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NCT01601132 · ClinicalTrials.gov registry record · Phase 4
Drug Interaction Study of Colchicine and Theophylline
A Phase 4 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
NCT01601132: Completed Phase 4 study, sponsored by Takeda.
NCT01601132 is a Phase 4 study that has completed, run by Takeda. The registered enrollment target is 30 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01601132, a Phase 4 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
Study 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.
Primary Outcome
The time to each the maximum or peak concentration of theophylline in the plasma, after a single dose on Day 1, and after a single dose on Day 19, following 14 days of colchicine dosing.
Interventions
- DRUG theophylline
- DRUG colchicine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2012-05 |
| Est. Completion | 2012-07 |
| Phase | Phase 4 |
What the finished NCT01601132 record still lists
NCT01601132 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which theophylline is the first listed.
NCT01601132 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01601132 about?
NCT01601132 is a clinical study titled "Drug Interaction Study of Colchicine and Theophylline". 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 theop...
What is the current status of trial NCT01601132?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2012-05. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01601132?
The interventions under investigation include: theophylline (DRUG), colchicine (DRUG).
Who is sponsoring clinical trial NCT01601132?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01601132's enrollment target sits among peer trials
30 1552nd of 2000 higher than 367 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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