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| ID | Type | Description | Link |
|---|---|---|---|
| I8F-MC-GPHX | Other Identifier | Eli Lilly and Company | |
| 2019-003664-44 | EudraCT Number |
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The purpose of this study is to look at how much tirzepatide gets into the bloodstream and how long the body takes to get rid of it. This study will involve a single dose of 14C radiolabelled tirzepatide. This means that a radioactive tracer substance, C14, will be incorporated into the study drug to investigate the study drug and its breakdown products and to find out how much of these pass from blood into urine, feces and expired air.
Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be approximately 15 weeks, including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 14C Tirzepatide | Experimental | A single dose of [14C]-tirzepatide administered subcutaneously (SC). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 14C Tirzepatide | Drug | Administered SC. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered | Urinary Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered. | Pre-dose and up to 63 days post-dose |
| Fecal Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered | Fecal Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered. | Pre-dose and up to 63 days post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Metabolites | Total Number of Metabolites. | Pre-dose and up to 63 days post-dose |
| Total Radioactivity Recovered in Urine, Feces, and Expired Air (if Applicable) | Total Radioactivity Recovered in Urine, Feces, and Expired Air (if Applicable). |
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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 Ltd | Leeds | West Yorkshire | LS2 9LH | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | [14C]-Tirzepatide | Participants received single dose of approximately 4.1 milligrams (mg) tirzepatide containing approximately 100 microcurie (μCi) of [14C]- tirzepatide administered as a subcutaneous injection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | [14C]-Tirzepatide | Participants received single dose of approximately 4.1 mg tirzepatide containing approximately 100 μCi of [14C]- tirzepatide administered as a subcutaneous injection. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Urinary Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered | Urinary Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered. | All randomized participants who received at least one dose of study drug. | Posted | Mean | Standard Deviation | Percentage of the total radioactive dose | Pre-dose and up to 63 days post-dose |
|
Up To Day 64
All randomized participants
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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 | [14C]-Tirzepatide | Participants received single dose of approximately 4.1 mg tirzepatide containing approximately 100 μCi of [14C]- tirzepatide administered as a subcutaneous injection. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac 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 19, 2020 | May 18, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 14, 2020 | May 18, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000098860 | Tirzepatide |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
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| Pre-dose and up to 63 days post-dose |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC[0-∞]) of Tirzepatide | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC[0-∞]) of tirzepatide. | Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose |
| PK: Maximum Concentration (Cmax) of Tirzepatide | PK: Maximum Concentration (Cmax) of tirzepatide. | Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC[0-∞]) of Total Radioactivity | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC[0-∞]) of Total Radioactivity. Total radioactivity is reported as hours*nanogram equivalents per milliliter (h*ng Eq/mL). | Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose |
| PK: Maximum Concentration (Cmax) of Total Radioactivity | PK: Cmax of total radioactivity in plasma and whole blood. The Cmax of total radioactivity in plasma and whole blood are reported as nanogram equivalents per milliliter (ng Eq/mL). | Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Fecal Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered | Fecal Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered. | All randomized participants who received at least one dose of study drug. | Posted | Mean | Standard Deviation | Percentage of the total radioactive dose | Pre-dose and up to 63 days post-dose |
|
|
|
| Secondary | Total Number of Metabolites | Total Number of Metabolites. | All randomized participants who received at least one dose of study drug. | Posted | Number | metabolites | Pre-dose and up to 63 days post-dose |
|
|
|
| Secondary | Total Radioactivity Recovered in Urine, Feces, and Expired Air (if Applicable) | Total Radioactivity Recovered in Urine, Feces, and Expired Air (if Applicable). | All randomized participants who received at least one dose of study drug. | Posted | Mean | Standard Deviation | Percentage of the total radioactive dose | Pre-dose and up to 63 days post-dose |
|
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC[0-∞]) of Tirzepatide | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC[0-∞]) of tirzepatide. | All randomized participants who received at least one dose of study drug and had evaluable PK data of tirzepatide. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*h/mL) | Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose |
|
|
|
| Secondary | PK: Maximum Concentration (Cmax) of Tirzepatide | PK: Maximum Concentration (Cmax) of tirzepatide. | All randomized participants who received at least one dose of study drug and had evaluable PK data of tirzepatide. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose |
|
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC[0-∞]) of Total Radioactivity | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC[0-∞]) of Total Radioactivity. Total radioactivity is reported as hours*nanogram equivalents per milliliter (h*ng Eq/mL). | All randomized participants who received at least one dose and had evaluable PK data for total radioactivity. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng Eq/mL | Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose |
|
|
|
| Secondary | PK: Maximum Concentration (Cmax) of Total Radioactivity | PK: Cmax of total radioactivity in plasma and whole blood. The Cmax of total radioactivity in plasma and whole blood are reported as nanogram equivalents per milliliter (ng Eq/mL). | All randomized participants who received at least one dose and had evaluable PK data for total radioactivity. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng Eq/mL | Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 6 |
| 6 |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Feeling of body temperature change | 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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| Presyncope | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
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| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |
|