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A Study of LY2624803 in Participants With Transient Insomnia | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study of LY2624803 in Participants With Transient Insomnia

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Crossover Study of Single Doses of LY2624803 in a 5-hour Phase Advance Model of Transient Insomnia in Healthy Subjects

NCT01779830•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The aim of this study is to learn how different doses of LY2624803 affect sleep in healthy people. The study has four treatment periods. Participants will receive a single dose of LY2624803, another sleeping pill, or placebo in each treatment period. The study will last approximately 1 month for each participant.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Overtly healthy males or females
•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 one month following the last dose of study drug
•Between the Body Mass Index (BMI) of 19 and 30 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
•Participants whose daily caffeine intake permits maintenance of normal bed time hours
•Non response to placebo defined as a Wake After Sleep Onset (WASO) of greater than or equal to 45 minutes, on a 5-hour phase-advanced polysomnography (PSG) screening night after bedtime single-blind placebo administration
•Males must agree to use effective barrier contraception during the course of the trial and 3 months later
•Participants over 65 years of age, on a stable dose of one medication for lowering cholesterol, triglycerides and/or one medication for lowering blood pressure and/or substitutive hormonal therapy in post menopausal women are allowed provided those treatments have no central effect
•Clinical laboratory test results within normal reference range judged to be not clinically significant
•Normal sitting blood pressure and pulse rate as determined
+3 more criteria

Exclusion Criteria

•Shift workers (those who shifted work within 7 days of any PSG night) or any person who has crossed (or will have crossed) more than one time zone by aircraft within 3 days prior to entry
•Rhinoconjunctivitis, urticaria or chronic pain severe enough to interfere with sleep
•Nocturia that would interfere with sleep assessment
•Participants with allergic conjunctivitis or urticaria
•Regular napping (greater than (≥) 2 daytime naps/week by history)
•Symptoms consistent with a sleep disorder or history of same
•Sleep disorders detected during the screening night
•Evidence of significant active neuropsychiatric disease and in particular evidence of significant medical or psychiatric illness within the past 12 months that could contribute to insomnia
•Irregular or altered sleep/wake schedule
•Known history of fainting or low blood pressure. History of cranial trauma and loss of consciousness will be discussed prior to including any such participant
+18 more criteria

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Rouffach, France

Key Dates

Start Date

May 1, 2008

Primary Completion Date

November 1, 2008

Completion Date

November 1, 2008

Last Updated

January 30, 2013

Enrollment

ACTUAL participants

Conditions

Transient Insomnia

Interventions

LY2624803 - Capsules

DRUG

Zolpidem - Tablets

DRUG

Placebo - Capsules

DRUG

Placebo - Tablets

DRUG

A Polysomnographic Study of Single-Dose Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance

NCT00666770

Transient Insomnia

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COMPLETEDPHASE3

A 28-Day Polysomnographic Study of Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance

NCT00163046

Transient Insomnia

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NOT_YET_RECRUITINGPHASE2

SM-1 vs. an Active Comparator in A Model of Transient Insomnia

NCT04396327

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of LY2624803 in Participants With Transient Insomnia

Inclusion Criteria

Exclusion Criteria

A Polysomnographic Study of Single-Dose Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance

A 28-Day Polysomnographic Study of Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance

SM-1 vs. an Active Comparator in A Model of Transient Insomnia

Evaluation of Vestibular Stimulation to Help Occasional Sleeplessness