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

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Halozyme Therapeutics
• Treatments: Ondansetron; Pharmaceutical Solutions

Criteria

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