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| ID | Type | Description | Link |
|---|---|---|---|
| I5T-MC-AACP | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to assess how fast donanemab (LY3002813) gets into the blood stream and how long it takes the body to remove it when administered as single dose in healthy participants. The study will also evaluate the safety and tolerability of donanemab. The study will last up to approximately 22 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Donanemab | Experimental | Participants received a 350 milligrams (mg) intravenous (IV) infusion of donanemab every two weeks for six treatment periods (1 to 6), each lasting two weeks. Treatments were administered on the first day of each period, i.e., days 1, 15, 29, 43, 57, and 71. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Donanemab | Drug | Administered IV. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Four Weeks (AUC[0-4 Weeks]) of Donanemab (i.e) Period 2, Period 4, Period 6. | As per the prespecified analysis, AUC[0-4 weeks] will be calculated as the sum of AUC0-2weeks for:
| Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on days 1, 15, 29, 43, 57, 71 |
| PK: Maximum Observed Concentration During a Dosing Interval at Steady State (Cmax, ss) of Donanemab | PK: Cmax, ss of Donanemab | Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on day 71 |
| PK: Area Under the Concentration Versus Time Curve During a Dosing Interval at Steady State (AUCτ,ss) of Donanemab | PK: AUCτ,ss of Donanemab | Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on day 71 |
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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 |
|---|---|---|---|---|---|---|
| ICON Early Phase Services Lenexa Center | Salt Lake City | Utah | 84124 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Donanemab | Participants received a 350 milligrams (mg) intravenous (IV) infusion of donanemab every two weeks for six treatment periods (1 to 6), each lasting two weeks. Treatments were administered on the first day of each period, i.e., days 1, 15, 29, 43, 57, and 71. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Donanemab | Participants received a 350 mg IV infusion of donanemab every two weeks for six treatment periods (1 to 6), each lasting two weeks. Treatments were administered on the first day of each period, i.e., days 1, 15, 29, 43, 57, and 71. |
| 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 | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Four Weeks (AUC[0-4 Weeks]) of Donanemab (i.e) Period 2, Period 4, Period 6. | As per the prespecified analysis, AUC[0-4 weeks] will be calculated as the sum of AUC0-2weeks for:
| All enrolled participants who received at least one IV infusion of donanemab and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*hour per milliliter (μg*h/mL) | Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on days 1, 15, 29, 43, 57, 71 |
|
Baseline to Week 22
All enrolled participants who received at least one IV infusion of donanemab.
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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 | Donanemab | Participants received a 350 mg IV infusion of donanemab every two weeks for six treatment periods (1 to 6), each lasting two weeks. Treatments were administered on the first day of each period, i.e., days 1, 15, 29, 43, 57, and 71. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | 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 | Dec 12, 2022 | Apr 3, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 1, 2023 | Apr 3, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000729112 | donanemab |
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| years |
|
| 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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|
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| Primary | PK: Maximum Observed Concentration During a Dosing Interval at Steady State (Cmax, ss) of Donanemab | PK: Cmax, ss of Donanemab | All enrolled participants who received at least one IV infusion of donanemab and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on day 71 |
|
|
|
| Primary | PK: Area Under the Concentration Versus Time Curve During a Dosing Interval at Steady State (AUCτ,ss) of Donanemab | PK: AUCτ,ss of Donanemab | All enrolled participants who received at least one IV infusion of donanemab and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg*h/mL | Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on day 71 |
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|
|
| 0 |
| 42 |
| 0 |
| 42 |
| 22 |
| 42 |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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