A Single-Dose Open-Label of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery
Status: | Recruiting |
---|---|
Conditions: | Endocrine |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 5/20/2016 |
Start Date: | April 2016 |
End Date: | October 2016 |
Contact: | Ann Neale |
Phone: | 510-204-7515 |
The purpose of this study is to evaluate the safety and clinical pharmacology of a single
dose of XOMA 358 in patients with hypoglycemia after gastric bypass surgery.
dose of XOMA 358 in patients with hypoglycemia after gastric bypass surgery.
Inclusion Criteria:
- Aged at least 18 years of age
- Weight ≥ 60 kg and ≤ 120 kg and Body Mass Index < 35 kg/m2 at baseline
- Received gastric bypass surgery more than 1 year before dosing
- Occurrence of postprandial hypoglycemia during the baseline period assessments
Exclusion Criteria:
- History of type 1 diabetes
- Planned use of the following medications on or after Day -3:
- Any agent for hypoglycemia, such as diazoxide or octreotide
- Antihyperglycemic agents, including subcutaneous insulin therapy, sulfonylureas,
SGLT2 inhibitors, and GLP-1 agonists
- Systemic glucocorticoids or β agonists that may affect glucose metabolism
- Long-acting somatostatin analogs or glucose-affecting medications
- Major general surgery within 3 months before study entry or anticipated during the
study period
Other protocol-defined inclusion/exclusion criteria may apply
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