Transient InsomniaPhase 1NCT01779830
A Study of LY2624803 in Participants With Transient Insomnia
A Phase 1 study testing LY2624803 - Capsules and Zolpidem - Tablets in people with Transient Insomnia, run by Eli Lilly and Company at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Transient Insomnia
- What is being tested?
- LY2624803 - Capsules and Zolpidem - Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- May 2008to Nov 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
- An abnormality in the 12-lead electrocardiogram (ECG) that increases the risks associated with participating in the study
- 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
- Any other condition with in the opinion of the investigator would preclude participation 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
- Women with a positive pregnancy test
- Women who are lactating
- Use of prescription, over the counter or herbal medications that cannot safely be discontinued within 28 days prior to enrollment
- Blood donation of more than 500 milliliter (mL) within the last month
- History of smoking within the previous 6 months of screening
- Participants who have an average weekly alcohol intake that exceeds 28 units per week (males) and 21 units per week (females), or participants unwilling to stop alcohol consumption for the duration of the study
Trial locations and contacts
1 site in 1 country.
France1 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.
Rouffach
About this study
Official title: 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
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
- Being tested
- LY2624803 - Capsules, Zolpidem - Tablets, Placebo - Capsules, Placebo - Tablets
- 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 - CapsulesDrug
Also called Hypnion
Administered orally as capsules.
Zolpidem - TabletsDrug
Administered orally as tablets.
Placebo - CapsulesDrug
Administered orally as capsules.
Placebo - TabletsDrug
Administered orally as tablets.
| Study group | Role | What they receive |
|---|---|---|
| 0.3 mg LY2624803 | Experimental | Single dose of 0.3 mg LY2624803 administered orally in up to 2 of 4 treatment periods. Receives: 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. Receives: 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. Receives: Drug: LY2624803 - Capsules |
| 10 mg Zolpidem | Active comparator | Single dose of 10 mg zolpidem administered orally in up to 1 of 4 treatment periods. Receives: Drug: Zolpidem - Tablets |
| Placebo | Placebo comparator | Single dose of placebo administered orally in up to 1 of 4 treatment periods. Receives: Drug: Placebo - Capsules; Drug: Placebo - Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Wake After Sleep Onset (WASO) With LY2624803 Compared to Placebo
Measured: Baseline up to Day 60
Secondary outcomes (2)
Latency to Persistent Sleep (LPS) with LY2624803 Compared to Placebo
Measured: Baseline up to Day 60
Total Sleep Time (TST) with LY2624803 Compared to Placebo
Measured: Baseline up to Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startMay 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transient InsomniaStudies 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779830
- Sponsor's protocol ID
- 12057
- Other IDs
- I2K-MC-ZZAA
- Status last verified
- Jan 2013
- First submitted
- 25 Jan 2013
- Last updated
- 30 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01779830
- Acronym / sponsor ID
- 12057
- Conditions
- Transient Insomnia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 30 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 0.3 mg LY2624803 | Experimental | Drug: LY2624803 - CapsulesSingle dose of 0.3 mg LY2624803 administered orally in up to 2 of 4 treatment periods. |
| 3.0 mg LY2624803 | Experimental | Drug: LY2624803 - CapsulesSingle dose of 3.0 mg LY2624803 administered orally in up to 2 of 4 treatment periods. |
| 6.0 mg LY2624803 | Experimental | Drug: LY2624803 - CapsulesSingle dose of 6.0 mg LY2624803 administered orally in up to 2 of 4 treatment periods. |
| 10 mg Zolpidem | Active comparator | Drug: Zolpidem - TabletsSingle dose of 10 mg zolpidem administered orally in up to 1 of 4 treatment periods. |
| Placebo | Placebo comparator | Drug: Placebo - Capsules, Drug: Placebo - TabletsSingle dose of placebo administered orally in up to 1 of 4 treatment periods. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (28 listed)
- 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)
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 - CapsulesAlso: HypnionAdministered orally as capsules. | Drug | 0.3 mg LY2624803, 3.0 mg LY2624803, 6.0 mg LY2624803 |
| Zolpidem - TabletsAdministered orally as tablets. | Drug | 10 mg Zolpidem |
| Placebo - CapsulesAdministered orally as capsules. | Drug | Placebo |
| Placebo - TabletsAdministered orally as tablets. | Drug | Placebo |
Primary outcome
Change in Wake After Sleep Onset (WASO) With LY2624803 Compared to Placebo
Time frame: Baseline up to Day 60
2 secondary outcomes
Latency to Persistent Sleep (LPS) with LY2624803 Compared to Placebo
Time frame: Baseline up to Day 60
Total Sleep Time (TST) with LY2624803 Compared to Placebo
Time frame: Baseline up to Day 60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2013.
Related trials for Transient Insomnia
Active, not recruiting
Sleep Restriction Therapy for Insomnia in Primary Health Care
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Not yet recruitingPhase 2
SM-1 vs. an Active Comparator in A Model of Transient Insomnia
Transient Insomnia
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 - Capsules and Zolpidem - Tablets in people with Transient Insomnia, run by Eli Lilly and Company at 1 site in France.
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 13 inclusion and 28 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 30 Jan 2013. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Wake After Sleep Onset (WASO) With LY2624803 Compared to Placebo (time frame: Baseline up to Day 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2013.