NCT01572012

Phase 1 Safety, Tolerability and PK Study of Ondansetron and Hylenex Recombinant in Healthy Volunteers

Phase 1 Open-Label Randomized 4 Period Crossover Study Comparing Safety, Tolerability and PK of Ondansetron Given Subcutaneously With Hylenex Recombinant and Given Alone Intramuscularly, Intravenously and Orally in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Halozyme Therapeutics · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ondansetron	Ondansetron solution 4 mg single administration
DRUG	Ondansetron + Hylenex	Ondansetron solution (4 mg) single administration + Hylenex recombinant (150 U) single administration
DRUG	Zofran ODT	Zofran ODT (8 mg) single administration
DRUG	Ondansetron solution	Ondansetron solution (4 mg) single administration

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2012-04-05
• Last updated: 2014-01-24

Locations

1 site across 1 country: United States