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The purpose of this study is to determine the effect of renal impairment on rivipansel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild Renal Impairment | Experimental | A single dose of IV Rivipansel over 20 minutes |
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| Moderate Renal Impairment | Experimental | A single dose of IV Rivipansel over 20 minutes |
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| Severe Renal Impairment | Experimental | A single dose of IV Rivipansel over 20 minutes |
|
| Normal Renal Functions | Experimental | A single dose of IV Rivipansel over 20 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivipansel | Drug | A single 840mg dose of Rivipansel over 20 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve from time 0 to infinity or area under the concentration-time curve from time 0 to the time of the last quantifiable concentration, as data permit | Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration | |
| Clearance (CL) | Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration | |
| Renal clearance | Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration | |
| Physical examination | Baseline up to 96 hours | |
| Assessment of adverse events | Baseline up to 28 days | |
| Assessment of 12-lead electrocardiograms | Baseline up to 96 hours | |
| Assessment of vital signs | Baseline up to 96 hours | |
| Assessment of laboratory tests | Baseline up to 96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration | Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration | |
| Peak or maximum observed concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | United States | ||
| Avail Clinical Research, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32579796 | Derived | Tammara BK, Ryan K, Plotka A, Shafer FE, Wei H, Readett D, Fang A, Korth-Bradley JM. Effect of Renal or Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Intravenous Rivipansel. Clin Pharmacol Drug Dev. 2020 Nov;9(8):918-928. doi: 10.1002/cpdd.842. Epub 2020 Jun 24. |
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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 |
|---|---|
| C553182 | rivipansel |
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| Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration |
| Time to reach maximum concentration | Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration |
| Terminal half life | Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration |
| Apparent volume of distribution | Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration |
| Amount of unchanged drug excreted into urine over 96 hours | Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration |
| Percentage of dose excreted unchanged into urine over 96 hours | Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration |
| Fraction of unbound | Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration |
| DeLand |
| Florida |
| 32720 |
| United States |
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |