Phase 4 Completed N=30 Basic Science

Drug Interaction Study of Colchicine and Theophylline

Healthy

Source: ClinicalTrials.gov NCT01601132 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2013

Primary outcomePrimary: Time to Reach the Maximum Plasma Concentration (Tmax) of Theophylline — 1.25; 1.5 hours — p=0.5663

Summary

Colchicine is a supressor of hepatic CYP1A2 and theophylline is a sensitive CYP1A2 probe substrate. When the two are co-administered the potential exists for a clinically significant drug interaction. This study aims to determine the effect of steady-state colchicine on the pharmacokinetics of theophylline administered as a single dose. A secondary goal is to evaluate the safety and tolerability of this regimen in healthy volunteers. All study subjects will be monitored for adverse events throughout the entire study period.

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to Reach the Maximum Plasma Concentration (Tmax) of Theophylline	1.25; 1.5	0.5663
PRIMARY Maximum Plasma Concentration (Cmax) of Theophylline	11.0; 11.7	—
PRIMARY Area Under the Concentration Versus Time Curve From Time 0 to Time of the Last Quantifiable Concentration[AUC(0-t)]	155.6; 164.0	—
PRIMARY Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]	180.7; 185.7	—
PRIMARY Apparent Total Body Clearance (CL/F) of Theophylline	1.832; 1.741	—
PRIMARY Apparent Total Volume of Distribution (Vd/F) of Theophylline	36.21; 34.44	—

Eligibility Criteria

Inclusion Criteria

Healthy adults 18-45 years of age, non smoking and non-pregnant (postmenopausal, surgically sterile or using effective contraceptive measures) with a body mass index (BMI) greater than or equal to 18 and less than or equal to 32, inclusive; hemoglobin greater than or equal to 11.5g/dL

Exclusion Criteria

Recent participation (within 28 days) in other research studies
Recent significant blood donation or donation of plasma
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
Subjects who test positive for drugs of abuse or alcohol at screening or check-in
History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease or active sexually transmitted disease
History of neuropathy or muscle disorders, peptic ulcer disease, clinically significant cardiac arrhythmias, seizure disorder, and low white blood cell count or other bone marrow disorders
Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose and throughout the study
History of allergy or sensitivity to colchicine or theophylline or aminophylline
Subjects who have had a tattoo or body piercing within 30 days prior to administration of study drug
Subjects with irritable bowel syndrome, chronic diarrhea or other chronic gastro-intestinal problems
Subjects who are lactose intolerant

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01601132). 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. Informational only — not medical advice.