Status:
COMPLETED
Study to Characterize the Effect of Heparin on Palifermin Activity
Lead Sponsor:
Swedish Orphan Biovitrum
Conditions:
Oral Mucositis
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the effect of a continuous intravenous infusion of unfractionated heparin on the multiple-dose pharmacodynamics of palifermin in healthy adult subjects.
Detailed Description
The planned study is designed to characterize the impact of heparin on the biologic activity of palifermin and assess the impact of the combination of palifermin and heparin on tolerability. Approxima...
Eligibility Criteria
Inclusion
- Healthy men or postmenopausal or oophorectomized women.
- Subjects should have a Body Mass Index between 19 and 30 inclusive.
- A negative screen for drug abuse, tobacco use and alcohol breath test.
- Subjects should be willing to be resident in the research facility for up to 6 nights and return to the research facility for scheduled study and follow-up procedures.
- Men must agree for the duration of the study to use an appropriate method of birth control
Exclusion
- History or evidence of clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
- History or evidence of any oral mucosal disease that may affect mucosal keratinocyte proliferation.
- Evidence or history of thrombocytopenia, heparin-induced thrombocytopenia or other contraindications to heparin (e.g. recent surgeries).
- Known hypersensitivity to heparin or topical or injectable local anesthetic.
- Known allergies to Escherichia coli-derived products or allergies to palifermin or its excipients.
- Use of medications (except vitamins, hormonal replacement therapy and topical medications) within 10 days of admission to research facility.
- Blood donation within 8 weeks prior to dosing of investigational drug.
- History of hypertension, clinically significant bleeding, gastrointestinal ulcers, arteriovenous malformation (AVM), aneurysm, or other vascular malformation.
- History of coagulopathy, bleeding disorders or abnormal platelet counts.
- History of malignancy of any type, other than surgically excised non-melanoma skin cancers or in situ cervical cancer.
- For males, past history of epididymitis.
- Known alcohol abuse or use of illicit drugs within 12 months prior to admission to the research facility.
- History of smoking or using smokeless tobacco within the past year before admission to the research facility.
- Any other condition that might reduce the chance of obtaining data (eg, known poor compliance) required by the protocol or that might compromise the ability to give informed consent.
- Previous participation in a palifermin study.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01163097
Start Date
July 1 2010
End Date
January 1 2011
Last Update
November 6 2014
Active Locations (1)
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1
New Orleans Center for Clinical Research (NOCCR)
Knoxville, Tennessee, United States, 37920