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

NCT03408132 | Completed Phase 1 DMC

• 1 other identifier: GLY-321-2017
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

SBS - Short Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events

  Adverse events as assessed by CTCAE v4.03

  Day -28 to Day 26 plus 6 weeks

Secondary Outcomes (13)

• Assessment of intestinal insufficiency and gut absorption

  Day -28 to day 26

• Assessment of intestinal insufficiency and gut absorption

  Day -28 and day 26

• Assessment of intestinal insufficiency and gut absorption

  Day -28 and day 26

• Assessment of intestinal insufficiency and gut absorption

  Day -28 and day 26

• Assessment of intestinal insufficiency and gut absorption

  Day -28 to day 26 plus 6 weeks

Study Arms (1)

FE203799 5 mg

EXPERIMENTAL

FE203799 5 mg subcutaneous injection

Drug: FE203799

Interventions

FE203799 DRUG

FE203799 5 mg subcutaneous once weekly

Also known as: GLP 2 analogue

FE203799 5 mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females with SBS secondary to surgical resection of the small intestine, with or without an intact colon.
• 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)

You may not qualify if:

• Pregnancy or lactation
• Positive results on the human immunodeficiency virus (HIV), hepatitis B and/or C tests
• A history of clinically significant intestinal adhesions and/or chronic abdominal pain
• Require chronic systemic narcotics for treatment of pain that exceeds an amount corresponding to 80 mg of morphine per day
• History of cancer or clinically significant lymphoproliferative disease within ≤5 years, except for adequately treated basal cell skin cancer
• History of gallstone within the past 3 years. Gallstone with subsequent cholecystectomy to resolve the issues is acceptable.
• Inflammatory bowel disease patients (IBD) who have NOT been on a stable drug treatment regimen for at least the past 4 weeks
• Evidence of active IBD in the past 12 weeks
• Visible blood in the stool within the last 3 months
• Decompensated heart failure (New York Heart Association \[NYHA\] class III-IV, see Appendix 12.2) and/or known coronary heart disease defined as unstable angina pectoris and/or myocardial infarction within the last 6 months prior to screening
• Radiation enteritis, scleroderma or other condition of intestinal dysmotility, coeliac disease, refractory or tropical sprue
• History of alcohol and/or drug abuse within the last 12 months
• Inadequate hepatic function as defined by: bilirubin \>upper limit of normal (ULN), alanine transaminase (ALT) or aspartate transaminase (AST) \>2.0 × ULN; alkaline phosphatase (ALP) \>2.5 × ULN; or international normalised ratio (INR) \>1.5 × ULN
• Inadequate renal function as defined by serum creatinine or blood urea nitrogen \>2.5 x ULN
• Unplanned hospitalisation of \>24 hours duration within 1 month before the screening visit

Sponsors & Collaborators

• GlyPharma Therapeutics: lead
• VectivBio AG: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Short Bowel Syndrome

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tomasz Masior

  VectivBio AG

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: January 23, 2018
• Study Start: May 2, 2018
• Primary Completion: October 28, 2019
• Study Completion: October 28, 2019
• Last Updated: October 24, 2024

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)