Study to Characterize the Effect of Heparin on Palifermin Activity

Completed · Phase 1

Conditions studied: Oral Mucositis

In brief

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.

Key facts

Study ID

NCT01163097

Run by

Swedish Orphan Biovitrum

People needed

44

Starts

2010-07-01

Expected to finish

2011-01-01

Last updated by the study team

2014-11-06

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• New Orleans Center for Clinical Research (NOCCR) — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.