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The purpose of this study is to evaluate the effect of age on PK, safety and tolerability of IV rivipansel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aged 18-45 years | Experimental | A single dose of IV rivipansel over 20 minutes. |
|
| Aged 65 and older | Experimental | A single dose of IV rivipansel over 20 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivipansel | Drug | A single dose of IV rivipansel over 20 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time profile from time 0 extrapolated to infinite time or area under the plasma concentration-time from time 0 to 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 and 72 hours following single dose administration of IV rivipansel | |
| Clearance (CL) | Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48 and 72 hours following single dose administration of rivipansel. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time profile from time 0 to time of last quantifiable concentration | Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48 and 72 hours following single dose administration of rivipansel. | |
| Maximum plasma concentration |
| Measure | Description | Time Frame |
|---|---|---|
| Banked Biospecimen | Day 0 |
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 |
|---|---|---|---|---|---|---|
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
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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 and 72 hours following single dose administration of rivipansel. |
| Mean elimination half-life | Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48 and 72 hours following single dose administration of rivipansel. |
| Volume of distribution at steady state | Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48 and 72 hours following single dose administration of rivipansel. |
| Physical examination | Baseline up to 72 hours |
| Assessment of adverse events | Baseline up to 28 days |
| Assessment of 12-lead electrocardiogram | Baseline up to 72 hours |
| Assessment of vital signs | Baseline up to 72 hours |
| Assessment of laboratory tests | Baseline up to 72 hours |