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

Completed · Phase 1

Conditions studied: Familial Mediterranean Fever

In brief

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.

Key facts

Study ID

NCT01075906

Run by

Mutual Pharmaceutical Company, Inc.

People needed

75

Starts

2010-08-01

Expected to finish

2011-12-01

Last updated by the study team

2012-01-10

Who can join

Age: 2 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Childrens Hospital Los Angeles — Los Angeles, California, United States
• Center of Medical Genetics and Primary Health Care — Yerevan, Yerevan, Armenia
• Soroka Medical Center — Beersheba, Beer Sheba, Israel
• Rambam Medical Center — Haifa, Haifa District, Israel
• Hadassah Medical Center — Jerusalem, Israel, Israel
• Pediatric Rheumatology Unit - Shaare Zedek Medical Center — Jerusalem, Jerusalem, Israel
• Safra Children's Hospital — Tel Litwinsky, Tel Hashomer, Israel
• Sheba Medical Center — Tel Litwinsky, Tel Hashomer, Israel
• Hacettepe University — Ankara, Ankara, Turkey (Türkiye)
• Cerrahpasa Medical Facility — Istanbul, Istanbul, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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