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| ID | Type | Description | Link |
|---|---|---|---|
| H8Y-MC-HBCU | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to assess the extent and rate of absorption of LY2140023 in healthy participants. The study has two periods. In Treatment Period 1, participants will receive a single oral dose of 80 milligrams (mg) LY2140023 followed by a 2-hour intravenous (IV) infusion of approximately 100 micrograms (µg) LY2140023 containing approximately 100 nanocuries (nCi) [14C]-LY2140023. In Treatment Period 2, participants will receive an oral dose of 80 mg LY2140023 followed by a 2-hour IV infusion of approximately 100 µg LY404039 containing approximately 100 nCi [14C]-LY404039. There will be at least a 3-day washout between doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2140023 + [14C]-LY2140023 | Experimental | Treatment Period 1: On Day 1, a single oral dose of 80 milligrams (mg) LY2140023 (parent compound) followed by a single 2-hour intravenous (IV) infusion of approximately 100 micrograms (µg) LY2140023 containing approximately 100 nanocuries (nCi) [14C]-LY2140023. |
|
| LY2140023 + [14C]-LY404039 | Experimental | Treatment Period 2: On Day 1, a single oral dose of 80 mg LY2140023 (parent compound) followed by a single 2-hour IV infusion of approximately 100 µg LY404039 containing approximately 100 nCi [14C]-LY404039 (active metabolite). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2140023 | Drug | Administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY2140023 and LY404039 in Treatment Period 1 | Exposure of LY2140023 (parent compound), LY404039 (active metabolite), 14C-radiolabeled LY2140023, and 14C-radiolabeled LY404039 in terms of Area Under the Concentration Versus Time Curve from time 0 extrapolated to infinity (AUC[0-inf]) is summarized for participants in Treatment Period 1. | Predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16 and 24 hours postdose |
| Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY2140023 and LY404039 in Treatment Period 2 | Exposure of LY2140023 (parent compound), LY404039 (active metabolite), and 14C-radiolabeled LY404039 in terms of Area Under the Concentration Versus Time Curve from time 0 extrapolated to infinity (AUC[0-inf]) is summarized for participants in Treatment Period 2. | Predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16 and 24 hours postdose |
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Inclusion Criteria:
Exclusion Criteria:
Are currently enrolled in or have completed or discontinued within the last 90 days from a clinical trial involving an investigational product other than the investigational product used in this study; or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Have participated in any clinical trial involving a radiolabeled investigational product or been exposed to radiolabeled substances (for treatment or diagnosis) within the last 12 months
Have known allergies to LY2140023 or LY404039, related compounds, or any components of the formulation
Are persons who have previously withdrawn from this study or any other study investigating LY2140023 after receiving at least 1 dose of LY2140023
Show evidence or any history of significant active neuropsychiatric disease (for example, manic depressive illness, schizophrenia, depression)
Have increased risk of seizures based on a history of:
Show evidence of active renal disease (for example, diabetic renal disease, polycystic kidney disease) or creatinine clearance less than 80 milliliters/minute (mL/min) as determined by the Cockroft Gault formula
Show evidence or any history of known substance dependence or abuse at any time (according to Diagnostic and Statistical Manual of Mental Disorders [DSM-IV] diagnosis), or regularly use known drugs of abuse and/or show positive findings on urinary drug screening
Have a clinically significant abnormality in the neurological examination
Participants judged prior to randomization to be at suicidal risk by the investigator
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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 |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Leeds | West Yorkshire | LS2 9LH |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral 80 mg LY2140023 on Two Separate Occasions | Participants received a single oral dose of 80 milligrams (mg) LY2140023 (parent compound) on 2 separate occasions. In Treatment Period 1, a single oral dose of 80 mg LY2140023 followed by a single 2-hour intravenous (IV) infusion of approximately 100 micrograms (µg) LY2140023 containing approximately 100 nanocuries (nCi) [14C]-LY2140023. In Treatment Period 2, a single oral dose of 80 mg LY2140023 followed by a single 2-hour IV infusion of approximately 100 µg LY404039 (active metabolite) containing approximately 100 nCi [14C]-LY404039. There was a washout period of at least 3 days between Treatment Period 1 and Treatment Period 2. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
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| Washout Period (at Least 3 Days) |
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| Treatment Period 2 |
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All participants who received at last 1 dose of LY2140023.
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral 80 mg LY2140023 on Two Separate Occasions | Participants received a single oral dose of 80 mg LY2140023 (parent compound) on 2 separate occasions. In Treatment Period 1, a single oral dose of 80 mg LY2140023 followed by a single 2-hour IV infusion of approximately 100 µg LY2140023 containing approximately 100 nCi [14C]-LY2140023. In Treatment Period 2, a single oral dose of 80 mg LY2140023 followed by a single 2-hour IV infusion of approximately 100 µg LY404039 (active metabolite) containing approximately 100 nCi [14C]-LY404039. There was a washout period of at least 3 days between Treatment Period 1 and Treatment Period 2. |
| 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 | Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY2140023 and LY404039 in Treatment Period 1 | Exposure of LY2140023 (parent compound), LY404039 (active metabolite), 14C-radiolabeled LY2140023, and 14C-radiolabeled LY404039 in terms of Area Under the Concentration Versus Time Curve from time 0 extrapolated to infinity (AUC[0-inf]) is summarized for participants in Treatment Period 1. | Participants who received oral LY2140023 with IV [14C]-LY2140023 and had evaluable pharmacokinetic (PK) concentration data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms times hours per milliliter | Predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16 and 24 hours postdose |
|
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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 | Oral 80 mg LY2140023 and IV LY2140023/[14C]-LY2140023 | Treatment Period 1: On Day 1, a single oral dose of 80 mg LY2140023 (parent compound) followed by a single 2-hour IV infusion of approximately 100 µg LY2140023 containing approximately 100 nCi [14C]-LY2140023. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Toothache | Gastrointestinal disorders | MedDRA 14.1 | 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 |
|---|---|
| C534551 | LY 2140023 |
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| 14C-LY2140023 | Drug | Administered IV. |
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| 14C-LY404039 | Drug | Administered IV. |
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| United Kingdom |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY2140023 and LY404039 in Treatment Period 2 | Exposure of LY2140023 (parent compound), LY404039 (active metabolite), and 14C-radiolabeled LY404039 in terms of Area Under the Concentration Versus Time Curve from time 0 extrapolated to infinity (AUC[0-inf]) is summarized for participants in Treatment Period 2. | Participants who received oral LY2140023 with IV [14C]-LY404039 and had evaluable PK concentration data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms times hours per milliliter | Predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16 and 24 hours postdose |
|
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|
| 0 |
| 18 |
| 8 |
| 18 |
| EG001 | Oral 80 mg LY2140023 and IV LY404039/[14C]-LY404039 | Treatment Period 2: On Day 1, a single oral dose of 80 mg LY2140023 (parent compound) followed by a single 2-hour IV infusion of approximately 100 µg LY404039 (active metabolite) containing approximately 100 nCi [14C]-LY404039. | 0 | 17 | 10 | 17 |
| Application site erythema | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Catheter site erythema | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Herpes simplex | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Title | Measurements |
|---|---|
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