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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 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 30 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01836198
The ClinicalTrials.gov registry entry for NCT01836198 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Clarithromycin is the first listed.
NCT01836198 reports 0 study locations.
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.
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