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

NCT01572012 | Completed Phase 1

• 1 other identifier: HALO-102-102
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Pharmacokinetics; Safety; Healthy Volunteers; tolerability

Outcome Measures

Primary Outcomes (1)

• Evaluation of Overall Safety

  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

  Days 1-31

Secondary Outcomes (1)

• Evaluation of Pharmacokinetics

  Days 1-5

Study Arms (4)

Subcutaneous Administration

EXPERIMENTAL

Ondansetron + Hylenex administered subcutaneously

Drug: Ondansetron + Hylenex

Oral Administration

EXPERIMENTAL

Ondansetron administered orally

Drug: Zofran ODT

Intramuscular Administration

EXPERIMENTAL

Ondansetron administered intramuscularly

Drug: Ondansetron

Intravenous Administration

EXPERIMENTAL

Ondansetron administered intravenously

Drug: Ondansetron solution

Interventions

Ondansetron DRUG

Ondansetron solution 4 mg single administration

Also known as: Zofran

Intramuscular Administration

Ondansetron + Hylenex DRUG

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

Also known as: Zofran

Subcutaneous Administration

Zofran ODT DRUG

Zofran ODT (8 mg) single administration

Also known as: ondansetron disintegrating tablet - oral

Oral Administration

Ondansetron solution DRUG

Ondansetron solution (4 mg) single administration

Also known as: Zofran

Intravenous Administration

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Halozyme Therapeutics: lead

Study Sites (1)

Icon Development Solutions

San Antonio, Texas, 78209, United States

Location

Related Publications (1)

• 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.

  PMID: 24486335 DERIVED

MeSH Terms

Interventions

Ondansetron

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Samuel S Dychter, MD

  Halozyme Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2012
• First Posted: April 5, 2012
• Study Start: February 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: January 24, 2014

Record last verified: 2014-01

Locations

US (1)