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

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.

Inclusion Criteria:

• Male or female volunteers 19-65 years old
• Females must be nonlactating and nonpregnant (negative serum pregnancy test at screening)and agree to practice effective birth control for at least 30 days after study completion
• Nonsmoker or no tobacco/nicotine use in previous 6 months
• Intact normal skin without obscuring tattoos, pigmentation or lesions
• Adequate venous access in upper extremities
• Normal vital signs, ECG, and labs or assessed by the Investigator as NCS
• Serum hemoglobin within site's normal range
• Negative drug and alcohol screen
• Able to make decisions and comply with study requirements

Exclusion Criteria:

• History of drug or alcohol abuse or positive drug and alcohol screen
• Abdominal surgery within the last 30 days
• Phenylketonuria
• Tobacco or nicotine use within previous 6 months
• Hypersensitivity or contraindication to ondansetron or other 5-HT3 receptor agonists
• Received ondansetron within 4 days prior to Day 1
• Known allergy to hyaluronidase or other ingredient in Hylenex recombinant
• Lower extremity edema
• Creatinine clearance < 60 mL/min
• Dehydration (Grade 2 or higher)
• Hypersensitivity or contraindication to heparin
• Abnormal ECG with clinically significant QT prolongation or history of
• Female who is pregnant or breastfeeding
• Participation in a clinical trial (drug or device) within 30 days of enrollment
• Clinically significant medical history, major systemic disease, intercurrent illness, physical examination finding, or clinical laboratory test result that risks the subject's safety or interfere with interpretation of study results
• Not able to comply with study requirements