Clinical trial NCT01572012: Phase 1 Safety, Tolerability and PK Study of Ondansetron and Hylenex Recombinant in Healthy Volunteers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Pharmacokinetics
Safety
Healthy Volunteers
tolerability
Lead sponsor: Halozyme Therapeutics
Sponsor class: INDUSTRY
First posted: 2012-04-05
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Evaluation of Overall Safety
timeFrame: Days 1-31
Secondary outcomes:
measure: Evaluation of Pharmacokinetics
timeFrame: Days 1-5
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Icon Development Solutions
state: Texas
Study officials:
affiliation: Halozyme Therapeutics
name: Samuel S Dychter, MD
role: STUDY_DIRECTOR
References:
citation: 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.