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| ID | Type | Description | Link |
|---|---|---|---|
| I1R-MC-GLDM | Other Identifier | Eli Lilly and Company |
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Part B of the study no longer required due to new information on the study drug.
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The purpose of this study is to measure how much of the new LY2409021 tablet formulations get into the blood stream and how long it takes the body to get rid of them, compared to the current LY2409021 capsule formulation. In addition, the safety and tolerability of both the new and current formulations will be evaluated. Information about any side effects that may occur will also be collected. The study has two parts. Each participant may enroll in one part only. The study will last up to 8 weeks for each participant. Screening is required prior to the start of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: LY2409021 Capsule | Experimental | Single oral dose of LY2409021 capsule in one of three study periods. |
|
| Part A: LY2409021 Tablet Pre-commercial | Experimental | Single oral dose of LY2409021 tablet (pre-commercial formulation) in one of three study periods. |
|
| Part A: LY2409021 Tablet Commercial | Experimental | Single oral dose of LY2409021 tablet (commercial formulation) in one of three study periods. |
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| Part B: LY2409021 Capsule | Experimental | Single oral dose of LY2409021 capsule in one of two study periods. |
|
| Part B: LY2409021 Tablet Commercial | Experimental | Single oral dose of LY2409021 tablet (commercial formulation) in one of two study periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2409021 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY2409021 | Day 1: Predose, 0.5 Hours (H), 1 H, 4 H, 8 H, 12 H, 24 H, 48 H, 72 H, 96 H, 144 H, 192 H, 264 H, 336 H Postdose in Each Period | |
| PK: Maximum Plasma Concentration (Cmax) of LY2409021 | Day 1: Predose, 0.5 H, 1 H, 4 H, 8 H, 12 H, 24 H, 48 H, 72 H, 96 H, 144 H, 192 H, 264 H, 336 H Postdose in Each Period |
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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 CRU, Inc | Daytona Beach | Florida | 32117 | United States |
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This study was designed to have two parts. During Part A, decision was made to terminate the study. Participants in Part A were allowed to complete the study. Part B was not conducted.
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| ID | Title | Description |
|---|---|---|
| FG000 | LY2409021 Capsules/T2/T3 (Part A) | Period 1: 20 milligrams (mg) LY2409021 administered as capsules once, orally. Period 2: 20 mg LY2409021 administered as a pre-commercial tablet (T2) once, orally. Period 3: 20 mg LY2409021 administered as a commercial tablet (T3) once, orally. There were at least 15 days between doses of study drug (washout). |
| FG001 | LY2409021 T2/Capsules/T3 (Part A) | Period 1: 20 mg LY2409021 administered as T2 once, orally. Period 2: 20 mg LY2409021 administered as capsules once, orally. Period 3: 20 mg LY2409021 administered as T3 once, orally. There were at least 15 days between doses of study drug (washout). |
| FG002 | LY2409021 T3/T2/Capsules (Part A) | Period 1: 20 mg LY2409021 administered as T3 once, orally. Period 2: 20 mg LY2409021 administered as T2 once, orally. Period 3: 20 mg LY2409021 administered as capsules once, orally. There were at least 15 days between doses of study drug (washout). |
| FG003 | LY2409021 T3/Capsules/T2 (Part A) | Period 1: 20 mg LY2409021 administered as T3 once, orally. Period 2: 20 mg LY2409021 administered as capsules once, orally. Period 3: 20 mg LY2409021 administered as T2 once, orally. There were at least 15 days between doses of study drug (washout). |
| FG004 | LY2409021 T2/T3/Capsules (Part A) | Period 1: 20 mg LY2409021 administered as T2 once, orally. Period 2: 20 mg LY2409021 administered as T3 once, orally. Period 3: 20 mg LY2409021 administered as capsules once, orally. There were at least 15 days between doses of study drug (washout). |
| FG005 | LY2409021 Capsules/T3/T2 (Part A) | Period 1: 20 mg LY2409021 administered as capsules once, orally. Period 2: 20 mg LY2409021 administered as T3 once, orally. Period 3: 20 mg LY2409021 administered as T2 once, orally. There were at least 15 days between doses of study drug (washout). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| Period 3 |
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All participants who received at least 1 formulation of LY2409021.
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| ID | Title | Description |
|---|---|---|
| BG000 | LY2409021 (Part A) | 20 mg LY2409021 administered as capsules, T2, or T3 once, orally in each of 3 study periods. |
| 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 Zero to Infinity (AUC[0-inf]) of LY2409021 | All participants who received the LY2409021 formulation and had evaluable AUC(0-inf) values. PK data for 1 participant who met study exclusion criteria was excluded from analyses. This participant only received the capsule formulation. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms x hours/milliliters (ng•h/mL | Day 1: Predose, 0.5 Hours (H), 1 H, 4 H, 8 H, 12 H, 24 H, 48 H, 72 H, 96 H, 144 H, 192 H, 264 H, 336 H Postdose in Each Period |
|
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All participants who received at least 1 formulation of LY2409021.
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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 | LY2409021 Capsules (Part A) | 20 mg LY2409021 administered as capsules once, orally in 1 of 3 study periods. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 17.1 | 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 |
|---|---|
| C000601762 | adomeglivant |
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| Received LY2409021 |
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| Washout |
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| COMPLETED |
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| NOT COMPLETED |
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| Received LY2409021 |
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| Washout |
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| COMPLETED |
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| NOT COMPLETED |
|
| 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 |
|
20 mg LY2409021 administered as T2 once, orally in 1 of 3 study periods.
| OG002 | LY2409021 T3 (Part A) | 20 mg LY2409021 T3 administered once, orally in 1 of 3 study periods. |
|
|
| Primary | PK: Maximum Plasma Concentration (Cmax) of LY2409021 | All participants who received the LY2409021 formulation and had evaluable Cmax values. PK data for 1 participant who met study exclusion criteria was excluded from analyses. This participant only received the capsule formulation. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1: Predose, 0.5 H, 1 H, 4 H, 8 H, 12 H, 24 H, 48 H, 72 H, 96 H, 144 H, 192 H, 264 H, 336 H Postdose in Each Period |
|
|
|
| 0 |
| 15 |
| 4 |
| 15 |
| EG001 | LY2409021 T2 (Part A) | 20 mg LY2409021 administered as T2 once, orally in 1 of 3 study periods. | 0 | 17 | 1 | 17 |
| EG002 | LY2409021 T3 (Part A) | 20 mg LY2409021 administered as T3 once, orally in 1 of 3 study periods. | 0 | 17 | 4 | 17 |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Facial spasm | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
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