Study to Characterize the Effect of Heparin on Palifermin Activity
Condition: Oral Mucositis
MeSH terms: Mucositis; Stomatitis
Intervention: Palifermin; Heparin
Intervention description: 40 µg/kg IV bolus injections for three consecutive days; Heparin continuous IV infusion
Intervention MeSH terms: Heparin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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.