Study to Characterize the Effect of Heparin on Palifermin Activity

Sobi

Status and phase: Completed; Phase 1

Conditions: Oral Mucositis

Treatments: Drug: Palifermin; Drug: Heparin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01163097

20070278

Details and patient eligibility

About

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.

Full 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. Approximately forty-three (43) eligible healthy adult men and oophorectomized or postmenopausal women between 18-45 years of age will be assigned to one of three treatment groups where treatment group A will receive a daily dose of palifermin 40 µg/kg for three consecutive days as intravenous (IV) bolus injections and continuous heparin IV infusion, treatment B will receive a daily dose of palifermin 40 µg/kg for three consecutive days as IV bolus injections and treatment C will be a control group without any treatment administered. The subjects will be randomized in a 20:15:8 ratio (Treatment A:B:C).

The study consists of a up to 21-days screening period, a 5-days treatment period and a up to 45-days follow-up period.

Enrollment: 44 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 3 patient groups

Palifermin 40 µg/kg and heparin IV infusion

Experimental group

Description:

Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion

Treatment:

Drug: Heparin

Drug: Palifermin

Palifermin 40 µg/kg

Experimental group

Description:

Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections

Treatment:

Drug: Palifermin

Control group without any treatment

No Intervention group

Description:

Treatment C: control group without any treatment administered.