Healthy
Conditions
Keywords
Pharmacokinetics, Safety, Healthy Volunteers, tolerability
Brief 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.
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
DRUGOndansetron
Ondansetron solution 4 mg single administration
DRUGOndansetron + Hylenex
Ondansetron solution (4 mg) single administration + Hylenex recombinant (150 U) single administration
DRUGZofran ODT
Zofran ODT (8 mg) single administration
DRUGOndansetron solution
Ondansetron solution (4 mg) single administration
Sponsors
Halozyme Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Overall Safety | 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Pharmacokinetics | 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 |
Countries
United States
Outcome results
None listed