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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01572012
Recruitment Status : Completed
First Posted : April 5, 2012
Last Update Posted : January 24, 2014
Information provided by (Responsible Party):
Halozyme Therapeutics

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Ondansetron Drug: Ondansetron + Hylenex Drug: Zofran ODT Drug: Ondansetron solution Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Subcutaneous Administration
Ondansetron + Hylenex administered subcutaneously
Drug: Ondansetron + Hylenex
Ondansetron solution (4 mg) single administration + Hylenex recombinant (150 U) single administration
Other Name: Zofran
Experimental: Oral Administration
Ondansetron administered orally
Drug: Zofran ODT
Zofran ODT (8 mg) single administration
Other Name: ondansetron disintegrating tablet - oral
Experimental: Intramuscular Administration
Ondansetron administered intramuscularly
Drug: Ondansetron
Ondansetron solution 4 mg single administration
Other Name: Zofran
Experimental: Intravenous Administration
Ondansetron administered intravenously
Drug: Ondansetron solution
Ondansetron solution (4 mg) single administration
Other Name: Zofran

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01572012

United States, Texas
Icon Development Solutions
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Halozyme Therapeutics
Study Director: Samuel S Dychter, MD Halozyme Therapeutics

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Halozyme Therapeutics Identifier: NCT01572012     History of Changes
Other Study ID Numbers: HALO-102-102
First Posted: April 5, 2012    Key Record Dates
Last Update Posted: January 24, 2014
Last Verified: January 2014

Keywords provided by Halozyme Therapeutics:
Healthy Volunteers

Additional relevant MeSH terms:
Pharmaceutical Solutions
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents