A Study of LY2624803 in Participants With Transient Insomnia

NCT01779830 | Completed Phase 1

• 2 other identifiers: 12057I2K-MC-ZZAA
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Transient Insomnia

Outcome Measures

Primary Outcomes (1)

• Change in Wake After Sleep Onset (WASO) With LY2624803 Compared to Placebo

  Baseline up to Day 60

Secondary Outcomes (2)

• 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

Study Arms (5)

0.3 mg LY2624803

EXPERIMENTAL

Single dose of 0.3 mg LY2624803 administered orally in up to 2 of 4 treatment periods.

Drug: LY2624803 - Capsules

3.0 mg LY2624803

EXPERIMENTAL

Single dose of 3.0 mg LY2624803 administered orally in up to 2 of 4 treatment periods.

Drug: LY2624803 - Capsules

6.0 mg LY2624803

EXPERIMENTAL

Single dose of 6.0 mg LY2624803 administered orally in up to 2 of 4 treatment periods.

Drug: LY2624803 - Capsules

10 mg Zolpidem

ACTIVE COMPARATOR

Single dose of 10 mg zolpidem administered orally in up to 1 of 4 treatment periods.

Drug: Zolpidem - Tablets

Placebo

PLACEBO COMPARATOR

Single dose of placebo administered orally in up to 1 of 4 treatment periods.

Drug: Placebo - Capsules; Drug: Placebo - Tablets

Interventions

LY2624803 - Capsules DRUG

Administered orally as capsules.

Also known as: Hypnion

0.3 mg LY2624803; 3.0 mg LY2624803; 6.0 mg LY2624803

Zolpidem - Tablets DRUG

Administered orally as tablets.

10 mg Zolpidem

Placebo - Capsules DRUG

Administered orally as capsules.

Placebo

Placebo - Tablets DRUG

Administered orally as tablets.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Venous access sufficient to allow blood sampling
• Are reliable and willing to make themselves available for the duration of the study
• Have given written informed consent approved by Lilly and the ethical review board governing the site

You may not qualify if:

• 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
• Within 3 months of the initial dose of study drug, have received treatment with a drug that has not received regulatory approval for any indication
• Participants with postural hypotension at screening
• Participants with a history of postural hypotension, loss of consciousness, explained or unexplained syncope or seizure episodes or a family history of seizures. History of a single febrile convulsion is acceptable
• Known allergies to LY2624803, Zolpidem or related compounds
• Persons who have previously completed or withdrawn from this study or any other study investigating LY2624803

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (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

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2013
• First Posted: January 30, 2013
• Study Start: May 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: January 30, 2013

Record last verified: 2013-01

Locations

FR (1)