HealthyPhase 1NCT06181045
A Study of LY3410738 in Healthy Adult Participants
A Phase 1 study testing LY3410738 in people with Healthy, run by Eli Lilly and Company at 2 sites in United States.
Trial summary
The main purpose of this study is to assess the safety and tolerability of LY3410738 and to look at the amount of the study drug, LY3410738, that gets into the blood stream and how long it takes the body to get rid of it when given in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY3410738
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Feb 2021to 4 Aug 2021
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must have Body mass index (BMI) within the range of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive
- Male and female participants in good health, determined by no clinically significant findings from medical history, 12-lead Electrocardiogram (ECG), vital sign measurements, or clinical laboratory evaluations as assessed by the investigator
- Female participants of non-childbearing potential and male participants who follow standard contraceptive methods
- Must comply with all study procedures, including the 3-night stay at the Clinical Research Unit (CRU) and follow-up phone call
Who cannot join
- History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor
- Positive serologic test for hepatitis B surface antigen (HBsAg), hepatitis B virus immunoglobulin M (HBV IgM) core antibody, hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody at Screening.
- Positive polymerase chain reaction (PCR) test for COVID-19 at Screening
- Known ongoing alcohol and/or drug abuse within 2 years prior to Screening
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee)
- Have previously received LY3410738 in any other study investigating LY3410738, within 30 days prior to Day 1
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Covance Clinical Research Unit
Daytona Beach, Florida, 32117
Covance Clinical Research Unit
Madison, Wisconsin, 53704
About this study
Official title: A Phase 1, Single-Ascending-Dose, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3410738 in Healthy Adult Subjects
The main purpose of this study is to assess the safety and tolerability of LY3410738 and to look at the amount of the study drug, LY3410738, that gets into the blood stream and how long it takes the body to get rid of it when given in healthy adult participants. For each participant, the total duration of the study will be 53 days, including screening.
- Conditions
- Healthy
- Being tested
- LY3410738, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3410738Drug
Administered orally.
PlaceboDrug
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (Treatment A): LY3410738 | Experimental | Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule formulation. Receives: Drug: LY3410738; Drug: Placebo |
| Cohort 2 (Treatment B): LY3410738 | Placebo comparator | Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule formulation. Receives: Drug: LY3410738; Drug: Placebo |
| Cohort 3 (Treatment C): LY3410738 | Experimental | Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation. Receives: Drug: LY3410738; Drug: Placebo |
| Cohort 4 (Treatment D): LY3410738 | Experimental | Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation. Receives: Drug: LY3410738; Drug: Placebo |
| Cohort 5 (Treatment E): LY3410738 | Experimental | Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation. Receives: Drug: LY3410738; Drug: Placebo |
| Cohort 6 (Treatment F): LY3410738 | Experimental | Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation. Receives: Drug: LY3410738; Drug: Placebo |
| Cohort 7 (Treatment G): LY3410738 | Experimental | Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation. Receives: Drug: LY3410738; 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: Baseline through 53 days
Secondary outcomes (4)
Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to 24 Hours Post-dose (AUC0-24) of LY3410738
PK: AUC0-24 of LY3410738
Measured: Pre-dose up to 24 hours post-dose
PK: Area Under the Concentration-time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of LY3410738
PK: AUC0-t of LY3410738
Measured: Pre-dose up to 48 hours post-dose
PK: Maximum Observed Plasma Concentration (Cmax) of LY3410738
PK: Cmax of LY3410738
Measured: Pre-dose up to 48 hours post-dose
PK: Time to Maximum Observed Plasma Concentration (Tmax) of LY3410738
PK: Tmax of LY3410738
Measured: Pre-dose up to 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start24 Feb 2021
- Primary completion4 Aug 2021
- Study completion4 Aug 2021
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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Loxo Oncology, Inc.
- Responsible party
- Sponsor
- Investigators
- Yingying Guo-Avrutin, Study director, Loxo Oncology, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181045
- Sponsor's protocol ID
- LOXO-IDH-20003
- Other IDs
- I9Y-OX-JDHD
- Status last verified
- Dec 2023
- First submitted
- 13 Dec 2023
- Last updated
- 26 Dec 2023
- 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 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Ascending-Dose, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3410738 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06181045
- Acronym / sponsor ID
- LOXO-IDH-20003
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Loxo Oncology, Inc.
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 4 Aug 2021 (actual)
- Study completion
- 4 Aug 2021 (actual)
- First posted
- 26 Dec 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 assess the safety and tolerability of LY3410738 and to look at the amount of the study drug, LY3410738, that gets into the blood stream and how long it takes the body to get rid of it when given in healthy adult participants. For each participant, the total duration of the study will be 53 days, including screening.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (Treatment A): LY3410738 | Experimental | Drug: LY3410738, Drug: PlaceboSingle oral dose of LY3410738 or placebo administered as over-encapsulated capsule formulation. |
| Cohort 2 (Treatment B): LY3410738 | Placebo comparator | Drug: LY3410738, Drug: PlaceboSingle oral dose of LY3410738 or placebo administered as over-encapsulated capsule formulation. |
| Cohort 3 (Treatment C): LY3410738 | Experimental | Drug: LY3410738, Drug: PlaceboSingle oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation. |
| Cohort 4 (Treatment D): LY3410738 | Experimental | Drug: LY3410738, Drug: PlaceboSingle oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation. |
| Cohort 5 (Treatment E): LY3410738 | Experimental | Drug: LY3410738, Drug: PlaceboSingle oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation. |
| Cohort 6 (Treatment F): LY3410738 | Experimental | Drug: LY3410738, Drug: PlaceboSingle oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation. |
| Cohort 7 (Treatment G): LY3410738 | Experimental | Drug: LY3410738, Drug: PlaceboSingle oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Must have Body mass index (BMI) within the range of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive
- Male and female participants in good health, determined by no clinically significant findings from medical history, 12-lead Electrocardiogram (ECG), vital sign measurements, or clinical laboratory evaluations as assessed by the investigator
- Female participants of non-childbearing potential and male participants who follow standard contraceptive methods
- Must comply with all study procedures, including the 3-night stay at the Clinical Research Unit (CRU) and follow-up phone call
Key exclusion criteria (6 listed)
- History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor
- Positive serologic test for hepatitis B surface antigen (HBsAg), hepatitis B virus immunoglobulin M (HBV IgM) core antibody, hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody at Screening.
- Positive polymerase chain reaction (PCR) test for COVID-19 at Screening
- Known ongoing alcohol and/or drug abuse within 2 years prior to Screening
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee)
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 |
|---|---|---|
| LY3410738Administered orally. | Drug | Cohort 1 (Treatment A): LY3410738, Cohort 2 (Treatment B): LY3410738, Cohort 3 (Treatment C): LY3410738, Cohort 4 (Treatment D): LY3410738, Cohort 5 (Treatment E): LY3410738, Cohort 6 (Treatment F): LY3410738, Cohort 7 (Treatment G): LY3410738 |
| PlaceboAdministered orally. | Drug | Cohort 1 (Treatment A): LY3410738, Cohort 2 (Treatment B): LY3410738, Cohort 3 (Treatment C): LY3410738, Cohort 4 (Treatment D): LY3410738, Cohort 5 (Treatment E): LY3410738, Cohort 6 (Treatment F): LY3410738, Cohort 7 (Treatment G): LY3410738 |
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: Baseline through 53 days
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
4 secondary outcomes
Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to 24 Hours Post-dose (AUC0-24) of LY3410738
Time frame: Pre-dose up to 24 hours post-dose
PK: Area Under the Concentration-time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of LY3410738
Time frame: Pre-dose up to 48 hours post-dose
PK: Maximum Observed Plasma Concentration (Cmax) of LY3410738
Time frame: Pre-dose up to 48 hours post-dose
PK: Time to Maximum Observed Plasma Concentration (Tmax) of LY3410738
Time frame: Pre-dose up to 48 hours post-dose
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 26 Dec 2023.
- 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.
Yingying Guo-Avrutin study director
Loxo Oncology, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3410738 in people with Healthy, run by Eli Lilly and Company at 2 sites 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 4 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 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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: Baseline through 53 days). 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 26 Dec 2023.