Phase 1 Safety, Tolerability and PK Study of Ondansetron and Hylenex Recombinant in Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 19 - 65 |
| Updated: | 3/30/2013 |
| Start Date: | February 2012 |
| End Date: | July 2012 |
| Contact: | Rena Harrigan |
| Email: | rharrigan@halozyme.com |
| Phone: | 858-704-8168 |
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.
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
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