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NCT01263106 · ClinicalTrials.gov registry record · Phase 1
A Study of LY2216684 and Theophylline in Healthy Subjects
A Phase 1 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT01263106: Completed Phase 1 study, sponsored by Eli Lilly and Company.
NCT01263106 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01263106, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
The primary objective of this study is to confirm that LY2216684 is not an inhibitor of cytochrome P450 1A2 (CYP1A2) in healthy participants using theophylline as a probe substrate for the enzyme. Because LY2216684 has been observed to increase heart rate in some healthy participants, this study will also assess heart rate when coadministered with theophylline.
Primary Outcome
The Least Squares (LS) geometric mean was based on AUC0-∞. The AUC for theophylline was calculated on Day 1 of a given period when theophylline was administered alone and on Day 3 of another period when theophylline was coadministered with LY2216684.
Interventions
- DRUG Theophylline
- DRUG LY2216684
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2010-12 |
| Est. Completion | 2011-01 |
| Phase | Phase 1 |
What the finished NCT01263106 record still lists
NCT01263106 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Theophylline is the first listed.
NCT01263106 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01263106 about?
NCT01263106 is a clinical study titled "A Study of LY2216684 and Theophylline in Healthy Subjects". The primary objective of this study is to confirm that LY2216684 is not an inhibitor of cytochrome P450 1A2 (CYP1A2) in healthy participants using theophylline as a probe substrate for the enzyme. Because LY2216684 has been observed to increase heart rate in some healthy participants, this study wil...
What is the current status of trial NCT01263106?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2010-12. Estimated completion is 2011-01.
What interventions are being tested in trial NCT01263106?
The interventions under investigation include: Theophylline (DRUG), LY2216684 (DRUG).
Who is sponsoring clinical trial NCT01263106?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01263106's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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