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NCT01836198 · ClinicalTrials.gov registry record · Phase 1
The Effect of Gemfibrozil, Ketoconazole and Clarithromycin on the Amount of LY2409021 in the Bloodstream
A Phase 1 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT01836198: Completed Phase 1 study, sponsored by Eli Lilly and Company.
NCT01836198 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01836198, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
The purpose of this study is to examine the effect of gemfibrozil, ketoconazole, and clarithromycin on how much LY2409021 is found in the bloodstream and how long the body takes to get rid of it. The study is split into two parts, Part A and Part B. Participants in Part A are divided into two cohorts (groups). Each cohort will participate in two study periods. Period 1 involves a single dose of LY2409021. Period 2 involves either gemfibrozil or ketoconazole given daily for 21 days with LY2409021 given once on Day 4. Part A will last for 51 days and will also involve screening within 27 days of the start of the study. Part B is only open to participants who successfully completed Part A of the study. Participants in Part B will receive clarithromycin given daily for 21 days with LY2409021 given once on Day 4. Part B will last for 29 days and will also involve screening within 27 days of the start of the study.
Interventions
- DRUG Clarithromycin
- DRUG Ketoconazole
- DRUG LY2409021
- DRUG Gemfibrozil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2013-05 |
| Est. Completion | 2013-11 |
| Phase | Phase 1 |
What the finished NCT01836198 record still lists
NCT01836198 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 4 interventions - of which Clarithromycin is the first listed.
NCT01836198 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01836198 about?
NCT01836198 is a clinical study titled "The Effect of Gemfibrozil, Ketoconazole and Clarithromycin on the Amount of LY2409021 in the Bloodstream". The purpose of this study is to examine the effect of gemfibrozil, ketoconazole, and clarithromycin on how much LY2409021 is found in the bloodstream and how long the body takes to get rid of it. The study is split into two parts, Part A and Part B. Participants in Part A are divided into two cohort...
What is the current status of trial NCT01836198?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2013-05. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01836198?
The interventions under investigation include: Clarithromycin (DRUG), Ketoconazole (DRUG), LY2409021 (DRUG), Gemfibrozil (DRUG).
Who is sponsoring clinical trial NCT01836198?
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 NCT01836198's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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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