeks in patients with short bowel syndrome who require total
      parenteral nutrition; patients will complete period 1 and after a 6-10 week wash-out, they
      will enter period 2 (active treatment and placebo); Part B: treatment period 3, is an open
      label extension to part A and starts after a washout of 6-10 weeks after the last dose in
      treatment period 2. patients are dosed once weekly for 4 weeks.
    

Detailed description: 
      This trial is divided into 2 parts. Part A of this trial is a repeated dose, placebo
      controlled, double blind, randomised cross-over trial investigating safety, efficacy and PD
      of FE 203799 in 8-10 patients with SBS. Additionally, the plasma concentration of FE 203799
      will be assessed for determination of the trough and post-dose concentration in SBS patients.
      The patients will receive a subcutaneous (SC) dose of 5 mg FE 203799 or placebo once weekly
      for 4 consecutive weeks, and after a washout period of 6-10 weeks, the alternate treatment
      will be administered once weekly for 4 consecutive weeks. Safety follow-up assessments will
      be performed 6-10 weeks after the last dose in each treatment period.

      Part B of this trial, treatment period 3, is an open label extension to part A that will test
      a new dose. Following a washout period of 6-10 weeks after the last dose in treatment period
      2, the new dose will be administered once weekly for 4 weeks. Safety follow-up assessments
      will be performed 4-6 weeks after the last dose in treatment period 3.

      The first two administrations of trial drug in each treatment period will be performed at the
      clinic, while the third and fourth 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.

      Prior to each administration of trial drug, liver function parameters will be analysed and
      assessed. During each treatment period, 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 during each treatment period with daily data on parenteral
      support (PS) usage, oral liquid intake at specific periods, trial drug administrations
      performed at home, local tolerability and adverse events (AEs).
    

Intervention name(s): FE203799 GLP-2 analogue; FE203799 Placebo GLP-2 analogue; FE203799 GLP-2 analogue
Intervention type(s): Drug; Drug; Drug
Intervention description(s): FE203799 5 mg subQ once weekly; Placebo subQ once weekly; FE203799 10 mg subQ once weekly
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care