Pharmacokinetics Study of Colchicine in Familial Mediterranean Fever (FMF) Patients
Mo kle
Abstrè
Deskripsyon
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.
Dat
| Dènye verifye: | 12/31/2011 |
| Premye Soumèt: | 02/23/2010 |
| Enskripsyon Estimasyon Soumèt: | 02/23/2010 |
| Premye afiche: | 02/24/2010 |
| Dènye Mizajou Soumèt: | 01/08/2012 |
| Dènye Mizajou afiche: | 01/09/2012 |
| Dat aktyèl kòmanse etid la: | 07/31/2010 |
| Dat Estimasyon Prensipal Estimasyon an: | 11/30/2011 |
| Dat estime fini etid la: | 11/30/2011 |
Kondisyon oswa maladi
Entèvansyon / tretman
Drug: Colchicine
Drug: colchicine at steady state
Faz
Gwoup bra
| Bra | Entèvansyon / tretman |
|---|---|
| Experimental: Colchicine Colchicine Sprinkle Capsules, 0.3 mg - dose administered according to age range on Day 1 | Drug: Colchicine 0.3 mg |
| 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 | Drug: colchicine at steady state 0.3 mg |
Kritè kalifikasyon yo
| Laj ki kalifye pou etid | 2 Years Pou 2 Years |
| Sèks ki kalifye pou etid | All |
| Aksepte Volontè Healthy | Wi |
| Kritè | 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. |
Rezilta
Mezi Rezilta Prensipal yo
1. Maximum Plasma Concentration [15 days]
2. Area Under the Concentration Time Curve from Time Zero to the Time of Last Measured Concentration (AUC 0-t) [15 days]
3. Area Under the Concentration Time Curve from Zero through Infinity [15 days]
Mezi Rezilta Segondè
1. Acute Phase Reactant (ESR, CRP, SAA) Levels [15 days]
