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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8931-009 | Other Identifier | Schering -Plough |
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This study will assess the pharmacokinetics of MK-8931, a ß-secretase inhibitor, in participants with renal insufficiency. In Part 1 of the study, pharmacokinetics of MK-8931 in participants with severe renal disease and in healthy matched control participants will be studied. If data from Part 1 confirms that severe renal impairment does not alter the pharmacokinetics of MK-8931 to the extent requiring dosage adjustment, then no further study will be required and Part 2 will be optional. If the data does not support this conclusion, then Part 2 will be conducted to study the pharmacokinetics of MK-8931 in participants with moderate and mild renal impairment compared to healthy matched controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1, Panel A - Severe Renal Impairment Group | Experimental |
| |
| Part 1, Panel B - Healthy Control Group to Match Panel A | Experimental |
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| Part 2, Panel C - Moderate Renal Impairment Group | Experimental |
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| Part 2, Panel D - Healthy Control Group to Match Panel C | Experimental |
| |
| Part 2, Panel E - Mild Renal Impairment Group | Experimental |
| |
| Part 2, Panel F - Healthy Control Group to Match Panel E | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-8931 | Drug | Single dose, administered as oral capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of MK-8931 | Predose through 120 hours post single dose of MK-8931 |
| Measure | Description | Time Frame |
|---|---|---|
| Renal clearance (CLr) of MK-8931 | Predose through 120 hours post single dose of MK-8931 | |
| Fraction of MK-8931 dose excreted in urine (fe) | Predose through 120 hours post single dose of MK-8931 |
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Inclusion Criteria:
Inclusion Criteria Specific to Renally Impaired Participants:
Inclusion Criterion Specific to Healthy Participants:
Exclusion Criteria:
localized prostate carcinoma; or has undergone potentially curative therapy with no evidence of recurrence ≥1 year post-therapy
Exclusion Criteria Specific to Renally Impaired Participants:
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000613570 | verubecestat |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |