A Study of LY3154207 on Sleep in Healthy Male Participants
- Registration Number
- NCT02603861
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 16
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo matching LY3154207 administered once orally in one of four periods. LY3154207 - Dose 1 LY3154207 LY3154207 administered orally in no more than one of the four periods. LY3154207 - Dose 2 LY3154207 LY3154207 administered orally in no more than one of the four periods. LY3154207 - Dose 3 LY3154207 LY3154207 administered orally in no more than one of the four periods. Modafinil Modafinil 200 mg modafinil administered orally in no more than one of the four periods.
- Primary Outcome Measures
Name Time Method Time to Sleep Onset Day 1: 2 hours post dose through 8 hours post dose in each period.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Parexel Early Phase Unit at Glendale
🇺🇸Glendale, California, United States
Parexel Early Phase Unit at Glendale🇺🇸Glendale, California, United States