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

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01572012

Run by

Halozyme Therapeutics

People needed

12

Starts

2012-02-01

Expected to finish

2013-11-01

Last updated by the study team

2014-01-24

Who can join

Age: 19 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Icon Development Solutions — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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