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

Halozyme

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Zofran ODT; Drug: Ondansetron; Drug: Ondansetron + Hylenex; Drug: Ondansetron solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01572012

HALO-102-102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

Subcutaneous Administration

Experimental group

Description:

Ondansetron + Hylenex administered subcutaneously

Treatment:

Drug: Ondansetron + Hylenex

Oral Administration

Experimental group

Description:

Ondansetron administered orally

Treatment:

Drug: Zofran ODT

Intramuscular Administration

Experimental group

Description:

Ondansetron administered intramuscularly

Treatment:

Drug: Ondansetron

Intravenous Administration

Experimental group

Description:

Ondansetron administered intravenously

Treatment:

Drug: Ondansetron solution