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

Information source: Halozyme Therapeutics
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Ondansetron (Drug); Ondansetron + Hylenex (Drug); Zofran ODT (Drug); Ondansetron solution (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Halozyme Therapeutics

Official(s) and/or principal investigator(s):
Samuel S Dychter, MD, Study Director, Affiliation: Halozyme Therapeutics

Overall contact:
Rena Harrigan, Phone: 858-704-8168, Email: rharrigan@halozyme.com

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Evaluation of Overall Safety

Secondary outcome: Evaluation of Pharmacokinetics

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

Minimum age: 19 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Rena Harrigan, Phone: 858-704-8168, Email: rharrigan@halozyme.com

Icon Development Solutions, San Antonio, Texas 78209, United States; Recruiting
ICON, Phone: 210-225-5437
Emanuel P DeNoia, MD, Principal Investigator
Additional Information

Starting date: February 2012
Last updated: April 9, 2012

Page last updated: February 07, 2013

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