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The purpose of this study is to evaluate the safety and clinical pharmacology of XOMA 358 in patients with hypoglycemia after gastric bypass surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 - single dose | Experimental | Cohorts A, B, and C |
|
| Part 2 - multiple doses | Experimental | Cohort 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XOMA 358 single dose level A | Drug | XOMA 358 single dose level A administered by intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Single dose Part 1 and Multiple dose Part 2 - Incidence of treatment-emergent adverse events - | Safety assessed by treatment-emergent adverse events | 42 days |
| Single dose Part 1 - Change from baseline in glucose levels | Glucose measured using a continuous glucose monitor | Baseline and 22 days |
| Single dose Part 1 - Blood glucose levels | Assessment of blood glucose with a bedside meter at multiple time points specified in the protocol | Daily through Day 11 and at Day 22 |
| Multiple dose Part 2 - Change from baseline of duration of glucose by CGM at various levels as specified in the protocol | Glucose measured by continuous glucose monitoring every 5 min | 28 days |
| Multiple dose Part 2 - Change from baseline of number of episodes and percent of episodes of hypoglycemia per day with glucose by CGM at various levels as defined in the protocol | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
History of type 1 diabetes
Planned use of the following medications on or after Day -3 (Part 1):
During Part 2, the following therapies are prohibited as specified below:
Medications such as tramadol may cause hypoglycemia or fluctuations in blood glucose levels and, as such, use of such medications is subject to the restrictions as described above during the study. Acetaminophen can interfere with the accuracy of the glucose sensor of the continuous glucose monitoring system and is, therefore, prohibited during continuous glucose monitoring.
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Allan Gordon, MD, PhD | XOMA (US) LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aurora | Colorado | United States | ||||
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| XOMA 358 single dose level B | Drug | XOMA 358 single dose level B administered by an intravenous infusion |
|
| XOMA 358 single dose level C | Drug | XOMA 358 single dose level C administered by an intravenous infusion |
|
| XOMA 358 multiple dose level 1 | Drug | XOMA 358 multiple dose level 1 administered by an intravenous infusion |
|
| Chicago |
| Illinois |
| United States |
| Baltimore | Maryland | United States |
| Boston | Massachusetts | United States |
| Rochester | Minnesota | United States |
| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000622674 | XOMA 358 |
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