HealthyPhase 1NCT04991766
A Study of [¹⁴C]-LY3484356 in Healthy Female Participants
A Phase 1 study testing [¹⁴C]-LY3484356, LY3484356 and [¹⁴C]-LY3484356 (IV) 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 measure how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it. This study has two parts. It will involve a single dose of 14C radiolabeled LY3484356. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- [¹⁴C]-LY3484356, LY3484356 and [¹⁴C]-LY3484356 (IV)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2021to 2 Apr 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female participants of nonchildbearing potential. This includes females who are not pregnant, non-lactating and either: Infertile due to surgical sterilization or alternate medical cause/congenital or postmenopausal.
- Body mass index (BMI) within the range of 18.0 to 35.0 kilograms per meter squared (kg/m²)
Who cannot join
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorders
- Have evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
- Have known allergies to LY3484356, related compounds or any components of the formulation as appropriate, or history of significant atopy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Two-part Study of the Disposition and Absolute Bioavailability of [¹⁴C]-LY3484356 in Healthy Females of Non-Childbearing Potential
The main purpose of this study is to measure how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it. This study has two parts. It will involve a single dose of 14C radiolabeled LY3484356. This means that a radioactive substance C14 will be incorporated into the study drug, to investigate the study drug and its breakdown products, to find out how much of these pass from blood into urine, feces and expired air. The study will last about 4 weeks. Screening is required within 28 days prior to the start of the study and follow up is required approximately 7 days after discharge.
- Conditions
- Healthy
- Being tested
- [¹⁴C]-LY3484356, LY3484356, [¹⁴C]-LY3484356 (IV)
- Keywords
- Metabolism, Absolute Bioavailability, Disposition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[¹⁴C]-LY3484356Drug
Administered orally.
LY3484356Drug
Administered orally.
[¹⁴C]-LY3484356 (IV)Drug
Administered IV.
| Study group | Role | What they receive |
|---|---|---|
| [¹⁴C]-LY3484356 (Part 1) | Experimental | Participants received a single oral dose of 400 mg Carbon 14 labelled [¹⁴C]-LY3484356 following an overnight fast of at least 10 hours on Day 1. Receives: Drug: [¹⁴C]-LY3484356 |
| LY3484356 + [¹⁴C]-LY3484356 (Part 2) | Experimental | Participants received a single oral dose of 400 mg LY3484356 following an overnight fast of at least 10 hours on Day 1, followed 4 hours later by a single dose of less than 100 microgram (μg) [¹⁴C]-LY3484356 (actual ranged from 44.55 to 45.95 μg), as an intravenous (IV) infusion on day 1. Receives: Drug: LY3484356; Drug: [¹⁴C]-LY3484356 (IV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Pharmacokinetics (PK): Fecal Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
The percentage of the total radioactive dose administered that was excreted in feces = (amount of radioactive dose recovered in feces / total radioactive dose administered) * 100.
Measured: Predose, 24, 48, 72, 96, 120, 144, 168,192, 216, 240, 264, 288 and 312 hours post dose
Part 1: PK: Urinary Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
The percentage of the total radioactive dose administered that was excreted in urine = (amount of radioactive dose recovered in urine / total radioactive dose administered) * 100.
Measured: Predose, 24, 48 ,72, 96, 120, 144, 168, 192, 216, 240, 264, 288 and 312 hours post dose
Part 2: Pharmacokinetics (PK): Percent Absolute Bioavailability (F%) of LY3484356
PK: Bioavailability is defined as the percentage of a drug which enters the circulation when introduced into the body and so is able to have an active effect. Percent absolute bioavailability, calculated for plasma LY3484356 as "F %= [AUC (0-∞), LY3484356] × [Dose, [14C]-LY3484356] / [AUC (0-∞), [14C]-LY3484356] × [Dose, LY3484356] ×100%'' Higher percent indicates better absorption of drug into the body.
Measured: Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose
Secondary outcomes (11)
Part 1: PK: Total Radioactivity Recovered in Urine, Feces
Relative abundance was expressed and calculated as the percentage of administered dose excreted in urine/Feces=[(percentage of radioactivity in peak)/100]*(percentage of dose in sample).
Measured: Predose, 24, 48, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456 and 480 hours post dose
Part 1: Total Radioactivity Recovered in Expired Air
Radioactivity is expressed in becquerels (Bq), the International System of Unit (SI) representing one nuclear disintegration per second. For practical measurement, total radioactivity recovered in expired air is reported in disintegrations per minute (dpm). The conversion factor is: 1 Bq = 60 dpm.
Measured: predose, 8, and 24 hours postdose
Part 1: PK: Total Number of Metabolites of LY3484356 in Plasma, Urine and Feces
Total number of metabolites of LY3484356 is reported. The value is an absolute number without any measure of central tendency.
Measured: Plasma:Predose,24,48,72,96,120,144,168,192,216,240,264 and 288 hours(h) post dose;Urine:-12 to 0h Predose,0 to 6,6-12,and 12-24,48,72,96,120,144,168,192,216,240 and 264 hours post dose;Feces:Predose,24,48,72,96,120,144, 168,192,216,240 and 264 h post dose
Part 1: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for LY3484356 in Plasma
PK: AUC [0-∞] of LY3484356 in Plasma.
Measured: Part 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8,10, 12, 24, 48, 72, 96,120, 144, 168, 192, 216, 240, and 264 hours post-dose
Part 1: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for Total Radioactivity in Plasma
PK: AUC [0-∞] of Plasma Total Radioactivity.
Total radioactivity is reported as nanogram* hours equivalents per milliliter (ng*h Eq/mL).
Measured: Part 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8,10, 12, 24, 48, 72, 96,120, 144, 168, 192, 216, 240, and 264 hours post-dose
Part 1: PK: Maximum Concentration (Cmax) for LY3484356 in Plasma
PK: Cmax for LY3484356 in plasma.
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8,10, 12, 24, 48, 72, 96,120, 144, 168, 192, 216, 240, and 264 hours post-dose
Part 1: PK: Maximum Concentration (Cmax) for Total Radioactivity in Plasma
PK: Cmax for total radioactivity in plasma. The Cmax of total radioactivity are reported as nanogram equivalents per milliliter (ng Eq/mL).
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8,10, 12, 24, 48, 72, 96,120, 144, 168, 192, 216, 240, and 264 hours post-dose
Part 2: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for [¹⁴C]-LY3484356 and LY3484356 in Plasma
PK: AUC [0-∞] of Total Radioactivity.
Total radioactivity is reported as hours*nanogram equivalents per milliliter (h*ng Eq/mL).
Measured: Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose
Part 2: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for Total Radioactivity in Plasma
PK: AUC [0-∞] of Total Radioactivity in Plasma.
Measured: Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose
Part 2: PK: Maximum Concentration (Cmax) for [¹⁴C]-LY3484356 and LY3484356 in Plasma
PK: Cmax of LY3484356 and [¹⁴C]-LY3484356 in plasma.
Measured: Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose
Part 2: PK: Maximum Concentration (Cmax) for Total Radioactivity in Plasma
PK: Cmax of total radioactivity in plasma.
Measured: Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start13 Aug 2021
- Primary completion2 Apr 2022
- Study completion2 Apr 2022
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- 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
- NCT04991766
- Sponsor's protocol ID
- 18205
- Other IDs
- J2J-MC-JZLE
- Status last verified
- 15 Nov 2025
- First submitted
- 2 Aug 2021
- Last updated
- 5 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Two-part Study of the Disposition and Absolute Bioavailability of [¹⁴C]-LY3484356 in Healthy Females of Non-Childbearing Potential
- ClinicalTrials.gov ID
- NCT04991766
- Acronym / sponsor ID
- 18205
- Conditions
- Healthy
- Keywords
- Metabolism, Absolute Bioavailability, Disposition
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2021 (actual)
- Primary completion
- 2 Apr 2022 (actual)
- Study completion
- 2 Apr 2022 (actual)
- First posted
- 5 Aug 2021 (actual)
- Results
- Posted 5 Dec 2025
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 measure how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it. This study has two parts. It will involve a single dose of 14C radiolabeled LY3484356. This means that a radioactive substance C14 will be incorporated into the study drug, to investigate the study drug and its breakdown products, to find out how much of these pass from blood into urine, feces and expired air. The study will last about 4 weeks. Screening is required within 28 days prior to the start of the study and follow up is required approximately 7 days after discharge.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| [¹⁴C]-LY3484356 (Part 1) | Experimental | Drug: [¹⁴C]-LY3484356Participants received a single oral dose of 400 mg Carbon 14 labelled [¹⁴C]-LY3484356 following an overnight fast of at least 10 hours on Day 1. |
| LY3484356 + [¹⁴C]-LY3484356 (Part 2) | Experimental | Drug: LY3484356, Drug: [¹⁴C]-LY3484356 (IV)Participants received a single oral dose of 400 mg LY3484356 following an overnight fast of at least 10 hours on Day 1, followed 4 hours later by a single dose of less than 100 microgram (μg) [¹⁴C]-LY3484356 (actual ranged from 44.55 to 45.95 μg), as an intravenous (IV) infusion on day 1. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female participants of nonchildbearing potential. This includes females who are not pregnant, non-lactating and either: Infertile due to surgical sterilization or alternate medical cause/congenital or postmenopausal.
- Body mass index (BMI) within the range of 18.0 to 35.0 kilograms per meter squared (kg/m²)
Key exclusion criteria (3 listed)
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorders
- Have evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
- Have known allergies to LY3484356, related compounds or any components of the formulation as appropriate, or history of significant atopy
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 |
|---|---|---|
| [¹⁴C]-LY3484356Administered orally. | Drug | [¹⁴C]-LY3484356 (Part 1) |
| LY3484356Administered orally. | Drug | LY3484356 + [¹⁴C]-LY3484356 (Part 2) |
| [¹⁴C]-LY3484356 (IV)Administered IV. | Drug | LY3484356 + [¹⁴C]-LY3484356 (Part 2) |
Primary outcome
Part 1: Pharmacokinetics (PK): Fecal Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Time frame: Predose, 24, 48, 72, 96, 120, 144, 168,192, 216, 240, 264, 288 and 312 hours post dose
The percentage of the total radioactive dose administered that was excreted in feces = (amount of radioactive dose recovered in feces / total radioactive dose administered) * 100.
Part 1: PK: Urinary Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Time frame: Predose, 24, 48 ,72, 96, 120, 144, 168, 192, 216, 240, 264, 288 and 312 hours post dose
The percentage of the total radioactive dose administered that was excreted in urine = (amount of radioactive dose recovered in urine / total radioactive dose administered) * 100.
Part 2: Pharmacokinetics (PK): Percent Absolute Bioavailability (F%) of LY3484356
Time frame: Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose
PK: Bioavailability is defined as the percentage of a drug which enters the circulation when introduced into the body and so is able to have an active effect. Percent absolute bioavailability, calculated for plasma LY3484356 as "F %= [AUC (0-∞), LY3484356] × [Dose, [14C]-LY3484356] / [AUC (0-∞), [14C]-LY3484356] × [Dose, LY3484356] ×100%'' Higher percent indicates better absorption of drug into the body.
11 secondary outcomes
Part 1: PK: Total Radioactivity Recovered in Urine, Feces
Time frame: Predose, 24, 48, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456 and 480 hours post dose
Part 1: Total Radioactivity Recovered in Expired Air
Time frame: predose, 8, and 24 hours postdose
Part 1: PK: Total Number of Metabolites of LY3484356 in Plasma, Urine and Feces
Time frame: Plasma:Predose,24,48,72,96,120,144,168,192,216,240,264 and 288 hours(h) post dose;Urine:-12 to 0h Predose,0 to 6,6-12,and 12-24,48,72,96,120,144,168,192,216,240 and 264 hours post dose;Feces:Predose,24,48,72,96,120,144, 168,192,216,240 and 264 h post dose
Part 1: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for LY3484356 in Plasma
Time frame: Part 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8,10, 12, 24, 48, 72, 96,120, 144, 168, 192, 216, 240, and 264 hours post-dose
Part 1: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for Total Radioactivity in Plasma
Time frame: Part 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8,10, 12, 24, 48, 72, 96,120, 144, 168, 192, 216, 240, and 264 hours post-dose
Part 1: PK: Maximum Concentration (Cmax) for LY3484356 in Plasma
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8,10, 12, 24, 48, 72, 96,120, 144, 168, 192, 216, 240, and 264 hours post-dose
Part 1: PK: Maximum Concentration (Cmax) for Total Radioactivity in Plasma
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8,10, 12, 24, 48, 72, 96,120, 144, 168, 192, 216, 240, and 264 hours post-dose
Part 2: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for [¹⁴C]-LY3484356 and LY3484356 in Plasma
Time frame: Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose
Part 2: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for Total Radioactivity in Plasma
Time frame: Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose
Part 2: PK: Maximum Concentration (Cmax) for [¹⁴C]-LY3484356 and LY3484356 in Plasma
Time frame: Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose
Part 2: PK: Maximum Concentration (Cmax) for Total Radioactivity in Plasma
Time frame: Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 [¹⁴C]-LY3484356, LY3484356 and [¹⁴C]-LY3484356 (IV) 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 3 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 5 Dec 2025. 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. 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?
Yes. Results are posted in the registry (first posted 5 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Part 1: Pharmacokinetics (PK): Fecal Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered (time frame: Predose, 24, 48, 72, 96, 120, 144, 168,192, 216, 240, 264, 288 and 312 hours post dose). The study lists 3 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 5 Dec 2025.