HealthyPhase 1NCT04258826
A Study to Evaluate LY3154207 on the Brain of Healthy Participants
A Phase 1 study testing LY3154207 in people with Healthy, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The purpose of this study is to learn more about how LY3154207 affects the brain of healthy participants by using magnetic resonance imaging. The study will last up to about nine weeks for each participant and may include up to four visits to the study center. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY3154207
- 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
- 15 Jan 2021to 28 Jan 2022
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -Overtly healthy males and non-childbearing females, as determined through medical history and physical examination
Who cannot join
- Have known or ongoing psychiatric disorders
- Have contraindications to magnetic resonance imaging (MRI)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Dose Study Using Functional Magnetic Resonance Imaging to Evaluate the Effect of LY3154207 in Healthy Subjects
The purpose of this study is to learn more about how LY3154207 affects the brain of healthy participants by using magnetic resonance imaging. The study will last up to about nine weeks for each participant and may include up to four visits to the study center.
- Conditions
- Healthy
- Being tested
- LY3154207, Placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| LY3154207 | Experimental | LY3154207 administered orally in one of two study periods. Receives: Drug: LY3154207 |
| Placebo | Placebo comparator | Placebo administered orally in one of two study periods. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Intrinsic Functional Connectivity Among Resting-State Networks of the Brain
Mean Connectivity and Mean Component Weight Between LY3154207 and Placebo in the Dorsal Attention Network (DAN), Frontoparietal Network (FPN), and Executive Control Network (ECN).
Measured: Day 1, Approximately Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start15 Jan 2021
- Primary completion28 Jan 2022
- Study completion28 Jan 2022
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
- NCT04258826
- Sponsor's protocol ID
- 17294
- Other IDs
- I7S-MC-HBEM
- Status last verified
- 15 Feb 2022
- First submitted
- 5 Feb 2020
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose Study Using Functional Magnetic Resonance Imaging to Evaluate the Effect of LY3154207 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04258826
- Acronym / sponsor ID
- 17294
- 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
- 15 Jan 2021 (actual)
- Primary completion
- 28 Jan 2022 (actual)
- Study completion
- 28 Jan 2022 (actual)
- First posted
- 6 Feb 2020 (actual)
- 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 purpose of this study is to learn more about how LY3154207 affects the brain of healthy participants by using magnetic resonance imaging. The study will last up to about nine weeks for each participant and may include up to four visits to the study center.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY3154207 | Experimental | Drug: LY3154207LY3154207 administered orally in one of two study periods. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered orally in one of two study periods. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -Overtly healthy males and non-childbearing females, as determined through medical history and physical examination
Key exclusion criteria (2 listed)
- Have known or ongoing psychiatric disorders
- Have contraindications to magnetic resonance imaging (MRI)
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 |
| PlaceboPlacebo administered orally. | Drug | Placebo |
Primary outcome
Change from Baseline in Intrinsic Functional Connectivity Among Resting-State Networks of the Brain
Time frame: Day 1, Approximately Day 28
Mean Connectivity and Mean Component Weight Between LY3154207 and Placebo in the Dorsal Attention Network (DAN), Frontoparietal Network (FPN), and Executive Control Network (ECN).
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 22 Feb 2022.
- Individual participant dataSharing planned: No
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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 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 1 inclusion and 2 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 22 Feb 2022. 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?
Change from Baseline in Intrinsic Functional Connectivity Among Resting-State Networks of the Brain (time frame: Day 1, Approximately Day 28). 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 22 Feb 2022.