HealthyPhase 1NCT05960851
A Study of LY3871801 in Healthy Asian and Non-Asian Participants
A Phase 1 study testing LY3871801 in people with Healthy, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The main purpose of this study is to evaluate the safety and tolerability of LY3871801 when administered as multiple doses in Healthy Asian and Non-Asian Participants. The study will also evaluate the amount of LY3871801 that gets into the blood stream and how long it takes the body to get rid of it in these… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY3871801
- 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 siteUnited States
- Study dates
- 9 Aug 2023to 25 Oct 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are Japanese, Chinese, or Non-Asian participants who are overtly healthy as determined by medical evaluation
- Have body weight of >/= 45 kilograms (kg) \& a body mass index (BMI) in the range of 18.5 to 29.5 kilogram per square meter (kg/m²). The Japanese participants must have a body weight of 45 to 85 kg and a BMI of 18.0 to 29.5 kg/m²
Who cannot join
- Have known allergies to LY3871801, related compounds, or any components of the formulation, or history of significant atopy
- Have a significant history of or current cardiovascular or heart failure (based on New York Heart Association Functional Classification), respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
- Are females who are lactating or have a positive pregnancy test at screening or Day 1
- Positive for drug or alcohol screen at screening or Day -1
- Smoke more than 10 cigarettes per day
Trial locations and contacts
1 site in 1 country.
United States1 site
Altasciences Clinical Los Angeles, Inc
Cypress, California, 90630
About this study
Official title: A Phase I, Participant- and Investigator-Blind, Single-center Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of LY3871801 in Healthy Asian and Non-Asian Participants
The main purpose of this study is to evaluate the safety and tolerability of LY3871801 when administered as multiple doses in Healthy Asian and Non-Asian Participants. The study will also evaluate the amount of LY3871801 that gets into the blood stream and how long it takes the body to get rid of it in these participants. The study will be conducted in two parts (A \& B). The study will last up to approximately 24 days excluding the screening period.
- Conditions
- Healthy
- Being tested
- LY3871801, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3871801Drug
Administered orally.
PlaceboDrug
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| LY3871801 (Part A) | Experimental | LY3871801 administered orally in Japanese and Non-Asian Participants. Receives: Drug: LY3871801 |
| Placebo (Part A) | Placebo comparator | Placebo administered orally in Japanese and Non-Asian Participants. Receives: Drug: Placebo |
| LY3871801 (Part B) | Experimental | LY3871801 administered orally in Chinese Participants. Receives: Drug: LY3871801 |
| Placebo (Part B) | Placebo comparator | Placebo administered orally in Chinese Participants. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Measured: Predose up to 24 days post dose
Secondary outcomes (2)
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3871801
PK: Cmax of LY3871801
Measured: Predose on Day 1 up to postdose on Day 17
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3871801
PK: AUC of LY3871801
Measured: Predose on Day 1 up to postdose on Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start9 Aug 2023
- Primary completion25 Oct 2023
- Study completion25 Oct 2023
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
- Parallel groups
- 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
- NCT05960851
- Sponsor's protocol ID
- 18334
- Other IDs
- J3P-MC-FTAC
- Status last verified
- Jan 2024
- First submitted
- 18 Jul 2023
- Last updated
- 10 Jan 2024
- 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 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Participant- and Investigator-Blind, Single-center Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of LY3871801 in Healthy Asian and Non-Asian Participants
- ClinicalTrials.gov ID
- NCT05960851
- Acronym / sponsor ID
- 18334
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 9 Aug 2023 (actual)
- Primary completion
- 25 Oct 2023 (actual)
- Study completion
- 25 Oct 2023 (actual)
- First posted
- 27 Jul 2023 (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 main purpose of this study is to evaluate the safety and tolerability of LY3871801 when administered as multiple doses in Healthy Asian and Non-Asian Participants. The study will also evaluate the amount of LY3871801 that gets into the blood stream and how long it takes the body to get rid of it in these participants. The study will be conducted in two parts (A \& B). The study will last up to approximately 24 days excluding the screening period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LY3871801 (Part A) | Experimental | Drug: LY3871801LY3871801 administered orally in Japanese and Non-Asian Participants. |
| Placebo (Part A) | Placebo comparator | Drug: PlaceboPlacebo administered orally in Japanese and Non-Asian Participants. |
| LY3871801 (Part B) | Experimental | Drug: LY3871801LY3871801 administered orally in Chinese Participants. |
| Placebo (Part B) | Placebo comparator | Drug: PlaceboPlacebo administered orally in Chinese Participants. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Are Japanese, Chinese, or Non-Asian participants who are overtly healthy as determined by medical evaluation
- Have body weight of >/= 45 kilograms (kg) \& a body mass index (BMI) in the range of 18.5 to 29.5 kilogram per square meter (kg/m²). The Japanese participants must have a body weight of 45 to 85 kg and a BMI of 18.0 to 29.5 kg/m²
Key exclusion criteria (5 listed)
- Have known allergies to LY3871801, related compounds, or any components of the formulation, or history of significant atopy
- Have a significant history of or current cardiovascular or heart failure (based on New York Heart Association Functional Classification), respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
- Are females who are lactating or have a positive pregnancy test at screening or Day 1
- Positive for drug or alcohol screen at screening or Day -1
- Smoke more than 10 cigarettes per day
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 |
|---|---|---|
| LY3871801Administered orally. | Drug | LY3871801 (Part A), LY3871801 (Part B) |
| PlaceboAdministered orally. | Drug | Placebo (Part A), Placebo (Part B) |
Primary outcome
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Predose up to 24 days post dose
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
2 secondary outcomes
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3871801
Time frame: Predose on Day 1 up to postdose on Day 17
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3871801
Time frame: Predose on Day 1 up to postdose on Day 17
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 10 Jan 2024.
- 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 LY3871801 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 10 Jan 2024. 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?
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Predose up to 24 days post dose). 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 10 Jan 2024.