HealthyPhase 1NCT05222399
A Study of LY3871801 in Healthy Participants
A Phase 1 study testing LY3871801 in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.
Trial summary
The main purpose of this study is to compare the amount of LY3871801 that gets into the blood stream and how long it takes the body to get rid of it, when given as crystalline freebase tablet (test) and as a solid dispersion oral suspension (reference) in healthy participants. Read more about this study
- Who is it for?
- Ages 21 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?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSingapore
- Study dates
- 4 Feb 2022to 11 Mar 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants who are overtly healthy as determined by medical evaluation including medical history and physical examination.
- Have body weight ≥ 45 kilograms (kg) and body mass index (BMI) within the range 18.5 to 40.0 kilograms per meter squared (kg/m²)
- Participants not of childbearing potential
Who cannot join
- Have known allergies to LY3871801, related compounds or any components of the formulation, or history of significant atopy.
- Have an abnormal blood pressure and/or pulse rate, deemed to be clinically significant by the investigator
- Have used or intend to use prescription or nonprescription medication (including dietary supplements, vitamins, herbal supplements, and/or alternative medicines) within 7 days prior to dosing
- History of drug or alcohol abuse in the past 2 years and/or regularly use known drugs of abuse
- Are unwilling to stop alcohol consumption 24 hours prior to admission and while resident at the clinical research unit (CRU).
- Smoke more than 10 cigarettes per day (or the equivalent, including electronic cigarettes) or are unable to abide by the CRU smoking restrictions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics of LY3871801 Following Oral Administration of a Crystalline Freebase Tablet and a Solid Dispersion Oral Suspension
The main purpose of this study is to compare the amount of LY3871801 that gets into the blood stream and how long it takes the body to get rid of it, when given as crystalline freebase tablet (test) and as a solid dispersion oral suspension (reference) in healthy participants. The information about any adverse effects experienced will be collected and the tolerability of LY3871801 will also be evaluated. The study may last up to approximately 15 days excluding the 28 days of screening period.
- Conditions
- Healthy
- Being tested
- LY3871801
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3871801Drug
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| LY3871801 (Period 1) | Experimental | LY3871801 solid dispersion suspension administered orally. Receives: Drug: LY3871801 |
| LY3871801 (Period 2) | Experimental | LY3871801 crystalline freebase tablet administered orally. Receives: Drug: LY3871801 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3871801
PK: Cmax of LY3871801
Measured: Predose through Day 4
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3871801
PK: AUC[0-∞] of LY3871801
Measured: Predose through Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start4 Feb 2022
- Primary completion11 Mar 2022
- Study completion11 Mar 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT05222399
- Sponsor's protocol ID
- 18323
- Other IDs
- J3P-MC-FTAB
- Status last verified
- Mar 2022
- First submitted
- 24 Jan 2022
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of LY3871801 Following Oral Administration of a Crystalline Freebase Tablet and a Solid Dispersion Oral Suspension
- ClinicalTrials.gov ID
- NCT05222399
- Acronym / sponsor ID
- 18323
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2022 (actual)
- Primary completion
- 11 Mar 2022 (actual)
- Study completion
- 11 Mar 2022 (actual)
- First posted
- 3 Feb 2022 (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 compare the amount of LY3871801 that gets into the blood stream and how long it takes the body to get rid of it, when given as crystalline freebase tablet (test) and as a solid dispersion oral suspension (reference) in healthy participants. The information about any adverse effects experienced will be collected and the tolerability of LY3871801 will also be evaluated. The study may last up to approximately 15 days excluding the 28 days of screening period.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY3871801 (Period 1) | Experimental | Drug: LY3871801LY3871801 solid dispersion suspension administered orally. |
| LY3871801 (Period 2) | Experimental | Drug: LY3871801LY3871801 crystalline freebase tablet administered orally. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants who are overtly healthy as determined by medical evaluation including medical history and physical examination.
- Have body weight ≥ 45 kilograms (kg) and body mass index (BMI) within the range 18.5 to 40.0 kilograms per meter squared (kg/m²)
- Participants not of childbearing potential
Key exclusion criteria (6 listed)
- Have known allergies to LY3871801, related compounds or any components of the formulation, or history of significant atopy.
- Have an abnormal blood pressure and/or pulse rate, deemed to be clinically significant by the investigator
- Have used or intend to use prescription or nonprescription medication (including dietary supplements, vitamins, herbal supplements, and/or alternative medicines) within 7 days prior to dosing
- History of drug or alcohol abuse in the past 2 years and/or regularly use known drugs of abuse
- Are unwilling to stop alcohol consumption 24 hours prior to admission and while resident at the clinical research unit (CRU).
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 (Period 1), LY3871801 (Period 2) |
Primary outcome
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3871801
Time frame: Predose through Day 4
PK: Cmax of LY3871801
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3871801
Time frame: Predose through Day 4
PK: AUC[0-∞] of LY3871801
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 18 Mar 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 LY3871801 in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.
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 3 inclusion and 6 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 18 Mar 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 Singapore. 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. 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?
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3871801 (time frame: Predose through Day 4). The study lists 2 primary outcomes in all. 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 18 Mar 2022.