Trial record 16 of 344 for:
"Sleep Initiation and Maintenance Disorders"
A Study of LY2624803 in Japanese Participants With Transient Insomnia
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01784614
First received: February 4, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sleep Initiation and Maintenance Disorders |
Drug: LY2624803 - Solution Drug: LY2624803 - Capsules Drug: Placebo - Solution Drug: Placebo - Capsules |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) |
| Official Title: | Pharmacodynamics and Pharmacokinetics of Single Doses of LY2624803 in a 5-hour Phase Advance Model of Transient Insomnia in Healthy Japanese Subjects |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Change in Wake After Sleep Onset (WASO) With LY2624803 Compared to Placebo [ Time Frame: Baseline up to Day 60 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Latency to Persistent Sleep (LPS) and Total Sleep Time (TST) with LY2624803 Compared to Placebo [ Time Frame: Baseline up to Day 60 ] [ Designated as safety issue: No ]
| Enrollment: | 24 |
| Study Start Date: | September 2009 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 0.1 mg LY2624803
Single dose of 0.1 mg LY2624803 administered orally in up to 2 of 4 treatment periods
|
Drug: LY2624803 - Solution
Administered orally as reconstituted solution
Other Name: Hypnion
Drug: LY2624803 - Capsules
Administered orally as capsules
Other Name: Hypnion
|
|
Experimental: 1.0 mg LY2624803
Single dose of 1.0 mg LY2624803 administered orally in up to 2 of 4 treatment periods
|
Drug: LY2624803 - Solution
Administered orally as reconstituted solution
Other Name: Hypnion
Drug: LY2624803 - Capsules
Administered orally as capsules
Other Name: Hypnion
|
|
Experimental: 3.0 mg LY2624803
Single dose of 3.0 mg LY2624803 administered orally in up to 2 of 4 treatment periods
|
Drug: LY2624803 - Solution
Administered orally as reconstituted solution
Other Name: Hypnion
Drug: LY2624803 - Capsules
Administered orally as capsules
Other Name: Hypnion
|
|
Experimental: 6.0 mg LY2624803
Single dose of 6.0 mg LY2624803 administered orally in up to 2 of 4 treatment periods
|
Drug: LY2624803 - Solution
Administered orally as reconstituted solution
Other Name: Hypnion
Drug: LY2624803 - Capsules
Administered orally as capsules
Other Name: Hypnion
|
|
Placebo Comparator: Placebo
Single dose of placebo administered orally in up to 1 of 4 treatment periods
|
Drug: Placebo - Solution
Administered orally as solution
Drug: Placebo - Capsules
Administered orally as capsules
|
Eligibility| Ages Eligible for Study: | 20 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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 entry
- Have a irregular or altered sleep/wake schedule that is likely to prevent from keeping a regular sleep/wake schedule during the study
- Regular napping (greater than [≥] 2 daytime naps/week by history)
- Extreme morning type or evening type
- Rhinitis, conjunctivitis, urticaria or chronic pain severe enough to interfere with sleep
- Nocturia that would interfere with sleep assessment
- Symptoms consistent with a sleep disorder or history of same
- 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
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neurocardiogenic or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
- History or presence of orthostatic signs and symptoms within 2 years
- History of seizure or a close relative having a seizure disorder (such as epilepsy). History of a single febrile convulsion more than 10 years ago is acceptable. History of cranial trauma and loss of consciousness will be discussed prior to including any such participant
- Abnormal movements observed outside of normal sleep time
- Abnormal supine blood pressure and/or pulse rate
- Participants with orthostatic hypotension at screening
- An abnormality in the 12-lead electrocardiogram (ECG) that increases the risks associated with participating in the study
- Regular use of known drugs of abuse and/or positive findings on urinary drug screening
- Evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies
- Evidence of hepatitis C and/or positive hepatitis C antibody
- Evidence of hepatitis B and/or positive hepatitis B surface antigen
- Evidence of syphilis infection and/or positive syphilis test
- Use or intended use of prescription (except oral contraceptives), over-the-counter or herbal medication, specifically antihistamines, anticholinergic medications or any medications that affect sleepiness, within 28 days prior to Period 1 dosing and/or during the study
- Participants who have donated more than 200 milliliters (mL) of blood or component blood within one month of screening, or those who have donated more than 400 mL of blood within 3 months of screening
- History of smoking within the previous 6 months of screening
- Participants who have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females), or participants unwilling to stop alcohol consumption for the period
- Participants whose daily caffeine intake does not permit maintenance of usual sleep/wake schedule
- No response to phase advance or a placebo responder
- Sleep disorders detected during the PSG screening night
- History or presence of breast cancer
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01784614
Locations
| Japan | |
| 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. | |
| Sagamihara, Japan | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| 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 |
More Information
No publications provided
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT01784614 History of Changes |
| Other Study ID Numbers: | 12662, I2K-JE-ZZAW |
| Study First Received: | February 4, 2013 |
| Last Updated: | February 4, 2013 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Additional relevant MeSH terms:
|
Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias |
Sleep Disorders Nervous System Diseases Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013