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
Overview
- Phase
- Phase 1
- Intervention
- LY2624803 - Capsules
- Conditions
- Transient Insomnia
- Sponsor
- Eli Lilly and Company
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Change in Wake After Sleep Onset (WASO) With LY2624803 Compared to Placebo
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
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
Arms & Interventions
0.3 mg LY2624803
Single dose of 0.3 mg LY2624803 administered orally in up to 2 of 4 treatment periods.
Intervention: LY2624803 - Capsules
3.0 mg LY2624803
Single dose of 3.0 mg LY2624803 administered orally in up to 2 of 4 treatment periods.
Intervention: LY2624803 - Capsules
6.0 mg LY2624803
Single dose of 6.0 mg LY2624803 administered orally in up to 2 of 4 treatment periods.
Intervention: LY2624803 - Capsules
10 mg Zolpidem
Single dose of 10 mg zolpidem administered orally in up to 1 of 4 treatment periods.
Intervention: Zolpidem - Tablets
Placebo
Single dose of placebo administered orally in up to 1 of 4 treatment periods.
Intervention: Placebo - Capsules
Placebo
Single dose of placebo administered orally in up to 1 of 4 treatment periods.
Intervention: Placebo - Tablets
Outcomes
Primary Outcomes
Change in Wake After Sleep Onset (WASO) With LY2624803 Compared to Placebo
Time Frame: Baseline up to Day 60
Secondary Outcomes
- Latency to Persistent Sleep (LPS) with LY2624803 Compared to Placebo(Baseline up to Day 60)
- Total Sleep Time (TST) with LY2624803 Compared to Placebo(Baseline up to Day 60)