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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Halozyme Therapeutics
ClinicalTrials.gov Identifier:
NCT01572012
First received: April 3, 2012
Last updated: April 2, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention Phase
Healthy
 Drug: Ondansetron
Drug: Ondansetron + Hylenex
Drug: Zofran ODT
Drug: Ondansetron solution
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Halozyme Therapeutics:

Primary Outcome Measures:
  • Evaluation of Overall Safety [ Time Frame: Days 1-31 ] [ Designated as safety issue: No ]
    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:
  • Evaluation of Pharmacokinetics [ Time Frame: Days 1-5 ] [ Designated as safety issue: No ]
    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


Enrollment: 12
Study Start Date: February 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01572012

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

No publications provided

Responsible Party: Halozyme Therapeutics
ClinicalTrials.gov Identifier: NCT01572012     History of Changes
Other Study ID Numbers: HALO-102-102
Study First Received: April 3, 2012
Last Updated: April 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Halozyme Therapeutics:
Pharmacokinetics
Safety
Healthy Volunteers
tolerability

Additional relevant MeSH terms:
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipruritics
 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

ClinicalTrials.gov processed this record on May 16, 2013