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Pharmacokinetics Study of Colchicine in Familial Mediterranean Fever (FMF) Patients

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ClinicalTrials.gov Identifier: NCT01075906
Recruitment Status : Completed
First Posted : February 25, 2010
Last Update Posted : January 10, 2012
Sponsor:
Information provided by (Responsible Party):
Mutual Pharmaceutical Company, Inc.

Tracking Information
First Submitted Date  ICMJE February 24, 2010
First Posted Date  ICMJE February 25, 2010
Last Update Posted Date January 10, 2012
Study Start Date  ICMJE August 2010
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2010)
  • Maximum Plasma Concentration [ Time Frame: 15 days ]
    pharmacokinetic samples collected pre-dose on Days 1, 2 and 15 and at 0.25 - 0.5 hours, 1.5-2.5 hours and at 5-8 hours post-dose on Days 1 and 15
  • Area Under the Concentration Time Curve from Time Zero to the Time of Last Measured Concentration (AUC 0-t) [ Time Frame: 15 days ]
    Pharmacokinetic samples collected pre-dose on Days 1,2 and 15 and at 0.25-0.5 hours, 1.5-2.5 hours and 5-8 hours post-dose on Days 1 and 15.
  • Area Under the Concentration Time Curve from Zero through Infinity [ Time Frame: 15 days ]
    Pharmacokinetic samples collected pre-dose on Days 1, 2 and 15 and at 0.25-0.5 hours, 1.5-2.5 hours and at 5-8 hours post-dose on Days 1 and 15
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2010)
Acute Phase Reactant (ESR, CRP, SAA) Levels [ Time Frame: 15 days ]
Pharmacodynamic samples collected pre-dose on Days 7, 1 and 15
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics Study of Colchicine in Familial Mediterranean Fever (FMF) Patients
Official Title  ICMJE An Open-label, Parallel-group, Multiple-Dose, Pharmacokinetic and Safety Study of Colchicine Pediatric Formulation in Pediatric and Adult Patients With FMF
Brief Summary

Colchicine is widely recognized as safe and effective treatment of Familial Mediterranean Fever (FMF) in children and adults. Colchicine is currently used to treat FMF in younger patients by inexact dosing through breaking or crushing adult-dose tablets. An age-appropriate sprinkle formulation will allow for more accurate dosing in pediatric patients. The primary objective of this study is to evaluate and compare the steady-state pharmacokinetics of multiple oral doses of colchicine sprinkle capsules administered to pediatric and adult FMF patients.

Secondary objectives include evaluation of the safety and tolerability of this regimen in pediatric and adult FMF patients and measurement of the levels of acute phase reactants (i.e, serum amyloid A [SAA], erythrocyte sedimentation rate [ESR], C-reactive protein [CRP]) at baseline and after dosing.

Detailed Description FMF patients who have not been taking colchicine (colchicine-naïve patients) will be enrolled into a 1 week dose-titration period (Days -7 to -1). Beginning on Day -7, a pre-dose blood sample will be collected from the colchicine-naïve patient population for determination of pharmacodynamic markers. Patients will then be administered a low starting dose of colchicine (as determined by the principal investigator) titrated up to the study colchicine dose which is 0.6 mg (2 capsules) in children ≥2 to < 6 years old, 0.9 mg (3 capsules) in children ≥6 to < 12, 1.2 mg (4 capsules) in children ≥12 to < 16 and adults ≥16 and < 65. On Day 2, patients will return to the clinic for collection of a pre-dose blood sample followed by administration of the study dose of colchicine. On Days 3-7, patients (parent/guardian) will self-medicate with the study dose of colchicine recording the time of dosing and any adverse events. On Days 8-14, patients (parent/guardian) will self-medicate with the study dose of colchicine recording the time of dosing and any adverse events. On the morning of Day 15, patients will return to the clinic for collection of a pre-dose blood sample followed by administration of the study dose of colchicine. Blood samples will be collected post-dose at times sufficient to adequately define the pharmacokinetics of colchicine and its metabolites. Safety and tolerability of this dosing regimen will be determined by evaluation of vital signs and adverse events during the study and upon completion of the study. All adverse events will be evaluated by the investigator and reported in the subject's case report form.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Familial Mediterranean Fever
Intervention  ICMJE Drug: colchicine sprinkle capsules
0.3 mg
Study Arms  ICMJE
  • Experimental: Colchicine
    Colchicine Sprinkle Capsules, 0.3 mg - dose administered according to age range on Day 1
    Intervention: Drug: colchicine sprinkle capsules
  • Experimental: colchicine at steady state
    colchicine sprinkle capsules 0.3 mg - dose administered according to age range on Day 15 following once daily dosing of colchicine on Days 2 - 14
    Intervention: Drug: colchicine sprinkle capsules
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 24, 2010)
75
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients age 2-65 years with a confirmed clinical diagnosis of FMF,
  • Non-pregnant, and
  • If of child-bearing potential, using effective contraceptive measures.

Exclusion Criteria:

  • Recent participation (within 30 days) in other research studies,
  • Pregnant or lactating,
  • History or current infection of human immunodeficiency virus (HIV), hepatitis A, B or C,
  • Current or recent use of any drugs/drug classes or combinations thereof that may affect the absorption or metabolism of colchicine,
  • Clinically relevant abnormal clinical laboratories at screening,
  • Current or recent (<6 months) history of severe, unstable or uncontrolled neurological, cardiovascular, gastrointestinal, hematological, moderate or severe hepatic and/or renal disease, or evidence of other diseases at the physical examination conducted at the screening.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Armenia,   Israel,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01075906
Other Study ID Numbers  ICMJE MPC-006-09-1001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mutual Pharmaceutical Company, Inc.
Study Sponsor  ICMJE Mutual Pharmaceutical Company, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Matthew Davis, MD Mutual Pharmaceutical Company, Inc.
PRS Account Mutual Pharmaceutical Company, Inc.
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP