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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Subcutaneous Administration

Ondansetron + Hylenex administered subcutaneously

Group Type EXPERIMENTAL

Ondansetron + Hylenex

Intervention Type DRUG

Ondansetron solution (4 mg) single administration + Hylenex recombinant (150 U) single administration

Oral Administration

Ondansetron administered orally

Group Type EXPERIMENTAL

Zofran ODT

Intervention Type DRUG

Zofran ODT (8 mg) single administration

Intramuscular Administration

Ondansetron administered intramuscularly

Group Type EXPERIMENTAL

Ondansetron

Intervention Type DRUG

Ondansetron solution 4 mg single administration

Intravenous Administration

Ondansetron administered intravenously

Group Type EXPERIMENTAL

Ondansetron solution

Intervention Type DRUG

Ondansetron solution (4 mg) single administration

Interventions

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Ondansetron

Ondansetron solution 4 mg single administration

Intervention Type DRUG

Ondansetron + Hylenex

Ondansetron solution (4 mg) single administration + Hylenex recombinant (150 U) single administration

Intervention Type DRUG

Zofran ODT

Zofran ODT (8 mg) single administration

Intervention Type DRUG

Ondansetron solution

Ondansetron solution (4 mg) single administration

Intervention Type DRUG

Other Intervention Names

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Zofran Zofran ondansetron disintegrating tablet - oral Zofran

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes