HealthyPhase 1NCT02603861
A Study of LY3154207 on Sleep in Healthy Male Participants
A Phase 1 study testing LY3154207 and Modafinil in people with Healthy, run by Eli Lilly and Company at 1 site in United States.
Trial summary
This study will evaluate the effect of single doses of LY3154207 on the amount of time it takes for healthy sleep-deprived men to fall asleep. The study will also estimate how much LY3154207 gets into the blood stream and how long it takes the body to remove it. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY3154207 and Modafinil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Mar 2016
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overtly healthy males 18 years of age or older who have given consent and are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
- Have a regular sleep pattern with routine time spent in bed between 6.5 hours and 9 hours each night
Who cannot join
- Are shift workers who shifted work within 14 days prior to screening or plan to during the study
- Have a known sleep disorder or history of a sleep disorder
- Have traveled 2 time zones or more within 7 days prior to screening or plan to during the study
- Regularly take naps during the day
- Are hearing impaired
Trial locations and contacts
1 site in 1 country.
United States1 site
Parexel Early Phase Unit at Glendale
Glendale, California, 91206
About this study
Official title: An Evaluation of the Impact of Single Doses of LY3154207 on Sleep Latency in Sleep-Deprived Healthy Subjects
This study will evaluate the effect of single doses of LY3154207 on the amount of time it takes for healthy sleep-deprived men to fall asleep. The study will also estimate how much LY3154207 gets into the blood stream and how long it takes the body to remove it. Information about any side effects that occur will be collected. Each participant will complete four study periods, which will last a total of about 8 weeks.
- Conditions
- Healthy
- Being tested
- LY3154207, Placebo, Modafinil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3154207Drug
LY3154207 administered orally.
PlaceboDrug
Placebo administered orally.
ModafinilDrug
Modafinil administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo matching LY3154207 administered once orally in one of four periods. Receives: Drug: Placebo |
| LY3154207 - Dose 1 | Experimental | LY3154207 administered orally in no more than one of the four periods. Receives: Drug: LY3154207 |
| LY3154207 - Dose 2 | Experimental | LY3154207 administered orally in no more than one of the four periods. Receives: Drug: LY3154207 |
| LY3154207 - Dose 3 | Experimental | LY3154207 administered orally in no more than one of the four periods. Receives: Drug: LY3154207 |
| Modafinil | Active comparator | 200 mg modafinil administered orally in no more than one of the four periods. Receives: Drug: Modafinil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Sleep Onset
Measured: Day 1: 2 hours post dose through 8 hours post dose in each period.
Secondary outcomes (2)
Maximum Concentration (Cmax) of LY3154207
Measured: Day 1: 1 hour post dose through 24 hours post dose in each period.
Area Under the Concentration Versus Time Curve (AUC) of LY3154207
Measured: Day 1: 1 hour post dose through 24 hours post dose in each period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 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
- NCT02603861
- Sponsor's protocol ID
- 15511
- Other IDs
- I7S-EW-HBEB
- Status last verified
- Apr 2016
- First submitted
- 11 Nov 2015
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Impact of Single Doses of LY3154207 on Sleep Latency in Sleep-Deprived Healthy Subjects
- ClinicalTrials.gov ID
- NCT02603861
- Acronym / sponsor ID
- 15511
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 13 Nov 2015 (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.
This study will evaluate the effect of single doses of LY3154207 on the amount of time it takes for healthy sleep-deprived men to fall asleep. The study will also estimate how much LY3154207 gets into the blood stream and how long it takes the body to remove it. Information about any side effects that occur will be collected. Each participant will complete four study periods, which will last a total of about 8 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo matching LY3154207 administered once orally in one of four periods. |
| LY3154207 - Dose 1 | Experimental | Drug: LY3154207LY3154207 administered orally in no more than one of the four periods. |
| LY3154207 - Dose 2 | Experimental | Drug: LY3154207LY3154207 administered orally in no more than one of the four periods. |
| LY3154207 - Dose 3 | Experimental | Drug: LY3154207LY3154207 administered orally in no more than one of the four periods. |
| Modafinil | Active comparator | Drug: Modafinil200 mg modafinil administered orally in no more than one of the four periods. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Overtly healthy males 18 years of age or older who have given consent and are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
- Have a regular sleep pattern with routine time spent in bed between 6.5 hours and 9 hours each night
Key exclusion criteria (5 listed)
- Are shift workers who shifted work within 14 days prior to screening or plan to during the study
- Have a known sleep disorder or history of a sleep disorder
- Have traveled 2 time zones or more within 7 days prior to screening or plan to during the study
- Regularly take naps during the day
- Are hearing impaired
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 |
|---|---|---|
| LY3154207LY3154207 administered orally. | Drug | LY3154207 - Dose 1, LY3154207 - Dose 2, LY3154207 - Dose 3 |
| PlaceboPlacebo administered orally. | Drug | Placebo |
| ModafinilModafinil administered orally. | Drug | Modafinil |
Primary outcome
Time to Sleep Onset
Time frame: Day 1: 2 hours post dose through 8 hours post dose in each period.
2 secondary outcomes
Maximum Concentration (Cmax) of LY3154207
Time frame: Day 1: 1 hour post dose through 24 hours post dose in each period.
Area Under the Concentration Versus Time Curve (AUC) of LY3154207
Time frame: Day 1: 1 hour post dose through 24 hours post dose in each period.
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 6 Apr 2016.
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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 LY3154207 and Modafinil in people with Healthy, run by Eli Lilly and Company at 1 site in United States.
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 2 inclusion and 5 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 6 Apr 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 United States. 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?
Time to Sleep Onset (time frame: Day 1: 2 hours post dose through 8 hours post dose in each period.). 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 6 Apr 2016; AzTrials last refreshed its copy on 8 Nov 2026.