Healthy VolunteersPhase 1NCT00361348
Palifermin DDI (Drug Drug Interaction)
A Phase 1 study testing Palifermin and Heparin in people with Healthy Volunteers, run by Swedish Orphan Biovitrum.
Trial summary
The purpose of this study is to determine if Paliferim interacts with Heparin. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Palifermin and Heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Dec 2005to Jul 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
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).
About this study
Official title: 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
The purpose of this study is to determine if Paliferim interacts with Heparin.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- Palifermin, Heparin
- Keywords
- Palifermin, drug interaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaliferminDrug
Also called Kepivance
HeparinDrug
| Study group | Role | What they receive |
|---|---|---|
| Palifermin | Active comparator | A single 60µg/kg IV bolus dose of palifermin on Day 1 of the treatment period Receives: Drug: Palifermin |
| Palifermin + Heparin | Experimental | 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 Receives: Drug: Palifermin; Drug: Heparin |
| Heparin | Active comparator | unfractionated heparin for a 2 to 3 day heparin titation/maintenance period and continuing through a 3 day treatment period Receives: Drug: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (2)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2006 (estimated)
- Study startDec 2005
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Swedish Orphan BiovitrumThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- Swedish Orphan Biovitrum
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Biovitrum AB (publ)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00361348
- Sponsor's protocol ID
- 20050137
- Status last verified
- Nov 2014
- First submitted
- 4 Aug 2006
- Last updated
- 6 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25880826
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00361348
- Acronym / sponsor ID
- 20050137
- Conditions
- Healthy Volunteers
- Keywords
- Palifermin, drug interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- Swedish Orphan BiovitrumIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 8 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Palifermin | Active comparator | Drug: PaliferminA single 60µg/kg IV bolus dose of palifermin on Day 1 of the treatment period |
| Palifermin + Heparin | Experimental | Drug: Palifermin, Drug: HeparinA 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 |
| Heparin | Active comparator | Drug: Heparinunfractionated heparin for a 2 to 3 day heparin titation/maintenance period and continuing through a 3 day treatment period |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PaliferminAlso: Kepivance | Drug | Palifermin, Palifermin + Heparin |
| Heparin | Drug | Heparin, Palifermin + Heparin |
Primary outcome
To evaluate the effect of a continuous intravenous (IV) infusion of unfractionated heparin on the single-dose pharmacokinetics (PK) of palifermin in healthy subjects.
2 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2014.
- Derived from this study: PubMed 25880826Yang 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.
- FDA-approved Drug LabelingLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Biovitrum AB (publ)
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Palifermin and Heparin in people with Healthy Volunteers, run by Swedish Orphan Biovitrum.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effect of a continuous intravenous (IV) infusion of unfractionated heparin on the single-dose pharmacokinetics (PK) of palifermin in healthy subjects.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00361348, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2014.