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NCT02659865 · ClinicalTrials.gov registry record · Phase 1
A Study of LY3039478 in Healthy Participants
A Phase 1 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT02659865: Completed Phase 1 study, sponsored by Eli Lilly and Company.
NCT02659865 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02659865, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study Summary
The main purpose of this study is to investigate the safety of the study drug known as LY3039478 and evaluate two different formulations of LY3039478 in healthy participants. Part A has three periods. Either LY3039478 or placebo will be given once by mouth in each period. Part B has two periods. Participants will receive both formulations of LY3039478, by mouth, over the course of the study. Both parts of the study will also explore how much LY3039478 gets into the bloodstream and how long it takes the body to get rid of it. Information about any side effects will also be collected. Participants may only enroll in one part. The study will last at least 33 days, not including screening. Screening must be performed up to 30 days before enrollment. Part B was added by protocol amendment approved in April, 2016.
Primary Outcome
PK: mean time-matched difference in QTcF interval with time-matched concentrations between LY3039478 capsule formulation (formulation 3) compared to placebo. Analyses of QTcF was assessed by the mean change in QTcF as a function of plasma drug concentration. Triplicate measures at each time point was averaged prior to analysis. The primary analysis was based on the time-matched placebo-adjusted QTcF (ΔQTcF) for each time point, which was calculated by subtracting each participant's time-matched
Interventions
- DRUG Placebo
- DRUG LY3039478 Capsule Formulation (Formulation 3)
- DRUG LY3039478 Drug-in Capsule (Reference, Formulation 1)
- DRUG LY3039478 Formulated Capsule (Test, Formulation 3)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2016-01 |
| Est. Completion | 2016-06 |
| Phase | Phase 1 |
What the finished NCT02659865 record still lists
NCT02659865 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02659865 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02659865 about?
NCT02659865 is a clinical study titled "A Study of LY3039478 in Healthy Participants". The main purpose of this study is to investigate the safety of the study drug known as LY3039478 and evaluate two different formulations of LY3039478 in healthy participants. Part A has three periods. Either LY3039478 or placebo will be given once by mouth in each period. Part B has two periods. Par...
What is the current status of trial NCT02659865?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2016-01. Estimated completion is 2016-06.
What interventions are being tested in trial NCT02659865?
The interventions under investigation include: Placebo (DRUG), LY3039478 Capsule Formulation (Formulation 3) (DRUG), LY3039478 Drug-in Capsule (Reference, Formulation 1) (DRUG), LY3039478 Formulated Capsule (Test, Formulation 3) (DRUG).
Who is sponsoring clinical trial NCT02659865?
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 NCT02659865's enrollment target sits among peer trials
29 1440th of 2000 higher than 554 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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