A Single-Dose Open-Label Study of XOMA 358 in Subjects With Congenital Hyperinsulinism

Completed · Phase 2

Conditions studied: Congenital Hyperinsulinism

In brief

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.

Key facts

Study ID

NCT02604485

Run by

XOMA (US) LLC

People needed

10

Starts

2015-10-01

Expected to finish

2017-01-01

Last updated by the study team

2017-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Philadelphia, Pennsylvania, United States
• Study site — London, United Kingdom

Full record on ClinicalTrials.gov

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