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| ID | Type | Description | Link |
|---|---|---|---|
| J2A-MC-GZGF | 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 eliminate it. This study will involve a single dose of ¹⁴C radiolabelled LY3502970. This means that a radioactive substance will be incorporated into the study drug. The purposes are to investigate the study drug and its breakdown products and to find out how much of these pass from blood into urine and feces. The study will last up to 8 weeks (maximum).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3mg [¹⁴C]-LY3502970 | Experimental | Participants received a single oral dose of 3 milligrams (mg) of carbon-14-labeled [¹⁴C]-LY3502970, containing approximately 200 microcuries (µCi) of radioactivity on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [¹⁴C]-LY3502970 | Drug | Administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Feces Excretion of LY3502970 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Feces excretion of LY3502970 radioactivity over time expressed as a percentage of the total radioactive dose administered. Feces samples collected from 0 hour (h), where 0h = time of dose administration, through 384h postdose were used to assess this outcome. | 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, and 384 hours (h) postdose |
| Urinary Excretion of LY3502970 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Urinary excretion of LY3502970 radioactivity over time expressed as a percentage of the total radioactive dose administered. Urine samples collected from 0 hour (h), where 0h = time of dose administration, through 384h postdose were used to assess this outcome. | 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, and 384 hours (h) postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve t, Where t is the Last Time Point With a Measurable Concentration (AUC0- Tlast) of Plasma LY3502970 | PK: AUC0-tlast of plasma LY3502970 | Predose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384 hours (h) postdose |
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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 |
|---|---|---|---|---|---|---|
| Covance Clinical Research | Leeds | LS2 9LH | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | 3mg [¹⁴C]-LY3502970 | Participants received a single oral dose of 3 milligrams (mg) of carbon-14-labeled [¹⁴C]-LY3502970, containing approximately 200 microcuries (µCi) of radioactivity on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 3mg [¹⁴C]-LY3502970 | Participants received a single oral dose of 3mg of carbon-14-labeled [¹⁴C]-LY3502970, containing approximately 200 µCi of radioactivity on Day 1. |
| 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 | Feces Excretion of LY3502970 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Feces excretion of LY3502970 radioactivity over time expressed as a percentage of the total radioactive dose administered. Feces samples collected from 0 hour (h), where 0h = time of dose administration, through 384h postdose were used to assess this outcome. | All enrolled participants who received at least one dose of study drug and had evaluable data for this outcome. | Posted | Mean | Standard Deviation | percentage of the total radioactive dose | 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, and 384 hours (h) postdose |
|
Baseline up to Day 26
All enrolled participants who received at least one dose of study drug.
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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 | 3mg [¹⁴C]-LY3502970 | Participants received a single oral dose of 3mg of carbon-14-labeled [¹⁴C]-LY3502970, containing approximately 200 µCi of radioactivity on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 23.0 | 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 | May 18, 2021 | Apr 16, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 28, 2020 | Apr 16, 2026 | SAP_001.pdf |
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| PK: Area Under the Concentration Versus Time Curve t, Where t is the Last Time Point With a Measurable Concentration ((AUC0- Tlast) of Total Radioactivity in Plasma and Whole Blood |
PK: AUC0-tlast of total radioactivity in plasma and whole blood |
| Predose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384 hours (h) postdose |
| PK: Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC (0-∞)] of Plasma LY3502970 | PK: AUC(0-∞) of plasma LY3502970 | Predose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384 hours (h) postdose |
| PK: Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC (0-∞)] of Total Radioactivity in Plasma and Whole Blood | PK: AUC(0-∞) of total radioactivity in plasma and whole blood | Predose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384 hours (h) postdose |
| PK: Maximum Concentration (Cmax) of Plasma LY3502970 | PK: Cmax of plasma LY3502970 | Predose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384 hours (h) postdose |
| PK: Maximum Concentration (Cmax) of Total Radioactivity in Plasma and Whole Blood | PK: Cmax of total radioactivity in plasma and whole blood | Predose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384 hours (h) postdose |
| Total Number of Metabolites of LY3502970 in Plasma, Urine and Feces |
| Plasma: 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 h postdose; Urine: -12 to 0, 0-6, 6-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216, 216-240, 240-264, 264-288, 288-312, 312-336, 336-360, 360-384h postdose |
| 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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| Primary | Urinary Excretion of LY3502970 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Urinary excretion of LY3502970 radioactivity over time expressed as a percentage of the total radioactive dose administered. Urine samples collected from 0 hour (h), where 0h = time of dose administration, through 384h postdose were used to assess this outcome. | All enrolled participants who received at least one dose of study drug and had evaluable data for this outcome. | Posted | Mean | Standard Deviation | percentage of the total radioactive dose | 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, and 384 hours (h) postdose |
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| Secondary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve t, Where t is the Last Time Point With a Measurable Concentration (AUC0- Tlast) of Plasma LY3502970 | PK: AUC0-tlast of plasma LY3502970 | All enrolled participants who received at least one dose of study drug and had evaluable PK data for this outcome. Participants were excluded from the analysis if they experienced vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax). | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter(ng*h/mL) | Predose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384 hours (h) postdose |
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| Secondary | PK: Area Under the Concentration Versus Time Curve t, Where t is the Last Time Point With a Measurable Concentration ((AUC0- Tlast) of Total Radioactivity in Plasma and Whole Blood | PK: AUC0-tlast of total radioactivity in plasma and whole blood | All enrolled participants who received at least one dose of study drug and had evaluable PK data for this outcome. Participants were excluded from the analysis if they experienced vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax). | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram equivalents*hour per milliliter | Predose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384 hours (h) postdose |
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|
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| Secondary | PK: Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC (0-∞)] of Plasma LY3502970 | PK: AUC(0-∞) of plasma LY3502970 | All enrolled participants who received at least one dose of study drug and had evaluable PK data for this outcome. Participants were excluded from the analysis if they experienced vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax). | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter(ng*h/mL) | Predose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384 hours (h) postdose |
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|
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| Secondary | PK: Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC (0-∞)] of Total Radioactivity in Plasma and Whole Blood | PK: AUC(0-∞) of total radioactivity in plasma and whole blood | All enrolled participants who received at least one dose of study drug and had evaluable PK data for this outcome. Participants were excluded from the analysis if they experienced vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax). | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram equivalents*hour per milliliter | Predose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384 hours (h) postdose |
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|
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| Secondary | PK: Maximum Concentration (Cmax) of Plasma LY3502970 | PK: Cmax of plasma LY3502970 | All enrolled participants who received at least one dose of study drug and had evaluable PK data for this outcome. Participants were excluded from the analysis if they experienced vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax). | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter(ng/mL) | Predose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384 hours (h) postdose |
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|
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| Secondary | PK: Maximum Concentration (Cmax) of Total Radioactivity in Plasma and Whole Blood | PK: Cmax of total radioactivity in plasma and whole blood | All enrolled participants who received at least one dose of study drug and had evaluable PK data for this outcome. Participants were excluded from the analysis if they experienced vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax). | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram equivalents per milliliter | Predose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384 hours (h) postdose |
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| Secondary | Total Number of Metabolites of LY3502970 in Plasma, Urine and Feces |
| All enrolled participants who received at least one dose of study drug and had evaluable data for this outcome. | Posted | Number | number of metabolites | Plasma: 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 h postdose; Urine: -12 to 0, 0-6, 6-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216, 216-240, 240-264, 264-288, 288-312, 312-336, 336-360, 360-384h postdose |
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|
| 0 |
| 6 |
| 0 |
| 6 |
| 6 |
| 6 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Vessel puncture site bruise | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Head discomfort | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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