A Study of LY3154207 on Sleep in Healthy Male Participants
An Evaluation of the Impact of Single Doses of LY3154207 on Sleep Latency in Sleep-Deprived Healthy Subjects
2 other identifiers
interventional
16
1 country
1
Brief Summary
This study will evaluate the effect of single doses of LY3154207 on the amount of time it takes for healthy sleep-deprived men to fall asleep. The study will also estimate how much LY3154207 gets into the blood stream and how long it takes the body to remove it. Information about any side effects that occur will be collected. Each participant will complete four study periods, which will last a total of about 8 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Nov 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 11, 2015
CompletedFirst Posted
Study publicly available on registry
November 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedApril 6, 2016
April 1, 2016
4 months
November 11, 2015
April 4, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Time to Sleep Onset
Day 1: 2 hours post dose through 8 hours post dose in each period.
Secondary Outcomes (2)
Maximum Concentration (Cmax) of LY3154207
Day 1: 1 hour post dose through 24 hours post dose in each period.
Area Under the Concentration Versus Time Curve (AUC) of LY3154207
Day 1: 1 hour post dose through 24 hours post dose in each period.
Study Arms (5)
Placebo
PLACEBO COMPARATORPlacebo matching LY3154207 administered once orally in one of four periods.
LY3154207 - Dose 1
EXPERIMENTALLY3154207 administered orally in no more than one of the four periods.
LY3154207 - Dose 2
EXPERIMENTALLY3154207 administered orally in no more than one of the four periods.
LY3154207 - Dose 3
EXPERIMENTALLY3154207 administered orally in no more than one of the four periods.
Modafinil
ACTIVE COMPARATOR200 mg modafinil administered orally in no more than one of the four periods.
Interventions
Eligibility Criteria
You may qualify if:
- Overtly healthy males 18 years of age or older who have given consent and are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
- Have a regular sleep pattern with routine time spent in bed between 6.5 hours and 9 hours each night
You may not qualify if:
- Are shift workers who shifted work within 14 days prior to screening or plan to during the study
- Have a known sleep disorder or history of a sleep disorder
- Have traveled 2 time zones or more within 7 days prior to screening or plan to during the study
- Regularly take naps during the day
- Are hearing impaired
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Parexel Early Phase Unit at Glendale
Glendale, California, 91206, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2015
First Posted
November 13, 2015
Study Start
November 1, 2015
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
April 6, 2016
Record last verified: 2016-04