Phase 1 Safety, Tolerability and PK Study of Ondansetron and Hylenex Recombinant in Healthy Volunteers
Information source: Halozyme Therapeutics
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Ondansetron (Drug); Ondansetron + Hylenex (Drug); Zofran ODT (Drug); Ondansetron solution (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Halozyme Therapeutics Official(s) and/or principal investigator(s):
Samuel S Dychter, MD, Study Director, Affiliation: Halozyme Therapeutics
Overall contact:
Rena Harrigan, Phone: 858-704-8168, Email: rharrigan@halozyme.com
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Evaluation of Overall Safety
Secondary outcome: Evaluation of Pharmacokinetics
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.
Eligibility
Minimum age: 19 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Rena Harrigan, Phone: 858-704-8168, Email: rharrigan@halozyme.com
Icon Development Solutions, San Antonio, Texas 78209, United States; Recruiting
ICON, Phone: 210-225-5437
Emanuel P DeNoia, MD, Principal Investigator
Additional Information
Starting date: February 2012
Last updated: April 9, 2012
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