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Completed

NCT Number: NCT01572012

Phase 1 Safety, Tolerability and PK Study of Ondansetron and Hylenex Recombinant 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.

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Key information

Conditions

Healthy

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Icon Development Solutions

San Antonio, Texas, 78209, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ondansetron

Drug

Ondansetron solution 4 mg single administration

Other names: Zofran

Ondansetron + Hylenex

Drug

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

Other names: Zofran

Zofran ODT

Drug

Zofran ODT (8 mg) single administration

Other names: ondansetron disintegrating tablet - oral

Ondansetron solution

Drug

Ondansetron solution (4 mg) single administration

Other names: Zofran

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Halozyme Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 5, 2012
Registry last updated
Jan 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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