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| ID | Type | Description | Link |
|---|---|---|---|
| I6F-MC-JJCF | Other Identifier | Eli Lilly and Company |
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This type of study is called a radiolabeled study. For this study, LY3039478 (study drug) has been specially prepared to contain radiolabeled carbon [¹⁴C]. [¹⁴C] is a naturally occurring radioactive form of the element carbon. This study will help determine how the drug appears in the blood, urine, and stool after it is administered by mouth to healthy people. Information about any side effects that may occur will also be collected. This study will last about 10 weeks for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiolabelled LY3039478 | Experimental | Single dose of radiolabelled LY3039478 administered orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3039478 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urinary and Fecal Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | To determine the disposition of radioactivity and LY3039478 in healthy participants following oral administration of a single dose 14C-labeled LY3039478. | Predose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, and 312 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY3039478 | The AUC[0-inf]) for plasma LY3039478 was evaluated by using a combination of the linear and logarithmic trapezoidal methods (linear-log trapezoidal rule). | Predose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose |
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Inclusion Criteria:
- Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m²), inclusive
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 Inc | Madison | Wisconsin | 53704 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 75 mg [14C2] LY3039478 | Participants received approximately 75 mg [14C2] LY3039478 containing approximately 100 μCi [14C2] LY3039478. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants who received the [14C2]-LY3039478 dose.
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| ID | Title | Description |
|---|---|---|
| BG000 | 75 mg [14C2] LY3039478 | Participants received approximately 75 mg [14C2] LY3039478 containing approximately 100 μCi [14C2] LY3039478. |
| 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 and Fecal Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | To determine the disposition of radioactivity and LY3039478 in healthy participants following oral administration of a single dose 14C-labeled LY3039478. | All participants who received the [14C2]-LY3039478 dose. | Posted | Mean | Standard Deviation | percentage of administered radioactivity | Predose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, and 312 hours postdose |
|
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All the participants who received the [14C2]-LY3039478 dose.
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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 | 75 mg [14C2] LY3039478 | All the participants received approximately 75 mg [14C2] LY3039478 containing approximately 100 μCi [14C2] LY3039478, with the exception of participant 01005 who received a lower than expected dose (84.5249 µCi, rather than the target dose of 100 µCi). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| C000654634 | crenigacestat |
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| Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Total Plasma Radioactivity | The AUC[0-inf]) for total plasma radioactivity was evaluated by using a combination of the linear and logarithmic trapezoidal methods (linear-log trapezoidal rule). | Predose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose |
| Pharmacokinetics: Maximum Observed Concentration (Cmax) of LY3039478 | The Cmax of LY3039478 was evaluated. | Predose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose |
| Pharmacokinetics: Maximum Observed Concentration (Cmax) of Total Plasma Radioactivity | Cmax of total plasma radioactivity was evaluated. | Predose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose |
| Total Number of Metabolites of LY3039478 in Plasma, Urine and Feces | Following oral administration, radio high performance liquid chromatography (HPLC) and liquid chromatography-mass spectrometry (LC-MS) profiles were obtained from analysis of plasma, urine and feces. | Predose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose. |
| years |
|
| Sex: Female, Male | 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 |
|
|
| Secondary | Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY3039478 | The AUC[0-inf]) for plasma LY3039478 was evaluated by using a combination of the linear and logarithmic trapezoidal methods (linear-log trapezoidal rule). | All the participants who received [14C2]-LY3039478 dose and had evaluable data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour/milliliter (ng*h/mL) | Predose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose |
|
|
|
| Secondary | Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Total Plasma Radioactivity | The AUC[0-inf]) for total plasma radioactivity was evaluated by using a combination of the linear and logarithmic trapezoidal methods (linear-log trapezoidal rule). | All the participants who received [14C2]-LY3039478 dose and had evaluable data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng quivalents*hour/gram (ng equiv.h/g) | Predose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose |
|
|
|
| Secondary | Pharmacokinetics: Maximum Observed Concentration (Cmax) of LY3039478 | The Cmax of LY3039478 was evaluated. | All the participants who received [14C2]-LY3039478 dose and had evaluable data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms/milliliter (ng/ml) | Predose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose |
|
|
|
| Secondary | Pharmacokinetics: Maximum Observed Concentration (Cmax) of Total Plasma Radioactivity | Cmax of total plasma radioactivity was evaluated. | All participants who received [14C2]-LY3039478 dose and had evaluable data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms equivalents/gram (ng equiv/g) | Predose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose |
|
|
|
| Secondary | Total Number of Metabolites of LY3039478 in Plasma, Urine and Feces | Following oral administration, radio high performance liquid chromatography (HPLC) and liquid chromatography-mass spectrometry (LC-MS) profiles were obtained from analysis of plasma, urine and feces. | All participants who received [14C2]-LY3039478 dose. For the feces profiling, only one participant had quantifiable radioactive dose recovered in feces adequate for metabolite profiling and was therefore eligible for analysis. | Posted | Number | Metabolites | Predose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose. |
|
|
|
| 0 |
| 6 |
| 6 |
| 6 |
| Constipation | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Chills | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Feeling hot | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Scratch | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
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| Number of Metabolites of LY3039478 in Feces |
|
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