A Study of LY3154207 on Sleep in Healthy Male Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Modafinil; Drug: LY3154207; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02603861

I7S-EW-HBEB (Other Identifier)

15511

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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16 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo matching LY3154207 administered once orally in one of four periods.

Treatment:

Drug: Placebo

LY3154207 - Dose 1

Experimental group

Description:

LY3154207 administered orally in no more than one of the four periods.

Treatment:

Drug: LY3154207

LY3154207 - Dose 2

Experimental group

Description:

LY3154207 administered orally in no more than one of the four periods.

Treatment:

Drug: LY3154207

LY3154207 - Dose 3

Experimental group

Description:

LY3154207 administered orally in no more than one of the four periods.

Treatment:

Drug: LY3154207

Modafinil

Active Comparator group

Description:

200 mg modafinil administered orally in no more than one of the four periods.

Treatment:

Drug: Modafinil