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

NCT01572012 ↗

Phase 1 Completed 12 enrolled Halozyme Therapeutics

RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start: 2012-02
Primary completion: 2013-11
Completion: 2013-11

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ondansetron	Other / unclassified	4 mg	Subcutaneous
Subject	Ondansetron	Other / unclassified	8 mg	Subcutaneous
Subject	rHuPH20	Protein / enzyme biologic	150 iu	Subcutaneous

Indications

No indication recorded.