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

January 22, 2014 updated by: Halozyme Therapeutics

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78209
        • ICON Development Solutions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Zofran
EXPERIMENTAL: Oral Administration
Ondansetron administered orally
Drug: Zofran ODT
Zofran ODT (8 mg) single administration
Other Names:
  • ondansetron disintegrating tablet - oral
EXPERIMENTAL: Intramuscular Administration
Ondansetron administered intramuscularly
Drug: Ondansetron
Ondansetron solution 4 mg single administration
Other Names:
  • Zofran
EXPERIMENTAL: Intravenous Administration
Ondansetron administered intravenously
Drug: Ondansetron solution
Ondansetron solution (4 mg) single administration
Other Names:
  • Zofran

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Days 1-31

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Days 1-5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Halozyme Therapeutics

Investigators

  • Study Director: Samuel S Dychter, MD, Halozyme Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

April 3, 2012

First Submitted That Met QC Criteria

April 4, 2012

First Posted (ESTIMATE)

April 5, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 24, 2014

Last Update Submitted That Met QC Criteria

January 22, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HALO-102-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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