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

Information source: Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Familial Mediterranean Fever

Intervention: colchicine sprinkle capsules (Drug); colchicine sprinkle capsules (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Mutual Pharmaceutical Company, Inc.

Official(s) and/or principal investigator(s):
Matthew Davis, MD, Study Chair, Affiliation: Mutual Pharmaceutical Company, Inc.

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.

Clinical Details

Official title: An Open-label, Parallel-group, Multiple-Dose, Pharmacokinetic and Safety Study of Colchicine Pediatric Formulation in Pediatric and Adult Patients With FMF

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

Maximum Plasma Concentration

Area Under the Concentration Time Curve from Time Zero to the Time of Last Measured Concentration (AUC 0-t)

Area Under the Concentration Time Curve from Zero through Infinity

Secondary outcome: Acute Phase Reactant (ESR, CRP, SAA) Levels

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.

Eligibility

Minimum age: 2 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Center of Medical Genetics and Primary Health Care, Yerevan 0010, Armenia

Soroka Medical Center, Beer Sheba 84141, Israel

Rambam Medical Center, Haifa 24035, Israel

Hadassah Medical Center, Jerusalem 91120, Israel

Pediatric Rheumatology Unit - Shaare Zedek Medical Center, Jerusalem 91031, Israel

Safra Children's Hospital, Tel Hashomer 52621, Israel

Sheba Medical Center, Tel Hashomer 52621, Israel

Hacettepe University, Ankara 06100, Turkey

Cerrahpasa Medical Facility, Istanbul 34303, Turkey

Childrens Hospital Los Angeles, Los Angeles, California 90027, United States

Additional Information

Starting date: August 2010
Last updated: January 9, 2012

Page last updated: August 20, 2015

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