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This is a randomized, open-label Phase 1 pharmacokinetic, tolerability, and safety study of ondansetron and Hylenex given subcutaneously compared to ondansetron given intravenously, intramuscularly, and orally in normal healthy volunteers.
This is a randomized, open label, 4 way crossover Phase 1 study of the pharmacokinetics, safety and tolerability of a 4 mg dose of ondansetron administered subcutaneously with Hylenex recombinant compared to 4 mg doses of ondansetron administered intravenously and intramuscularly and an 8 mg dose of ondansetron administered orally.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subcutaneous Administration | Experimental | Ondansetron + Hylenex administered subcutaneously |
|
| Oral Administration | Experimental | Ondansetron administered orally |
|
| Intramuscular Administration | Experimental | Ondansetron administered intramuscularly |
|
| Intravenous Administration | Experimental | Ondansetron administered intravenously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ondansetron | Drug | Ondansetron solution 4 mg single administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Overall Safety | Investigator assessment of infusion site observations for parenteral administration; Subject assessment of pain using the verbal response scale for parenteral administration; Subject assessment of pain using the visual analog scale for parenteral administration; Investigator assessment of systemic adverse events | Days 1-31 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Pharmacokinetics | Area of under the plasma concentration time curve (AUC); Time to achieve maximum plasma concentration (tmax); Maximum plasma concentration (Cmax); Plasma elimination half-life (t1/2); Relative bioavailability, ondansentron SC with Hylenex recombinant relative to ondansetron alone IV, IM, and PO | Days 1-5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel S Dychter, MD | Halozyme Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icon Development Solutions | San Antonio | Texas | 78209 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24486335 | Derived | Dychter SS, Harrigan R, Bahn JD, Printz MA, Sugarman BJ, DeNoia E, Haughey DB, Fellows D, Maneval DC. Tolerability and pharmacokinetic properties of ondansetron administered subcutaneously with recombinant human hyaluronidase in minipigs and healthy volunteers. Clin Ther. 2014 Feb 1;36(2):211-24. doi: 10.1016/j.clinthera.2013.12.013. Epub 2014 Jan 31. |
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| ID | Term |
|---|---|
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Ondansetron + Hylenex | Drug | Ondansetron solution (4 mg) single administration + Hylenex recombinant (150 U) single administration |
|
|
| Zofran ODT | Drug | Zofran ODT (8 mg) single administration |
|
|
| Ondansetron solution | Drug | Ondansetron solution (4 mg) single administration |
|
|
| D002227 |
| Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |