A Study of LY2624803 in Japanese Participants With Transient Insomnia (NCT01784614) | Clinical Trial Compass
CompletedPhase 1
A Study of LY2624803 in Japanese Participants With Transient Insomnia
Japan24 participantsStarted 2009-09
Plain-language summary
The aim of this study is to learn how different doses of LY2624803 affect sleep in healthy Japanese participants. The study has four treatment periods. Participants will receive a single dose of LY2624803 or placebo in each treatment period.
Who can participate
Age range20 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Overtly healthy males or female Japanese
* Women of child-bearing potential, who test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a reliable method of birth control during the study and for 3 months following the last dose of study drug
* Body mass index (BMI) of 17.6 to 26.4 kilogram per meter square (kg/m\^2), inclusive
* Normal bedtime hours, with routine time spent in bed between 6.5 hours and 9 hours each night
* Clinical laboratory test results within normal reference range
* Venous access sufficient to allow blood sampling as per the protocol
* Are reliable and willing to make themselves available for the duration of the study and are willing and able to follow study procedures
* Have given written informed consent approved by Lilly and the ethical review board governing the site
Exclusion Criteria:
* Within 4 months of the initial dose of study drug, have received treatment with a drug that has not received regulatory approval for any indication
* Persons who have previously completed or withdrawn from this study or any other study investigating LY2624803 after receiving study drug
* Known allergies to LY2624803 or related compounds
* Women who are lactating
* Shift workers \[those who shifted or plan to shift work within 7 days of any phase advance polysomnography (PSG) night\] or any person who has crossed (or will have crossed) more than one time zone by aircraft within 3 days prior to e…
What they're measuring
1
Wake After Sleep Onset (WASO) With LY2624803 Compared to Placebo