Philadelphia, Pennsylvania


Purpose:

The purpose of this study is to evaluate the safety and clinical pharmacology of a single dose pharmacokinetics and pharmacodynamics of XOMA 358 in subjects with hypoglycemia associated with congenital hyperinsulinism.


Criteria:

Inclusion Criteria: - Clinical diagnosis of congenital hyperinsulinism - Duration of glucose levels less than 70mg/dL, by CGM, for an average of at least 120 minutes a day across baseline Days -3, -2, and -1 with no single duration less than 60 minutes on any of the baseline Days -3, -2, or -1, unless the subject received rescue treatment. - Can safely washout of background medications used to treat hyperinsulinism. Exclusion Criteria: - Use of any agent, such as diazoxide, octreotide, chronic systemic glucocorticoids, or β agonists that may affect glucose metabolism - Body Mass Index ≥ 35 kg/m2 - Pregnant females, females planning to become pregnant during the course of the study, females who have delivered 3 months before screening, or breastfeeding - Male subjects who are planning a pregnancy with a female partner during the course of the study or within 4 months after administration of study drug.


NCT ID:

NCT02604485


Primary Contact:

Study Director
Allan Gordon, MD, PhD
XOMA (US) LLC

Ann Neale
Phone: 510-204-7515


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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