Drug Interaction Study of Colchicine and Theophylline
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.
Timeline
- Start
- 2012-05
- Primary completion
- 2012-07
- Completion
- 2012-07
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Theophylline vs Theophylline + Colchicine; p = 0.5663; Wilcoxon (Mann-Whitney); note: Significant difference defined a priori as p \< 0.05 NCT01601132 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Colchicine | Small molecule | 0.6 mg | Oral |
| Subject | Theophylline | Small molecule | 300 mg | — |
Indications
No indication recorded.