Study to Characterize the Effect of Heparin on Palifermin Activity

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Swedish Orphan Biovitrum
• Treatments: Calcium heparin; Heparin

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.