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| ID | Type | Description | Link |
|---|---|---|---|
| I2R-MC-BIDH | Other Identifier | Eli Lilly and Company |
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This study looks at the amount of LY2605541 in the body after it is injected under the skin. The study has 3 periods, each lasting 10 days. Each participant will receive one injection in each period. At least 14 days will pass between each injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2605541 - Source 1 | Experimental | Each healthy participant will receive a single subcutaneous (SC) injection of 0.5 units per kilogram (U/kg) of LY2605541 on Day 1 of 1 of 3 treatment periods |
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| LY2605541 - Source 2 | Experimental | Each healthy participant will receive single SC injection of 0.5 U/kg of LY2605541 on Day 1 of 1of 3 treatment periods |
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| LY2605541 - Source 3 | Experimental | Each healthy participant will receive single SC injection of 0.5 U/kg of LY2605541 on Day 1 of 1 of 3 treatment periods |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2605541 | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area Under the Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY2605541 | LY2605541 exposure in terms of AUC from time 0 extrapolated to infinity (AUC[0-inf]) is summarized for each PEG source (LY1, LY2, or LY3). | Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post dose in each period |
| Pharmacokinetics: Maximum Concentration (Cmax) of LY2605541 | The maximum observed drug concentration (Cmax) of LY2605541 is summarized for each PEG source (LY1, LY2, or LY3). | Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post dose in each period |
| Measure | Description | Time Frame |
|---|---|---|
| Glucodynamics: Maximum Glucose Infusion Rate (Rmax) | The maximum observed glucose infusion rate following LY2605541 injection is summarized for each PEG source (LY1, LY2, or LY3). | Predose and up to 24 hours post dose in each period |
| Glucodynamics: Total Amount of Glucose Infused (Gtot) |
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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 |
|---|---|---|---|---|---|---|
| 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. | Dallas | Texas | 75247 |
LY2605541 was manufactured using the 3 different polyethylene glycol (PEG) sources (referred to as Source 1 [LY1], Source 2 [LY2], and Source 3 [LY3]). Participants were randomized to 1 of 6 treatment sequences and received a single injection of LY1, LY2, or LY3 on Day 1 of each of 3 treatment periods according to their assigned treatment sequence.
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| ID | Title | Description |
|---|---|---|
| FG000 | LY3/LY2/LY1 | A single, subcutaneous (SC) injection of 0.5 units per kilogram (U/kg) LY2605541 from Source 3 on Day 1 of Period 1; from Source 2 on Day 1 of Period 2; and from Source 1 on Day 1 of Period 3. There was a washout period of at least 14 days between injections. Each participant received up to 3 injections. |
| FG001 | LY2/LY1/LY3 | A single, SC injection of 0.5 U/kg LY2605541 from Source 2 on Day 1 of Period 1; from Source 1 on Day 1 of Period 2; and from Source 3 on Day 1 of Period 3. There was a washout period of at least 14 days between injections. Each participant received up to 3 injections. |
| FG002 | LY1/LY2/LY3 | A single, SC injection of 0.5 U/kg LY2605541 from Source 1 on Day 1 of Period 1; from Source 2 on Day 1 of Period 2; and from Source 3 on Day 1 of Period 3. There was a washout period of at least 14 days between injections. Each participant received up to 3 injections. |
| FG003 | LY1/LY3/LY2 | A single, SC injection of 0.5 U/kg LY2605541 from Source 1 on Day 1 of Period 1; from Source 3 on Day 1 of Period 2; and from Source 2 on Day 1 of Period 3. There was a washout period of at least 14 days between injections. Each participant received up to 3 injections. |
| FG004 | LY3/LY1/LY2 | A single, SC injection of 0.5 U/kg LY2605541 from Source 3 on Day 1 of Period 1; from Source 1 on Day 1 of Period 2; and from Source 2 on Day 1 of Period 3. There was a washout period of at least 14 days between injections. Each participant received up to 3 injections. |
| FG005 | LY2/LY3/LY1 | A single, SC injection of 0.5 U/kg LY2605541 from Source 2 on Day 1 of Period 1; from Source 3 on Day 1 of Period 2; and from Source 1 on Day 1 of Period 3. There was a washout period of at least 14 days between injections. Each participant received up to 3 injections. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Treatment Period 1 |
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| Washout Period 1 (at Least 14 Days) |
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| Treatment Period 2 |
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| Washout Period 2 (at Least 14 Days) |
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| Treatment Period 3 |
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All participants who received at least 1 dose of LY2605541.
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.5 U/kg LY2605541 | Participants randomized to receive a single, SC injection of 0.5 U/kg LY2605541 using 3 different PEG sources on Day 1 of each of 3 treatment periods, according to their assigned treatment sequence. |
| 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 Time Curve From Zero to Infinity (AUC[0-∞]) of LY2605541 | LY2605541 exposure in terms of AUC from time 0 extrapolated to infinity (AUC[0-inf]) is summarized for each PEG source (LY1, LY2, or LY3). | Participants who received at least 1 dose of LY2605541 and had evaluable LY2605541 concentration data. | Posted | Geometric Mean | Geometric Coefficient of Variation | picomoles times hours per liter | Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post dose in each period |
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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 | 0.5 U/kg LY2605541 (LY1) | LY2605541: 0.5 U/kg SC injection, single dose from LY1 on Day 1 of 1 of the 3 treatment periods. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | 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 |
|---|---|
| C587357 | LY2605541 |
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The total amount of glucose infused following LY2605541 injection is summarized for each PEG source (LY1, LY2, or LY3). |
| Predose and up to 24 hours post dose in each period |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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| Received at Least One Dose of Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| Received at Least One Dose of Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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| 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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LY2605541: 0.5 U/kg SC injection, single dose from PEG source 2 (LY2) on Day 1 of 1 of the 3 treatment periods. |
| OG002 | 0.5 U/kg LY2605541 (LY3) | LY2605541: 0.5 U/kg SC injection, single dose from PEG source 3 (LY3) on Day 1 of 1 of the 3 treatment periods. |
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| Primary | Pharmacokinetics: Maximum Concentration (Cmax) of LY2605541 | The maximum observed drug concentration (Cmax) of LY2605541 is summarized for each PEG source (LY1, LY2, or LY3). | Participants who received at least 1 dose of LY2605541 and had evaluable LY2605541 concentration data. | Posted | Geometric Mean | Geometric Coefficient of Variation | picomoles per liter | Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post dose in each period |
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| Secondary | Glucodynamics: Maximum Glucose Infusion Rate (Rmax) | The maximum observed glucose infusion rate following LY2605541 injection is summarized for each PEG source (LY1, LY2, or LY3). | Participants who received at least 1 dose of LY2605541 and had evaluable glucose infusion data. | Posted | Geometric Mean | Geometric Coefficient of Variation | milligrams per minute per kilogram | Predose and up to 24 hours post dose in each period |
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| Secondary | Glucodynamics: Total Amount of Glucose Infused (Gtot) | The total amount of glucose infused following LY2605541 injection is summarized for each PEG source (LY1, LY2, or LY3). | Participants who received at least 1 dose of LY2605541 and had evaluable glucose infusion data. | Posted | Geometric Mean | Geometric Coefficient of Variation | milligrams per kilogram | Predose and up to 24 hours post dose in each period |
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| 0 |
| 17 |
| 4 |
| 17 |
| EG001 | 0.5 U/kg LY2605541 (LY2) | LY2605541: 0.5 U/kg SC injection, single dose from LY2 on Day 1 of 1 of the 3 treatment periods. | 0 | 17 | 6 | 17 |
| EG002 | 0.5 U/kg LY2605541 (LY3) | LY2605541: 0.5 U/kg SC injection, single dose from LY3 on Day 1 of 1 of the 3 treatment periods. | 0 | 17 | 3 | 17 |
| Toothache | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Catheter site pain | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Catheter site swelling | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Papule | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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