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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005267-32 | EudraCT Number |
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This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of eleclazine and its metabolite, GS-623134, in participants with normal and impaired renal function. Participants in the healthy control group will be matched to participants with impaired renal function by age (± 5 years), gender, and body mass index (± 10%).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild Renal Impairment (CLcr 60-89 mL/min) | Experimental | Participants with mild renal impairment and matched control participants with normal renal function will receive a single dose of eleclazine 30 mg (5 x 6 mg tablets). |
|
| Moderate Renal Impairment (CLcr 30-59 mL/min) | Experimental | Participants with moderate impairment and matched control participants with normal renal function will receive a single dose of eleclazine 30 mg (5 x 6 mg tablets). |
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| Severe Renal Impairment (CLcr 15-29 mL/min) | Experimental | Participants with severe renal impairment and matched control participants with normal renal function will receive a single dose of eleclazine 30 mg (5 x 6 mg tablets). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eleclazine | Drug | Eleclazine tablets administered orally in morning with food |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma pharmacokinetics (PK) profiles of eleclazine and its metabolite GS-623134: AUC_0-inf and Cmax | This endpoint will measure the plasma PK profiles of eleclazine and GS-623134. PK parameters that will be measured include AUC_0-inf and Cmax. | Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24, 36, 48, 72, 96, 120 hours, 15, 29, 43, and 57 days postdose on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety profile of eleclazine as measured by incidence of adverse events and laboratory abnormalities | Up to 58 days |
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Inclusion Criteria:
All Individuals:
Individuals with mild, moderate, or severe renal impairment must also meet the following additional inclusion criteria to be eligible for participation in this study:
Individuals with normal renal function must also meet the following additional inclusion criteria to be eligible for participation in this study:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian McNabb, MD | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DeLand | Florida | United States | ||||
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| ID | Term |
|---|---|
| D008133 | Long QT Syndrome |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
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| ID | Term |
|---|---|
| C000624281 | eleclazine |
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|
| Miami |
| Florida |
| United States |
| Orlando | Florida | United States |
| Saint Paul | Minnesota | United States |
| Kansas City | Missouri | United States |
| Chisinau | Moldova |
| Bucharest | Romania |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |