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: January 22, 2014
Last verified: January 2014

April 3, 2012
January 22, 2014
February 2012
November 2013   (final data collection date for primary outcome measure)
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
Evaluate PK profile of ondansetron plus HYLENEX administered subcutaneously compared to IM, IV and PO administrations of ondansetron [ Time Frame: Days 1, 2, 3 and 4 ] [ Designated as safety issue: No ]
Conduct intensive PK sampling on each dosing day
Complete list of historical versions of study NCT01572012 on ClinicalTrials.gov Archive Site
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
Evaluation of overall safety. [ Time Frame: Screening, Days 1-5, Day 11 and Day 31 ] [ Designated as safety issue: No ]
Safety assessments include infusion site assessments, physical exams, routine labs, ECGs and adverse events.
Not Provided
Not Provided
 
Phase 1 Safety, Tolerability and PK Study of Ondansetron and Hylenex Recombinant in Healthy Volunteers
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • Drug: Ondansetron
    Ondansetron solution 4 mg single administration
    Other Name: Zofran
  • Drug: Ondansetron + Hylenex
    Ondansetron solution (4 mg) single administration + Hylenex recombinant (150 U) single administration
    Other Name: Zofran
  • Drug: Zofran ODT
    Zofran ODT (8 mg) single administration
    Other Name: ondansetron disintegrating tablet - oral
  • Drug: Ondansetron solution
    Ondansetron solution (4 mg) single administration
    Other Name: Zofran
  • Experimental: Subcutaneous Administration
    Ondansetron + Hylenex administered subcutaneously
    Intervention: Drug: Ondansetron + Hylenex
  • Experimental: Oral Administration
    Ondansetron administered orally
    Intervention: Drug: Zofran ODT
  • Experimental: Intramuscular Administration
    Ondansetron administered intramuscularly
    Intervention: Drug: Ondansetron
  • Experimental: Intravenous Administration
    Ondansetron administered intravenously
    Intervention: Drug: Ondansetron solution
Dychter SS, Harrigan R, Bahn JD, Printz MA, Sugarman BJ, DeNoia E, Haughey DB, Fellows D, Maneval DC. Tolerability and pharmacokinetic properties of ondansetron administered subcutaneously with recombinant human hyaluronidase in minipigs and healthy volunteers. Clin Ther. 2014 Feb 1;36(2):211-24. doi: 10.1016/j.clinthera.2013.12.013. Epub 2014 Jan 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
November 2013
November 2013   (final data collection date for primary outcome measure)

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
Both
19 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01572012
HALO-102-102
No
Halozyme Therapeutics
Halozyme Therapeutics
Not Provided
Study Director: Samuel S Dychter, MD Halozyme Therapeutics
Halozyme Therapeutics
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP