Sleep Initiation and Maintenance DisordersPhase 1NCT01784614

A Study of LY2624803 in Japanese Participants With Transient Insomnia

A Phase 1 study testing LY2624803 - Solution and LY2624803 - Capsule in people with Sleep Initiation and Maintenance Disorders, run by Eli Lilly and Company at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Sleep Initiation and Maintenance Disorders
What is being tested?: LY2624803 - Solution and LY2624803 - Capsule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteJapan
Study dates: Sep 2009to Mar 2010
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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 an irregular or altered sleep/wake schedule that is likely to prevent from keeping a regular sleep/wake schedule during the study

Show all 32Show fewer

Regular napping (≥ 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

Trial locations and contacts

1 site in 1 country.

Japan1 site

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

Other trials in Japan

About this study

Official title: Pharmacodynamics and Pharmacokinetics of Single Doses of LY2624803 in a 5-hour Phase Advance Model of Transient Insomnia in Healthy Japanese Subjects

Conditions: Sleep Initiation and Maintenance Disorders
Being tested: LY2624803 - Solution, LY2624803 - Capsule, Placebo - Solution, Placebo - Capsule
Medical subject headings: Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY2624803 - SolutionDrug
Administered orally as reconstituted solution
LY2624803 - CapsuleDrug
Administered orally as a capsule
Placebo - SolutionDrug
Administered orally as solution
Placebo - CapsuleDrug
Administered orally as a capsule

Study groups in NCT01784614
Study group	Role	What they receive
0.1 milligrams (mg) LY2624803	Experimental	Single dose of 0.1 mg LY2624803 administered orally in up to 2 of 4 treatment periods Receives: Drug: LY2624803 - Solution; Drug: Placebo - Capsule
1.0 mg LY2624803	Experimental	Single dose of 1.0 mg LY2624803 administered orally in up to 2 of 4 treatment periods Receives: Drug: LY2624803 - Capsule; Drug: Placebo - Solution
3.0 mg LY2624803	Experimental	Single dose of 3.0 mg LY2624803 administered orally in up to 2 of 4 treatment periods Receives: Drug: LY2624803 - Capsule; Drug: Placebo - Solution
6.0 mg LY2624803	Experimental	Single dose of 6.0 mg LY2624803 administered orally in up to 2 of 4 treatment periods Receives: Drug: LY2624803 - Capsule; Drug: Placebo - Solution
Placebo	Placebo comparator	Single dose of placebo administered orally in up to 1 of 4 treatment periods Receives: Drug: Placebo - Solution; Drug: Placebo - Capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

Wake After Sleep Onset (WASO) With LY2624803 Compared to Placebo
WASO was calculated as total time in awake epochs between sleep onset time (first stage 2 epoch) and the end of the primary recording period (8 hours after lights -off). Data presented are Geometric Least Squares (LS) means. Geometric LS mean was calculated using mixed models analysis. The model included factors for treatment, treatment sequence, period and participants.
Measured: 8 hours in Periods 1, 2 and 3

Secondary outcomes (4)

Latency to Persistent Sleep (LPS)
LPS is defined as the latency from the lights-off time to the first stage 2 sleep followed by at least 10 consecutive minutes of sleep epochs. Data presented are Geometric LS means. Geometric LS mean was calculated using mixed models analysis. The model included factors for treatment, treatment sequence, period and participants.
Measured: 8 hours in Periods 1, 2 and 3
Total Sleep Time (TST)
TST is defined as the total time in sleep epochs from sleep onset time to the end of the primary recording period (8 hours after lights -off). LS mean was calculated using mixed models analysis. The model included factors for treatment, treatment sequence, period and participants.
Measured: 8 hours in Periods 1, 2 and 3
PK: Maximum Plasma Concentration (Cmax) of LY2624803 After Single Oral Dose in Period 4
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 10, 12, 18, and 42 hours post-dose in Period 4
PK: Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)] of LY2624803 After Single Oral Dose in Period 4
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 10, 12, 18, and 42 hours post-dose in Period 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2009Mar 2010

First posted6 Feb 2013 (estimated)
Study startSep 2009
Primary completionMar 2010
Study completionMar 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01784614
Sponsor's protocol ID: 12662
Other IDs: I2K-JE-ZZAW
Status last verified: Dec 2015
First submitted: 4 Feb 2013
Last updated: 28 Jan 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sleep Initiation and Maintenance Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacodynamics and Pharmacokinetics of Single Doses of LY2624803 in a 5-hour Phase Advance Model of Transient Insomnia in Healthy Japanese Subjects
ClinicalTrials.gov ID: NCT01784614
Acronym / sponsor ID: 12662
Conditions: Sleep Initiation and Maintenance Disorders
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Sep 2009
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 6 Feb 2013 (estimated)
Results: Posted 28 Jan 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
0.1 milligrams (mg) LY2624803	Experimental	Drug: LY2624803 - Solution, Drug: Placebo - CapsuleSingle dose of 0.1 mg LY2624803 administered orally in up to 2 of 4 treatment periods
1.0 mg LY2624803	Experimental	Drug: LY2624803 - Capsule, Drug: Placebo - SolutionSingle dose of 1.0 mg LY2624803 administered orally in up to 2 of 4 treatment periods
3.0 mg LY2624803	Experimental	Drug: LY2624803 - Capsule, Drug: Placebo - SolutionSingle dose of 3.0 mg LY2624803 administered orally in up to 2 of 4 treatment periods
6.0 mg LY2624803	Experimental	Drug: LY2624803 - Capsule, Drug: Placebo - SolutionSingle dose of 6.0 mg LY2624803 administered orally in up to 2 of 4 treatment periods
Placebo	Placebo comparator	Drug: Placebo - Solution, Drug: Placebo - CapsuleSingle dose of placebo administered orally in up to 1 of 4 treatment periods

Who may qualify

Ages: 20 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (32 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY2624803 - SolutionAdministered orally as reconstituted solution	Drug	0.1 milligrams (mg) LY2624803
LY2624803 - CapsuleAdministered orally as a capsule	Drug	1.0 mg LY2624803, 3.0 mg LY2624803, 6.0 mg LY2624803
Placebo - SolutionAdministered orally as solution	Drug	1.0 mg LY2624803, 3.0 mg LY2624803, 6.0 mg LY2624803, Placebo
Placebo - CapsuleAdministered orally as a capsule	Drug	0.1 milligrams (mg) LY2624803, Placebo

Primary outcome

Wake After Sleep Onset (WASO) With LY2624803 Compared to Placebo
Time frame: 8 hours in Periods 1, 2 and 3
WASO was calculated as total time in awake epochs between sleep onset time (first stage 2 epoch) and the end of the primary recording period (8 hours after lights -off). Data presented are Geometric Least Squares (LS) means. Geometric LS mean was calculated using mixed models analysis. The model included factors for treatment, treatment sequence, period and participants.

4 secondary outcomes

Latency to Persistent Sleep (LPS)
Time frame: 8 hours in Periods 1, 2 and 3
Total Sleep Time (TST)
Time frame: 8 hours in Periods 1, 2 and 3
PK: Maximum Plasma Concentration (Cmax) of LY2624803 After Single Oral Dose in Period 4
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 10, 12, 18, and 42 hours post-dose in Period 4
PK: Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)] of LY2624803 After Single Oral Dose in Period 4
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 10, 12, 18, and 42 hours post-dose in Period 4

Results and safety

Results posted to the registry on 28 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1	3	3
Cohort 2	3	3
Cohort 3	3	3
Cohort 4	3	3
Cohort 5	3	3
Cohort 6	3	3
Cohort 7	3	3
Cohort 8	3	3

Primary outcome: Wake After Sleep Onset (WASO) With LY2624803 Compared to Placebo

Time frame: 8 hours in Periods 1, 2 and 3. Geometric mean (90% Confidence Interval). Unit: minutes (min)

Measure	0.1 mg LY2624803 n = 8	1.0 mg LY2624803 n = 17	3.0 mg LY2624803 n = 16	6.0 mg LY2624803 n = 8	Placebo n = 17
Value	58.88 (33.32 to 104.05)	40.70 (25.67 to 64.54)	32.27 (20.27 to 51.37)	18.42 (10.44 to 32.51)	61.10 (38.60 to 96.72)

0.1 mg LY2624803 vs Placebo: Ratio of Geometric LS mean: 0.96 (90% CI 0.56 to 1.65), p = 0.908, Mixed Models Analysis
1.0 mg LY2624803 vs Placebo: Ratio of Geometric LS mean: 0.67 (90% CI 0.45 to 0.98), p = 0.083, Mixed Models Analysis
3.0 mg LY2624803 vs Placebo: Ratio of Geometric LS mean: 0.53 (90% CI 0.36 to 0.78), p = 0.010, Mixed Models Analysis

Population analysed: All randomized participants who received at least 1 dose of study drug and had PSG measurements in Periods 1, 2 and 3.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
0.1 mg LY2624803 - Periods 1-3	0 of 9 (0%)	2 of 9 (22.2%)	Not reported
1.0 mg LY2624803 - Periods 1-3	0 of 17 (0%)	3 of 17 (17.6%)	Not reported
3.0 mg LY2624803 - Periods 1-3	0 of 17 (0%)	3 of 17 (17.6%)	Not reported
6.0 mg LY2624803 - Periods 1-3	0 of 8 (0%)	0 of 8 (0%)	Not reported
Placebo - Periods 1-3	0 of 18 (0%)	3 of 18 (16.7%)	Not reported
0.1 mg LY2624803 - Period 4	0 of 6 (0%)	0 of 6 (0%)	Not reported
1.0 mg LY2624803 - Period 4	0 of 5 (0%)	2 of 5 (40%)	Not reported
3.0 mg LY2624803 - Period 4	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
6 mg LY2624803 - Period 4	0 of 5 (0%)	3 of 5 (60%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY2624803 - Solution and LY2624803 - Capsule in people with Sleep Initiation and Maintenance Disorders, run by Eli Lilly and Company at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wake After Sleep Onset (WASO) With LY2624803 Compared to Placebo (time frame: 8 hours in Periods 1, 2 and 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01784614.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2016.