- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01329991
Phase 1b Study of PLX5622 in Rheumatoid Arthritis Patients Who Are Receiving Methotrexate
April 10, 2012 updated by: Plexxikon
A Phase 1b Study to Assess Safety, Pharmacokinetics, Pharmacodynamics, and Drug-Drug Interaction of PLX5622 in Patients With Rheumatoid Arthritis Who Are Receiving Methotrexate
PLX115-02 is a phase 1b study to assess how the study drug, PLX5622: 1. affects the body, 2. how the body affects PLX5622 3. the interaction of PLX5622 with Methotrexate and 4. the safety of PLX5622 in rheumatoid arthritis patients taking Methotrexate
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Anniston, Alabama, United States, 36207
- Pinnacle Research Group
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Michigan
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Lansing, Michigan, United States, 48910
- Medical Practice of Justus Fiechtner, MD
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Pennsylvania
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Duncansville, Pennsylvania, United States, 16635
- Altoona Center for Clinical Research
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Texas
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Dallas, Texas, United States, 75231
- Metroplex Clinical Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female patients ≥ 18 years old with a diagnosis of rheumatoid arthritis by ACR criteria for ≥ 3 months.
- Prior to Day 1, patients must be on oral or subcutaneous methotrexate (≥10 mg/week and ≤ 25 mg/week) for at least 12 weeks (with a stable dose for at least 4 weeks) and folate (≥ 5 mg/week) for at least 6 weeks, and willing to continue on this regimen for the duration of the study.
- Adequate hematologic, hepatic, and renal function (absolute neutrophil count ≥ 1.5 X 109/L, Hgb > 9 g/dL, platelet count ≥ 100 X 109/L, AST/ALT WNL, albumin ≥ 3 g/dL, calculated CrCl>60 mL/min using Cockcroft-Gault formula).
- Women of child-bearing potential must have a negative pregnancy test within 7 days prior to initiation of dosing with study drug and must agree to use a double barrier method of birth control from the time of the negative pregnancy test up to 30 days after the last dose of study drug. Women of nonchildbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥ 1 year.
- Fertile men must agree to use an acceptable method of birth control while on study drug. Acceptable methods of contraception must include either abstinence from the first dose of study drug through 4 weeks after the last dose of study drug, or use of a condom with instructions to the female partner of child-bearing potential to also be protected as above.
- Willing and able to provide written informed consent prior to any study-related procedures and to comply with all study requirements.
Exclusion Criteria:
- Use of biologic response modifiers within the following periods prior to Day 1: 4 weeks for Kineret (anakinra) and Enbrel (etanercept); 12 weeks for Remicade (infliximab), Humira (adalimumab), Simponi (golimumab), Orencia (abatacept), Actemra (tocilizumab), or Cimzia (certolizumab); 12 months for Rituxan (rituximab).
- Use of Arava (leflunomide) within 12 weeks prior to Day 1 or any immunosuppressive agents, including hydroxychloroquine or sulfasalazine, within 4 weeks of Day 1.
- Investigational drug use within 4 weeks of Day 1.
- Positive urine drug screen for drugs of abuse (except for opiates if being used for RA).
- Concomitant use of DMARDs (other than methotrexate), biological response modifiers, or known strong inducers or inhibitors of CYP3A4 (see Appendix 2).
- Uncontrolled intercurrent illness.
- Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption.
- QTc ≥ 450 msec at Screening.
- The presence of a medical or psychiatric condition that, in the opinion of the Principal Investigator, makes the patient inappropriate for inclusion in this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: oral dose of 200 mg PLX5622
6 subjects will be randomized to take an oral dose of PLX5622 for 14 days and 2 subjects will be randomized to take placebo.
|
PLX5622 drug substance is an achiral,small molecule Fms kinase inhibitor.
The drug product is available in capsule form, to be taken orally, in a dosage strength of 100 mg with matching placebo
|
Active Comparator: oral dose of 400 mg PLX5622
6 subjects will be randomized to take an oral dose of PLX5622 for 14 days and 2 subjects will be randomized to take placebo.
|
PLX5622 drug substance is an achiral,small molecule Fms kinase inhibitor.
The drug product is available in capsule form, to be taken orally, in a dosage strength of 100 mg with matching placebo
|
Active Comparator: oral dose of 800 mg PLX5622
6 subjects will be randomized to take an oral dose of PLX5622 for 14 days and 2 subjects will be randomized to take placebo.
|
PLX5622 drug substance is an achiral,small molecule Fms kinase inhibitor.
The drug product is available in capsule form, to be taken orally, in a dosage strength of 100 mg with matching placebo
|
Active Comparator: oral dose of PLX5622-dose to be determined
6 subjects will be randomized to take an oral dose of PLX5622 for 14 days and 2 subjects will be randomized to take placebo.
|
PLX5622 drug substance is an achiral,small molecule Fms kinase inhibitor.
The drug product is available in capsule form, to be taken orally, in a dosage strength of 100 mg with matching placebo
|
Placebo Comparator: Placebo Comparator
2 patients per cohort will be randomly assigned to take placebo.
8 patients total will be randomized to take placebo in this study.
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Matching placebo for PLX5622
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety-Number of patients with adverse events
Time Frame: 22 days
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Subjects will take oral doses of PLX5622 once a day for 14 days.
Physical examinations, vital signs, 12-lead electrocardiograms (ECG), adverse events, hematology, serum chemistry, coagulation, and urinalysis will be used to assess safety throughout Day 1-14 of the study, Day 17 and the follow up study visit on day 22.
Adverse events will be monitored and reviewed for safety issues/abnormal changes in the above mentioned tests.
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22 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetic profile: Measurement of area under the plasma-concentration-time curve
Time Frame: 22 days
|
The pharmacokinetic profile of plasma PLX5622 and Methotrexate will be analyzed by measurement of area under the plasma concentration-time curve [AUC0-t, AUC0-inf, AUC0-24].
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22 days
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Pharmacokinetic evaluation: Measurement of Peak Concentration
Time Frame: 22 days
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The pharmacokinetic profile of plasma PLX5622 and Methotrexate will be analyzed by measurement of peak concentration (Cmax) and time to peak concentration (Tmax).
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22 days
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Pharmacokinetic profile: Measurement of half life, apparent systemic clearance, and apparent volume of distribution, terminal phase.
Time Frame: 22 days
|
The pharmacokinetic profile of plasma PLX5622 and Methotrexate will be analyzed by measurement of half-life (T1/2), apparent systemic clearance (CL/F), and apparent volume of distribution, terminal phase (Vz/F).
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22 days
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Pharmacodynamics-Effect of PLX5622 on the body
Time Frame: 22 days
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The effects of PLX5622 on the body will be measured by observing early response biomarkes of disease activity.
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22 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
April 4, 2011
First Submitted That Met QC Criteria
April 5, 2011
First Posted (Estimate)
April 6, 2011
Study Record Updates
Last Update Posted (Estimate)
April 12, 2012
Last Update Submitted That Met QC Criteria
April 10, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PLX115-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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