Phase 1 N=18 Randomized Quadruple-blind Basic Science

Pharmacokinetic and Exploratory Electrocardiogram (ECG) Study

Pharmacokinetics

Bottom Line

View on ClinicalTrials.gov: NCT01018420 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2009

Primary outcome: Primary: Maximum Plasma Concentration (Cmax) — 6.84 ng/mL

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Colchicine (Drug); Moxifloxacin (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Mutual Pharmaceutical Company, Inc.
Primary completion: Dec 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Plasma Concentration (Cmax)	6.84	—
PRIMARY Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]	104.95	—
PRIMARY Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]	118.20	—
SECONDARY Electrocardiogram (ECG) Evaluation of the QTcF Interval (Colchicine)	401.62; 397.80; 401.76; 394.73; 388.84; 393.93	—
SECONDARY Electrocardiogram (ECG) Evaluation of the QTcF Interval (Moxifloxacin)	402.11; 398.89; 403.67; 397.00; 397.89; 397.44	—

Summary

This study will characterize the pharmacokinetics of colchicine after an oral dosing regimen of 4.8 mg over 6 hours. In addition it will compare the electrocardiogram (ECG) changes, if any, from this dosing regimen to that of a single dose of moxifloxacin 400 mg, a positive control for the corrected QT interval (QTc) prolongation.

Eligibility Criteria

Inclusion Criteria

Healthy adults 18-55 years of age, non smoking and non-pregnant, weighing at least 55kg and within 15% of ideal body weight, with no significant EKG changes

Exclusion Criteria

Pregnant or lactating
Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
Recent (2-year) history or evidence of alcoholism or drug abuse
History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease
History or family history of congenital long QT syndrome (LQTS) or sudden death possibly related to LQTS
Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 30 days prior to the first dose and throughout the study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01018420). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.