Back to resultsStudy to Characterize the Effect of Heparin on Palifermin Activity
Primary Purpose
Oral Mucositis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Palifermin
Heparin
Sponsored by
About this trial
This is an interventional treatment trial for Oral Mucositis
Eligibility 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.
Sites / Locations
- New Orleans Center for Clinical Research (NOCCR)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Palifermin 40 µg/kg and heparin IV infusion
Palifermin 40 µg/kg
Control group without any treatment
Arm Description
Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
Treatment C: control group without any treatment administered.
Outcomes
Primary Outcome Measures
Ratio to Baseline of Epithelial Cell Proliferation as Assessed by Ki67 Staining of Buccal Mucosal Tissue.
This outcome is a measure of the palifermin effect on the buccal mucosal cells. Ki67 is a measure of proliferation of cells in the buccal mucosa. This measure assess the number of cells per millimeter (mm) before and after palifermin treatment.
Incidence of Grade 2 or Higher Specific Skin-related Adverse Events.
Incidence of grade 2 or higher specific skin-related treatment emergent adverse events following palifermin administration was calculated for subjects in treatment groups A and B. Incidence was calculated by treatment as number of subjects with grade 2 or higher specific skin-related AEs divided by the total number of subjects.
The Common Terminology Criteria for Adverse Events (CTCAE v3.0) for Dermatology/Skin was used to determine the toxicity grade for a skin-related adverse event. (http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf)
Ratio to Baseline of Amylase
Ratio to baseline amylase at Day 5 was calculated as Day 5 amylase divided by baseline amylase.
Ratio to Baseline of Lipase.
Ratio to baseline lipase at Day 5 was calculated as Day 5 lipase divided by baseline lipase.
Ratio to Baseline of Protein/Creatinine
Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result.
Ratio to baseline protein/creatinine ratio was calculated as protein/creatinine ratio at specified day divided by baseline protein/creatinine ratio.
Secondary Outcome Measures
Palifermin Pharmacokinetic (PK) Parameters: Clearance (CL)
Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.
Descriptive PK parameters for palifermin CL for subjects assigned to Treatment A and Treatment B was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero.
Palifermin PK Parameters: CL
Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.
Descriptive PK parameters for palifermin CL for subjects assigned to Treatment A and Treatment B was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero.
Palifermin PK Parameters: Area Under the Serum Curve (AUC) (0-24)
Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.
Descriptive pharmacokinetic parameters for palifermin AUC(0-24) was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was deleted from calculation.
Palifermin PK Parameters: AUC (0-24)
Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.
Descriptive pharmacokinetic parameters for palifermin AUC(0-24) was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was deleted from calculation.
Palifermin PK Parameters: Estimated Concentration at Time 0 (C0)
Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.
Descriptive pharmacokinetic parameters for palifermin C0 was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero.
Palifermin PK Parameters: C0
Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.
Descriptive pharmacokinetic parameters for palifermin C0 was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero.
Palifermin PK Parameters: Apparent Volume of Distribution at Steady State (Vss)
Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin (Treatment A and Treatment B only).
Descriptive pharmacokinetic parameters for palifermin Vss was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero.
Palifermin PK Parameters: Vss
Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin (Treatment A and Treatment B only).
Descriptive pharmacokinetic parameters for palifermin Vss was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero.
Subject Incidence of Treatment-emergent Adverse Event
Adverse events (AE) was considered treatment emergent if the AE started after the time of heparin titration (Treatment A), palifermin dosing on Day 1 (Treatment B), or set zero point (Treatment C).
Subject Incidence of Proteinuria
Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result at the specified time point.
Incidence of proteinuria defined as urinary protein/creatinine ratio exceeding 200 mg/g was calculated at Day 4 and overall at any time point. Incidence was calculated by treatment as number of subjects with proteinuria divided by the total number of subjects.
Ratio to Baseline of Protein/Creatinine
Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result.
Ratio to baseline protein/creatinine ratio was calculated as protein/creatinine ratio at specified day divided by baseline protein/creatinine ratio.
Ratio to Baseline of Protein/Creatinine
Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result.
Ratio to baseline protein/creatinine ratio was calculated as protein/creatinine ratio at specified day divided by baseline protein/creatinine ratio.
Ratio to Baseline of Protein/Creatinine
Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result.
Ratio to baseline protein/creatinine ratio was calculated as protein/creatinine ratio at specified day divided by baseline protein/creatinine ratio.
Ratio to Baseline of Albumin/Creatinine
The albumin/creatinine ratio is the urinary albumin (mg) divided by the urinary creatinine (g) result at the specified time point.
Ratio to baseline was calculated as albumin/creatinine ratio at specified day divided by baseline albumin/creatinine ratio.
Ratio to Baseline of Albumin/Creatinine
The albumin/creatinine ratio is the urinary albumin (mg) divided by the urinary creatinine (g) result at the specified time point.
Ratio to baseline was calculated as albumin/creatinine ratio at specified day divided by baseline albumin/creatinine ratio.
Ratio to Baseline of Albumin/Creatinine
The albumin/creatinine ratio is the urinary albumin (mg) divided by the urinary creatinine (g) result at the specified time point.
Ratio to baseline was calculated as albumin/creatinine ratio at specified day divided by baseline albumin/creatinine ratio.
Ratio to Baseline of Albumin/Creatinine
The albumin/creatinine ratio is the urinary albumin (mg) divided by the urinary creatinine (g) result at the specified time point.
Ratio to baseline was calculated as albumin/creatinine ratio at specified day divided by baseline albumin/creatinine ratio.
Full Information
NCT ID
NCT01163097
First Posted
July 14, 2010
Last Updated
October 31, 2014
Sponsor
Swedish Orphan Biovitrum
1. Study Identification
Unique Protocol Identification Number
NCT01163097
Brief Title
Study to Characterize the Effect of Heparin on Palifermin Activity
Official Title
An Open-label, Randomized, Parallel-Design Study to Characterize the Effect of Heparin on Palifermin Activity in Healthy Adult Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swedish Orphan Biovitrum
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Palifermin 40 µg/kg and heparin IV infusion
Arm Type
Experimental
Arm Description
Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
Arm Title
Palifermin 40 µg/kg
Arm Type
Experimental
Arm Description
Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
Arm Title
Control group without any treatment
Arm Type
No Intervention
Arm Description
Treatment C: control group without any treatment administered.
Intervention Type
Drug
Intervention Name(s)
Palifermin
Intervention Description
40 µg/kg IV bolus injections for three consecutive days
Intervention Type
Drug
Intervention Name(s)
Heparin
Intervention Description
Heparin continuous IV infusion
Primary Outcome Measure Information:
Title
Ratio to Baseline of Epithelial Cell Proliferation as Assessed by Ki67 Staining of Buccal Mucosal Tissue.
Description
This outcome is a measure of the palifermin effect on the buccal mucosal cells. Ki67 is a measure of proliferation of cells in the buccal mucosa. This measure assess the number of cells per millimeter (mm) before and after palifermin treatment.
Time Frame
Day 4
Title
Incidence of Grade 2 or Higher Specific Skin-related Adverse Events.
Description
Incidence of grade 2 or higher specific skin-related treatment emergent adverse events following palifermin administration was calculated for subjects in treatment groups A and B. Incidence was calculated by treatment as number of subjects with grade 2 or higher specific skin-related AEs divided by the total number of subjects.
The Common Terminology Criteria for Adverse Events (CTCAE v3.0) for Dermatology/Skin was used to determine the toxicity grade for a skin-related adverse event. (http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf)
Time Frame
Day 45
Title
Ratio to Baseline of Amylase
Description
Ratio to baseline amylase at Day 5 was calculated as Day 5 amylase divided by baseline amylase.
Time Frame
Day 5
Title
Ratio to Baseline of Lipase.
Description
Ratio to baseline lipase at Day 5 was calculated as Day 5 lipase divided by baseline lipase.
Time Frame
Day 5
Title
Ratio to Baseline of Protein/Creatinine
Description
Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result.
Ratio to baseline protein/creatinine ratio was calculated as protein/creatinine ratio at specified day divided by baseline protein/creatinine ratio.
Time Frame
Day 4
Secondary Outcome Measure Information:
Title
Palifermin Pharmacokinetic (PK) Parameters: Clearance (CL)
Description
Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.
Descriptive PK parameters for palifermin CL for subjects assigned to Treatment A and Treatment B was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero.
Time Frame
Day 1
Title
Palifermin PK Parameters: CL
Description
Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.
Descriptive PK parameters for palifermin CL for subjects assigned to Treatment A and Treatment B was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero.
Time Frame
Day 3
Title
Palifermin PK Parameters: Area Under the Serum Curve (AUC) (0-24)
Description
Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.
Descriptive pharmacokinetic parameters for palifermin AUC(0-24) was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was deleted from calculation.
Time Frame
Day 1
Title
Palifermin PK Parameters: AUC (0-24)
Description
Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.
Descriptive pharmacokinetic parameters for palifermin AUC(0-24) was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was deleted from calculation.
Time Frame
Day 3
Title
Palifermin PK Parameters: Estimated Concentration at Time 0 (C0)
Description
Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.
Descriptive pharmacokinetic parameters for palifermin C0 was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero.
Time Frame
Day 1
Title
Palifermin PK Parameters: C0
Description
Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.
Descriptive pharmacokinetic parameters for palifermin C0 was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero.
Time Frame
Day 3
Title
Palifermin PK Parameters: Apparent Volume of Distribution at Steady State (Vss)
Description
Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin (Treatment A and Treatment B only).
Descriptive pharmacokinetic parameters for palifermin Vss was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero.
Time Frame
Day 1
Title
Palifermin PK Parameters: Vss
Description
Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin (Treatment A and Treatment B only).
Descriptive pharmacokinetic parameters for palifermin Vss was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero.
Time Frame
Day 3
Title
Subject Incidence of Treatment-emergent Adverse Event
Description
Adverse events (AE) was considered treatment emergent if the AE started after the time of heparin titration (Treatment A), palifermin dosing on Day 1 (Treatment B), or set zero point (Treatment C).
Time Frame
Day 45
Title
Subject Incidence of Proteinuria
Description
Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result at the specified time point.
Incidence of proteinuria defined as urinary protein/creatinine ratio exceeding 200 mg/g was calculated at Day 4 and overall at any time point. Incidence was calculated by treatment as number of subjects with proteinuria divided by the total number of subjects.
Time Frame
Day 4
Title
Ratio to Baseline of Protein/Creatinine
Description
Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result.
Ratio to baseline protein/creatinine ratio was calculated as protein/creatinine ratio at specified day divided by baseline protein/creatinine ratio.
Time Frame
Day 1
Title
Ratio to Baseline of Protein/Creatinine
Description
Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result.
Ratio to baseline protein/creatinine ratio was calculated as protein/creatinine ratio at specified day divided by baseline protein/creatinine ratio.
Time Frame
Day 2
Title
Ratio to Baseline of Protein/Creatinine
Description
Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result.
Ratio to baseline protein/creatinine ratio was calculated as protein/creatinine ratio at specified day divided by baseline protein/creatinine ratio.
Time Frame
Day 3
Title
Ratio to Baseline of Albumin/Creatinine
Description
The albumin/creatinine ratio is the urinary albumin (mg) divided by the urinary creatinine (g) result at the specified time point.
Ratio to baseline was calculated as albumin/creatinine ratio at specified day divided by baseline albumin/creatinine ratio.
Time Frame
Day 1
Title
Ratio to Baseline of Albumin/Creatinine
Description
The albumin/creatinine ratio is the urinary albumin (mg) divided by the urinary creatinine (g) result at the specified time point.
Ratio to baseline was calculated as albumin/creatinine ratio at specified day divided by baseline albumin/creatinine ratio.
Time Frame
Day 2
Title
Ratio to Baseline of Albumin/Creatinine
Description
The albumin/creatinine ratio is the urinary albumin (mg) divided by the urinary creatinine (g) result at the specified time point.
Ratio to baseline was calculated as albumin/creatinine ratio at specified day divided by baseline albumin/creatinine ratio.
Time Frame
Day 3
Title
Ratio to Baseline of Albumin/Creatinine
Description
The albumin/creatinine ratio is the urinary albumin (mg) divided by the urinary creatinine (g) result at the specified time point.
Ratio to baseline was calculated as albumin/creatinine ratio at specified day divided by baseline albumin/creatinine ratio.
Time Frame
Day 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maarten de Chateau, MD PhD
Organizational Affiliation
Swedish Orphan Biovitrum
Official's Role
Study Director
Facility Information:
Facility Name
New Orleans Center for Clinical Research (NOCCR)
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25880826
Citation
Yang BB, Gillespie B, Smith B, Smith W, Lissmats A, Rudebeck M, Kullenberg T, Olsson B. Pharmacokinetic and pharmacodynamic interactions between palifermin and heparin. J Clin Pharmacol. 2015 Oct;55(10):1109-18. doi: 10.1002/jcph.516. Epub 2015 May 28.
Results Reference
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Study to Characterize the Effect of Heparin on Palifermin Activity
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