Phase 1 Safety, Tolerability and PK Study of Ondansetron and Hylenex Recombinant in Healthy Volunteers
Overview
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.
Full Title of Study: “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 Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: November 2013
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.
Interventions
- Drug: Ondansetron
- Ondansetron solution 4 mg single administration
- Drug: Ondansetron + Hylenex
- Ondansetron solution (4 mg) single administration + Hylenex recombinant (150 U) single administration
- Drug: Zofran ODT
- Zofran ODT (8 mg) single administration
- Drug: Ondansetron solution
- Ondansetron solution (4 mg) single administration
Arms, Groups and Cohorts
- Experimental: Subcutaneous Administration
- Ondansetron + Hylenex administered subcutaneously
- Experimental: Oral Administration
- Ondansetron administered orally
- Experimental: Intramuscular Administration
- Ondansetron administered intramuscularly
- Experimental: Intravenous Administration
- Ondansetron administered intravenously
Clinical Trial Outcome Measures
Primary Measures
- Evaluation of Overall Safety
- Time Frame: Days 1-31
- Investigator assessment of infusion site observations for parenteral administration; Subject assessment of pain using the verbal response scale for parenteral administration; Subject assessment of pain using the visual analog scale for parenteral administration; Investigator assessment of systemic adverse events
Secondary Measures
- Evaluation of Pharmacokinetics
- Time Frame: Days 1-5
- Area of under the plasma concentration time curve (AUC); Time to achieve maximum plasma concentration (tmax); Maximum plasma concentration (Cmax); Plasma elimination half-life (t1/2); Relative bioavailability, ondansentron SC with Hylenex recombinant relative to ondansetron alone IV, IM, and PO
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 19 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Halozyme Therapeutics
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Samuel S Dychter, MD, Study Director, Halozyme Therapeutics
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