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NCT02677844 · ClinicalTrials.gov registry record · Phase 1
A Study of Abemaciclib in Healthy Participants
A Phase 1 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT02677844: Completed Phase 1 study, sponsored by Eli Lilly and Company.
NCT02677844 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02677844, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
The purposes of this study are to determine: * The effect of single increasing doses of the study drug, abemaciclib, on healthy participants. * The relationship between the amount of abemaciclib and the electrical tracing of the heart rhythm when abemaciclib is given. * How much abemaciclib is found in the bloodstream and how long the body takes to get rid of it. Information about any side effects that occur will be collected. The study will enroll two groups (cohorts) of participants. Each group will complete 4 study periods. This study is expected to last about 3 months. Screening may occur up to 28 days prior to enrollment. All participants will undergo a follow-up assessment approximately 21 days after administration of their final dose of study drug.
Primary Outcome
QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data. ECG monitoring was conducted using a 12-lead digital Holter recorder from approximately 2 hours predose through 24 hours postdose on Day 1 of each period using 12-lead digital Holter recorder. Fridericia-corrected QT interval (QTcF): QTcF = QT/RR1/3, where RR is the interval between two R waves.
Interventions
- DRUG Placebo
- DRUG Abemaciclib
- DRUG Loperamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2016-02 |
| Est. Completion | 2016-07 |
| Phase | Phase 1 |
What the finished NCT02677844 record still lists
NCT02677844 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02677844 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02677844 about?
NCT02677844 is a clinical study titled "A Study of Abemaciclib in Healthy Participants". The purposes of this study are to determine: * The effect of single increasing doses of the study drug, abemaciclib, on healthy participants. * The relationship between the amount of abemaciclib and the electrical tracing of the heart rhythm when abemaciclib is given. * How much abemaciclib is foun...
What is the current status of trial NCT02677844?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2016-02. Estimated completion is 2016-07.
What interventions are being tested in trial NCT02677844?
The interventions under investigation include: Placebo (DRUG), Abemaciclib (DRUG), Loperamide (DRUG).
Who is sponsoring clinical trial NCT02677844?
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 NCT02677844's enrollment target sits among peer trials
35 1258th of 2000 higher than 728 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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