Metabolic Balance Study of FE203799 in Patients With SBS With Intestinal Insufficiency (NCT03408132) | Clinical Trial Compass
CompletedPhase 1/2
Metabolic Balance Study of FE203799 in Patients With SBS With Intestinal Insufficiency
Denmark8 participantsStarted 2018-05-02
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Males and females with SBS secondary to surgical resection of the small intestine, with or without an intact colon.
✓. 18-80 years of age
✓. Average faecal wet weight excretion of ≥1500 g/day during the baseline balance study
✓. Average urine production \<2000 mL/day during the baseline balance study
✓. Body Mass Index (BMI) between 16.0 and 32.0 (both inclusive)
✓. At least 6 months since last surgical bowel resection
✓. Willing to adhere to a defined oral intake of fluids on certain days as required by the protocol (and based on the individual's routine daily consumption)
✓. Women of childbearing potential must agree to use an adequate method of contraception during the trial and for 60 days after the end-of-trial visit. Adequate methods of contraception include intrauterine device or hormonal contraception (oral contraceptive pill, depot injections or implant, transdermal depot patch or vaginal ring). To be considered sterilised or infertile, females must have undergone surgical sterilisation (bilateral tubectomy, hysterectomy or bilateral ovariectomy) or be post-menopausal (defined as at least 12 months amenorrhoea and confirmed with follicle-stimulating hormone \[FSH\] test)
Exclusion criteria
✕. Pregnancy or lactation
✕. Positive results on the human immunodeficiency virus (HIV), hepatitis B and/or C tests