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A Study of LY3154207 on Sleep in Healthy Male Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02603861
Recruitment Status : Completed
First Posted : November 13, 2015
Last Update Posted : April 6, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: LY3154207 Drug: Placebo Drug: Modafinil Phase 1

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Study Type : Interventional  (Clinical Trial)
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 : November 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Modafinil

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.




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

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02603861


Locations
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United States, California
Parexel Early Phase Unit at Glendale
Glendale, California, United States, 91206
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02603861    
Other Study ID Numbers: 15511
I7S-EW-HBEB ( Other Identifier: Eli Lilly and Company )
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action