Clincosm LogoSign in Get a demo

A Study of LY3154207 on Sleep in Healthy Male Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT02603861
Collaborator
(none)
16
Enrollment
1
Location
5
Arms
4
Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
An Evaluation of the Impact of Single Doses of LY3154207 on Sleep Latency in Sleep-Deprived Healthy Subjects
Study Start Date :
Nov 1, 2015
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

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

Drug: Placebo
Placebo administered orally.
Experimental: LY3154207 - Dose 1

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

Drug: LY3154207
LY3154207 administered orally.
Experimental: LY3154207 - Dose 2

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

Drug: LY3154207
LY3154207 administered orally.
Experimental: LY3154207 - Dose 3

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

Drug: LY3154207
LY3154207 administered orally.
Active Comparator: Modafinil

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

Drug: Modafinil
Modafinil administered orally.

Outcome Measures

Primary Outcome Measures

  1. Time to Sleep Onset [Day 1: 2 hours post dose through 8 hours post dose in each period.]

Secondary Outcome Measures

  1. Maximum Concentration (Cmax) of LY3154207 [Day 1: 1 hour post dose through 24 hours post dose in each period.]

  2. Area Under the Concentration Versus Time Curve (AUC) of LY3154207 [Day 1: 1 hour post dose through 24 hours post dose in each period.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Parexel Early Phase Unit at Glendale Glendale California United States 91206

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02603861
Other Study ID Numbers:
  • 15511
  • I7S-EW-HBEB
First Posted:
Nov 13, 2015
Last Update Posted:
Apr 6, 2016
Last Verified:
Apr 1, 2016
Additional relevant MeSH terms:
Modafinil

Study Results

No Results Posted as of Apr 6, 2016