Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002748-41 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a 2 part study designed to provide an initial assessment on the safety, tolerability, and PK of rivipansel, following single ascending (Part 1) and multiple ascending dosing (Part 2) given subcutaneously with rHuPH20, in healthy subjects. Part 1 of the study will be conducted using a cross-over design while Part 2 of the study will be conducted using a parallel design.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Single ascending dose in 3 period cross-over design (with optional 4th period) |
|
| Cohort 2 | Experimental | Multiple ascending dose |
|
| Cohort 3 | Experimental | Multiple ascending dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivipansel | Drug | Rivipansel administered as a single dose subcutaneously with rHuPH20 in cross-over fashion. Each subject may receive up to 4 study treatments (placebo and up to 3 doses of rivipansel). The planned dose levels are 350 mg, 1210 mg, and 4200 mg (these are subject to change based on emerging data). |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of adverse events (AEs) | Baseline up to 7 days of dosing | |
| Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG) | Baseline up to 7 days of dosing | |
| Assessment of vital signs (including blood pressure and pulse rate) | Baseline up to 7 days of dosing | |
| Assessment of clinical laboratory tests | Baseline up to 7 days of dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) for rivipansel following single dose | Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for rivipansel following single dose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit | Brussels | B-1070 | Belgium |
Not provided
| ID | Term |
|---|---|
| C553182 | rivipansel |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | Matched Placebo administered as single dose subcutaneously with rHuPH20. |
|
| Rivipansel | Drug | Rivipansel administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20. Planned doses are 1400 mg loading and 700 mg maintenance for 12 doses (these are subject to change based on emerging data). |
|
| Rivipansel | Drug | Rivipansel administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20. Planned doses are 2800 mg loading and 1400 mg maintenance for 12 doses (these are subject to change based on emerging data). |
|
| Placebo | Drug | Matched Placebo administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20. |
|
| Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for rivipansel following single dose | Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for rivipansel following single dose | Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration |
| Dose-Normalized Cmax for rivipansel following single dose | Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration |
| Dose-Normalized AUClast for rivipansel | Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration |
| Dose-Normalized AUCinf for rivipansel | Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration |
| Plasma Decay Half-Life (t1/2) for rivipansel following single dose | Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration |
| Apparent Clearance (CL/F) for rivipansel following single dose | Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration |
| Apparent Volume of Distribution (Vz/F) for rivipansel following single dose | Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration |
| Maximum Observed Plasma Concentration (Cmax) for rivipansel following multiple dose | Days 1, 7 |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for rivipansel following multiple dose | Days 1, 7 |
| Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for rivipansel following multiple dose administration, where tau is 12 hours | Days 1, 7 |
| Dose-Normalized Cmax for rivipansel following multiple dose administration | Days 1, 7 |
| Dose-Normalized AUCtau for rivipansel following multiple dose administration | Days 1, 7 |
| Plasma Decay Half-Life (t1/2) for rivipansel following multiple dose | Day 7 |
| Minimum Observed Plasma Concentration (Cmin) for rivipansel following multiple dose | Day 7 |
| Apparent Clearance (CL/F) for rivipansel following multiple dose | Day 7 |
| Peak to Trough Ratio (PTR) of plasma concentration for rivipanselmultiple dose administration | Day 7 |
| Accumulation ratio for Area Under the Curve during the dosing interval (Rac) for rivipansel | Day 7 |