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| ID | Type | Description | Link |
|---|---|---|---|
| J2J-MC-JZLE | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [¹⁴C]-LY3484356 | Drug | Administered orally. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Predose, 24, 48, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456 and 480 hours post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LabCorp CRU, Inc. | Madison | Wisconsin | 53704 | United States |
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This is a two-part study. Participants in Part 1 did not participate in Part 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: [¹⁴C]-LY3484356 | Participants received a single oral dose of 400 milligram (mg) Carbon 14 labelled [¹⁴C]-LY3484356 following an overnight fast of at least 10 hours on Day 1. |
| FG001 | Part 2: LY3484356 + [¹⁴C] LY3484356 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All enrolled participants who received at least 1 dose of study drug (LY3484356 or [¹⁴C]-LY3484356).
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: [¹⁴C]-LY3484356 | 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. |
| BG001 | Part 2: LY3484356 + [¹⁴C] LY3484356 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All enrolled participants who received at least 1 dose of [¹⁴C]-LY3484356 and had evaluable PK data for this outcome. | Posted | Mean | Full Range | percentage of the total radioactive dose | Predose, 24, 48, 72, 96, 120, 144, 168,192, 216, 240, 264, 288 and 312 hours post dose |
|
Part 1: Baseline Up to Day 29, Part 2: Baseline Up to Day 16
All enrolled participants who received at least 1 dose of LY3484356 or [14C]-LY3484356, whether or not they completed all protocol requirements.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1: [¹⁴C]-LY3484356 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 5, 2021 | Jan 2, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 21, 2021 | Jan 2, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000719756 | Imlunestrant |
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| LY3484356 |
| Drug |
Administered orally. |
|
| [¹⁴C]-LY3484356 (IV) | Drug | Administered IV. |
|
| 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. | 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. | 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. | 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). | 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. | 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). | 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). | 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. | 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. | 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. | 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 |
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 μg [¹⁴C]-LY3484356 (actual ranged from 44.55 to 45.95 μg), as an IV infusion on day 1.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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. | All enrolled participants who received at least 1 dose of [¹⁴C]-LY3484356 and had evaluable PK data for this outcome. | Posted | Mean | Full Range | percentage of the total radioactive dose | Predose, 24, 48 ,72, 96, 120, 144, 168, 192, 216, 240, 264, 288 and 312 hours post dose |
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| Primary | 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. | All enrolled participants who received at least 1 dose of LY3484356 + [¹⁴C]-LY3484356 and have evaluable PK data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | percent absolute bioavailability | 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 |
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| Secondary | 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). | All enrolled participants who received at least 1 dose of [¹⁴C]-LY3484356 and had evaluable PK data for this outcome. | Posted | Mean | Full Range | percentage of recovered radioactivity | Predose, 24, 48, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456 and 480 hours post dose |
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| Secondary | 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. | All enrolled participants who received at least 1 dose of [¹⁴C]-LY3484356 and had evaluable PK data for this outcome. | Posted | Number | disintegrations per minute | predose, 8, and 24 hours postdose |
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| Secondary | 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. | All enrolled participants who received at least 1 dose of [¹⁴C]-LY3484356 and had evaluable PK data for this outcome. | Posted | Number | number of metabolites | 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 |
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| Secondary | 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. | All enrolled participants who received at least 1 dose of [¹⁴C]-LY3484356 and had evaluable PK data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | 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 |
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| Secondary | 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). | All enrolled participants who received at least 1 dose of [¹⁴C]-LY3484356 and had evaluable PK data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h Eq/mL | 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 |
|
|
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| Secondary | Part 1: PK: Maximum Concentration (Cmax) for LY3484356 in Plasma | PK: Cmax for LY3484356 in plasma. | All enrolled participants who received at least 1 dose of [¹⁴C]-LY3484356 and had evaluable PK data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | 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 |
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| Secondary | 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). | All enrolled participants who received at least 1 dose of [¹⁴C]-LY3484356 and had evaluable PK data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng Eq/mL | 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 |
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| Secondary | 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). | All enrolled participants who received at least 1 dose of LY3484356 or [¹⁴C]-LY3484356 and have evaluable PK data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | 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 |
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| Secondary | 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. | All enrolled participants who received at least 1 dose of LY3484356 or [¹⁴C]-LY3484356 and have evaluable PK data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h Eq/mL | 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 |
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| Secondary | Part 2: PK: Maximum Concentration (Cmax) for [¹⁴C]-LY3484356 and LY3484356 in Plasma | PK: Cmax of LY3484356 and [¹⁴C]-LY3484356 in plasma. | All enrolled participants who received at least 1 dose of LY3484356 or [¹⁴C]-LY3484356 and have evaluable PK data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 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 |
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| Secondary | Part 2: PK: Maximum Concentration (Cmax) for Total Radioactivity in Plasma | PK: Cmax of total radioactivity in plasma. | All enrolled participants who received at least 1 dose of LY3484356 or [¹⁴C]-LY3484356 and have evaluable PK data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng Eq/mL | 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 |
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| 0 |
| 8 |
| 0 |
| 8 |
| 8 |
| 8 |
| EG001 | Part 2: LY3484356 + [¹⁴C]-LY3484356 | 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 μg [¹⁴C]-LY3484356 (actual ranged from 44.55 to 45.95 μg), as an IV infusion on day 1. | 0 | 8 | 0 | 8 | 3 | 8 |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Infusion site pain | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Pyuria | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Title | Measurements |
|---|
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