Palifermin DDI (Drug Drug Interaction)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2006-07-31

Brief Summary

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The purpose of this study is to determine if Paliferim interacts with Heparin.

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Detailed Description

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Heparin has been shown to modulate binding of palifermin to the KGF receptor. Therefore, as part of a post-marketing regulatory commitment with the Food and Drug Administration (FDA), the purpose of this study is to characterize the potential pharmacokinetic and pharmacodynamic drug-drug interaction between a continuous IV infusion of heparin and an IV bolus injection of palifermin. If an interaction is observed during co-administration, it is expected that the outcome would be modulation of clearance of palifermin or a change in heparin activity. Although not commonly conducted, the literature describes heparin drug-drug interaction studies conducted in healthy subjects using both subcutaneous (Grimaudo et al,1988; Kroon et al, 1992) and intravenous (Caplain at al, 1999; Noveck \& Hubbard, 2004; Spowart et al, 1988) formulations. Based on these experiences, it is appropriate to investigate heparin drug-drug interactions in healthy subjects.

In this study, subjects will receive a single 60 mcg/kg dose of palifermin either as monotherapy or in conjunction with a continuous heparin infusion. The 60 mcg/kg dose of palifermin explored in this study is identical to the current recommended daily dosage for patients with hematologic malignancies who were undergoing autologous PBPC transplantation after receiving total body irradiation and high-dose chemotherapy: 3 consecutive days administered in two cycles with a 5-day non-dosing interval.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Palifermin

A single 60µg/kg IV bolus dose of palifermin on Day 1 of the treatment period

Group Type ACTIVE_COMPARATOR

Palifermin

Intervention Type DRUG

Palifermin + Heparin

A single 60µg/kg IV bolus dose of palifermin on Day 1 of the treatment period + unfractionated heparin for a 2 to 3 day heparin titation/maintenance period and continuing through a 3 day treatment period

Group Type EXPERIMENTAL

Palifermin

Intervention Type DRUG

Heparin

Intervention Type DRUG

Heparin

unfractionated heparin for a 2 to 3 day heparin titation/maintenance period and continuing through a 3 day treatment period

Group Type ACTIVE_COMPARATOR

Heparin

Intervention Type DRUG

Interventions

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Palifermin

Intervention Type DRUG

Heparin

Intervention Type DRUG

Other Intervention Names

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Kepivance

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: - Inclusion: Baseline aPTT values for all subjects must be within normal range. In addition, all subjects must also test negative for occult blood in the stool, have no history of bleeding disorders or no use of aspirin or NSAIDs within 14 days of study Day 1.

Exclusion Criteria

Exclusion Criteria: - Exclusion: The study will also exclude subjects who have any evidence or history of thrombocytopenia, heparin-induced thrombocytopenia or other contraindications to heparin (e.g., recent surgeries).

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes