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| ID | Type | Description | Link |
|---|---|---|---|
| 64294178HPC1009 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of AL-335 in participants with various degrees of impaired renal function (mild, moderate, and severe) compared to participants with normal renal function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AL-335 (Cohort 1) | Experimental | Participants with mild impaired renal function will receive a single oral dose of AL-335 800 milligram (mg) (given as 2*400-mg tablets). |
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| AL-335 (Cohort 2) | Experimental | Participants with moderate impaired renal function will receive a single oral dose of AL-335 800 mg (given as 2*400-mg tablets). |
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| AL-335 (Cohort 3) | Experimental | Participants with severe impaired renal function will receive a single oral dose of AL-335 800 mg (given as 2*400-mg tablets). |
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| AL-335 (Cohort 4) | Experimental | Participants with normal renal function will receive a single oral dose of AL-335 800 mg (given as 2*400-mg tablets). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AL-335 | Drug | Participants with various degrees of impaired renal function (mild [Cohort 1], moderate [Cohort 2], severe [Cohort 3]) and normal renal function (Cohort 4) will receive a single oral dose of AL-335 800 mg (given as 2*400-mg tablets). |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of AL-335 | The Cmax is the maximum observed concentration of analyte (AL-335). | Pre-dose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 28, 32, 36, 48, 60, and 72 hours post-dose |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | The AUClast is the area under the analyte (AL-335) concentration-time curve from time zero (0) to time of the last quantifiable concentration. | Pre-dose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 28, 32, 36, 48, 60, and 72 hours post-dose |
| Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUCinfinity) | The AUCinfinity is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant. | Pre-dose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 28, 32, 36, 48, 60, and 72 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Up to follow-up (Approximately 30-35 days after study drug administration) |
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Inclusion Criteria:
Cohorts 1-4:
Cohorts 1-3:
Cohort 4:
Exclusion Criteria:
Cohorts 1-4:
Cohorts 1-3:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando | Florida | United States | ||||
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000629483 | adafosbuvir |
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| Knoxville |
| Tennessee |
| United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |