Palifermin DDI (Drug Drug Interaction)

An Open-label, Randomized, 2-part, Parallel Design Study to Characterize the Effect of Heparin on Palifermin Pharmacokinetics and the Effect of Palifermin on Heparin Pharmacodynamics in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00361348

Enrollment

Registered

2006-08-08

Start date

2005-12-31

Completion date

2006-07-31

Last updated

2014-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Palifermin, drug interaction

Brief summary

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

Detailed description

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.

Interventions

DRUGPalifermin

DRUGHeparin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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: 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).

Design outcomes

Primary

Measure	Time frame
To evaluate the effect of a continuous intravenous (IV) infusion of unfractionated heparin on the single-dose pharmacokinetics (PK) of palifermin in healthy subjects.	—

Secondary

Measure	Time frame
To evaluate the effect (activated partial thromboplastin time, aPTT) of a single dose of palifermin on unfractionated heparin pharmacodynamics [(PD), AUCaPTT, 0-6, AUCaPTT, 0-24].	—
To evaluate the safety and tolerability of a single 60 µg/kg intravenous dose of palifermin with or without a continuous IV infusion of heparin.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026