Pharmacokinetics Study of Colchicine in Familial Mediterranean Fever (FMF) Patients
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| ClinicalTrials.gov Identifier: NCT01075906 |
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Recruitment Status :
Completed
First Posted : February 25, 2010
Last Update Posted : January 10, 2012
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Sponsor:
Mutual Pharmaceutical Company, Inc.
Information provided by (Responsible Party):
Mutual Pharmaceutical Company, Inc.
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Familial Mediterranean Fever | Drug: colchicine sprinkle capsules | Phase 1 |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 75 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Basic Science |
| 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 Start Date : | August 2010 |
| Actual Primary Completion Date : | December 2011 |
| Actual Study Completion Date : | December 2011 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Fever
Drug Information available for:
Colchicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Colchicine
Colchicine Sprinkle Capsules, 0.3 mg - dose administered according to age range on Day 1
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Drug: colchicine sprinkle capsules
0.3 mg |
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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
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Drug: colchicine sprinkle capsules
0.3 mg |
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- Acute Phase Reactant (ESR, CRP, SAA) Levels [ Time Frame: 15 days ]Pharmacodynamic samples collected pre-dose on Days 7, 1 and 15
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| Ages Eligible for Study: | 2 Years to 65 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01075906
Locations
| United States, California | |
| Childrens Hospital Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| Armenia | |
| Center of Medical Genetics and Primary Health Care | |
| Yerevan, Armenia, 0010 | |
| Israel | |
| Soroka Medical Center | |
| Beer Sheba, Israel, 84141 | |
| Rambam Medical Center | |
| Haifa, Israel, 24035 | |
| Pediatric Rheumatology Unit - Shaare Zedek Medical Center | |
| Jerusalem, Israel, 91031 | |
| Hadassah Medical Center | |
| Jerusalem, Israel, 91120 | |
| Safra Children's Hospital | |
| Tel Hashomer, Israel, 52621 | |
| Sheba Medical Center | |
| Tel Hashomer, Israel, 52621 | |
| Turkey | |
| Hacettepe University | |
| Ankara, Turkey, 06100 | |
| Cerrahpasa Medical Facility | |
| Istanbul, Turkey, 34303 | |
Sponsors and Collaborators
Mutual Pharmaceutical Company, Inc.
Investigators
| Study Chair: | Matthew Davis, MD | Mutual Pharmaceutical Company, Inc. |
| Responsible Party: | Mutual Pharmaceutical Company, Inc. |
| ClinicalTrials.gov Identifier: | NCT01075906 History of Changes |
| Other Study ID Numbers: |
MPC-006-09-1001 |
| First Posted: | February 25, 2010 Key Record Dates |
| Last Update Posted: | January 10, 2012 |
| Last Verified: | January 2012 |
Keywords provided by Mutual Pharmaceutical Company, Inc.:
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pharmacokinetics |
Additional relevant MeSH terms:
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Fever Brucellosis Familial Mediterranean Fever Hereditary Autoinflammatory Diseases Body Temperature Changes Signs and Symptoms Gram-Negative Bacterial Infections Bacterial Infections Genetic Diseases, Inborn Skin Diseases, Genetic |
Skin Diseases Colchicine Gout Suppressants Antirheumatic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |