HealthyPhase 1NCT06085482
A Phase I Study of LY3502970 in Healthy Participants
A Phase 1 study testing LY3502970 and [14C]-LY3502970 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 how much of the study drug (LY3502970) and the radioactive substance 14C incorporated LY3502970 gets into the bloodstream, how its broken down, and how long it takes the body to get rid of it. The study will last up to approximately 9 weeks for each participant. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY3502970 and [14C]-LY3502970
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2023to 5 Jan 2024
- Phase
- Phase 1
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are overtly healthy as determined by medical evaluation
- Participants with body weight of 45 kilograms (kg) or more and body mass index within the range 18.5 to 35.0 kilograms per meter squared (kg/m²), inclusive
- Males who agree to use highly effective or effective methods of contraception and women not of childbearing potential may participate in this study
Who cannot join
- Participants who have known allergies to LY3502970, related compounds, or any components of the formulation
- Women who are lactating and women of child bearing potential (WOCBP) are excluded from the study
- Participants who regularly use known drugs of abuse or show positive findings on drug screen
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Inc
Madison, Wisconsin, 53704
About this study
Official title: A Single-Group, Open-Label, Single-Period, Phase 1 Study to Determine the Absolute Bioavailability of LY3502970 in Healthy Participants
The main purpose of this study is to evaluate how much of the study drug (LY3502970) and the radioactive substance 14C incorporated LY3502970 gets into the bloodstream, how its broken down, and how long it takes the body to get rid of it. The study will last up to approximately 9 weeks for each participant.
- Conditions
- Healthy
- Being tested
- LY3502970, [14C]-LY3502970
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3502970Drug
Administered orally
[14C]-LY3502970Drug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| LY3502970 + [14C]-LY3502970 | Experimental | Participants received a single oral dose of 1 milligram (mg) LY3502970 followed six hours later by an intravenous (IV) dose of approximately 21 microgram (μg) of LY3502970 radiolabeled with carbon-14 ([14C]-LY3502970) containing approximately 800 nanocurie (nCi) radioactivity. Receives: Drug: LY3502970; Drug: [14C]-LY3502970 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Absolute Bioavailability of LY3502970
Absolute bioavailability of LY3502970, expressed in percentage, was estimated using the AUC(0-∞) values from each individual participant based on IV dosed [14C]-LY3502970 compared to oral dosed LY3502970, using formula: [AUC0-∞(oral) x Dose (IV) divided by AUC0-∞(IV) x Dose (oral)] x100. The sampling time points from pre-oral dose through 186 hours post-IV dose were used to assess this outcome.
Measured: Pre-oral dose, 0.5, 1, 2, 4, 6, 6.5, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours post-oral dose; 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138, 162, 186 hours post-IV dose.
Secondary outcomes (6)
PK: Area Under the Curve Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of Total Radioactivity in Plasma
PK: AUC [0-∞] of Total Radioactivity in Plasma.
Measured: 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138 hours post-IV dose
PK: AUC [0-∞] of [14C]-LY3502970 in Plasma
PK: AUC [0-∞] of [14C]-LY3502970 in Plasma.
Measured: 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138, 162, 186 hours post-IV dose
PK: AUC [0-∞] of LY3502970 in Plasma
PK: AUC [0-∞] of LY3502970 in Plasma.
Measured: Pre-oral dose, 0.5, 1, 2, 4, 6, 6.5, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours post-oral dose
PK: Maximum Concentration (Cmax) of Total Radioactivity in Plasma
PK: Cmax of Total Radioactivity in Plasma.
Measured: 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138 hours post-IV dose
PK: Cmax of [14C]-LY3502970 in Plasma
PK: Cmax of [14C]-LY3502970 in Plasma.
Measured: 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138, 162, 186 hours post-IV dose
PK: Cmax of LY3502970 in Plasma
PK: Cmax of LY3502970 in Plasma.
Measured: Pre-oral dose, 0.5, 1, 2, 4, 6, 6.5, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours post-oral dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start19 Oct 2023
- Primary completion5 Jan 2024
- Study completion5 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT06085482
- Sponsor's protocol ID
- 18596
- Other IDs
- J2A-MC-GZGO
- Status last verified
- Apr 2026
- First submitted
- 10 Oct 2023
- Last updated
- 27 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No