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

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Brief Title

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

Official Title

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 Phase

Phase 1

Study Type

Interventional


Primary Outcome

Maximum Plasma Concentration

Secondary Outcome

 Acute Phase Reactant (ESR, CRP, SAA) Levels

Condition

Familial Mediterranean Fever

Intervention

colchicine sprinkle capsules

Study Arms / Comparison Groups

 Colchicine
Description:  Colchicine Sprinkle Capsules, 0.3 mg - dose administered according to age range on Day 1

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

75

Start Date

August 2010

Completion Date

December 2011

Primary Completion Date

December 2011

Eligibility Criteria

        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.
      

Gender

All

Ages

2 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Matthew Davis, MD, , 

Location Countries

Armenia

Location Countries

Armenia

Administrative Informations


NCT ID

NCT01075906

Organization ID

MPC-006-09-1001


Responsible Party

Sponsor

Study Sponsor

Mutual Pharmaceutical Company, Inc.


Study Sponsor

Matthew Davis, MD, Study Chair, Mutual Pharmaceutical Company, Inc.


Verification Date

January 2012