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| ID | Type | Description | Link |
|---|---|---|---|
| I7X-MC-LLCE | Other Identifier | Eli Lilly and Company |
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The purposes of this study are to determine:
There are three (3) study periods for all participants. Participants will be admitted to the clinical research unit (CRU) each period and will be discharged from the CRU following the completion of 2 overnight stays and up to 36 hours after dosing with LY3202626.
The study will last about 50 days, not including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3202626 (R-Fasting) | Experimental | Single oral dose of LY3202626 (R) capsule under fasting conditions. |
|
| LY3202626 (T1-Fasting) | Experimental | Single oral dose of LY3202626 (T1) tablet under fasting conditions. |
|
| LY3202626 (T1-Fed) | Experimental | Single oral dose of LY3202626 (T1) following a high fat breakfast. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3202626 (R-Fasting) | Drug | Administered orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3202626 | Pharmacokinetics (PK) is the maximum observed drug concentration (Cmax) of LY3202626 | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3202626 | PK is the area under the concentration versus time curve from time zero to infinity (AUC[0-∞]) of LY3202626 | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose |
| PK: AUC From Time Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3202626 | PK is the AUC from time zero to time t, where t is the last time point with a measurable concentration (AUC[0-tlast]) of LY3202626 | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose |
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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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Singapore | 117597 |
Participants were randomized to 1 of 6 sequences in 3 periods.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence (ACB) | A: Reference (R): Single oral 12 milligram (mg) dose of LY3202626 capsule (R) under fasting conditions. B: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions. C: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast. |
| FG001 | Sequence (CAB) | A: Reference (R): Single oral 12 milligram (mg) dose of LY3202626 capsule (R) under fasting conditions. B: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions. C: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast. |
| FG002 | Sequence (BAC) | A: Reference (R): Single oral 12 milligram (mg) dose of LY3202626 capsule (R) under fasting conditions. B: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions. C: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast. |
| FG003 | Sequence (ABC) | A: Reference (R): Single oral 12 milligram (mg) dose of LY3202626 capsule (R) under fasting conditions. B: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions. C: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast. |
| FG004 | Sequence (BCA) | A: Reference (R): Single oral 12 milligram (mg) dose of LY3202626 capsule (R) under fasting conditions. B: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions. C: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast. |
| FG005 | Sequence (CBA) | A: Reference (R): Single oral 12 milligram (mg) dose of LY3202626 capsule (R) under fasting conditions. B: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions. C: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast.. |
| 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 one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Single oral 12 mg dose of LY3202626 capsule (R) under fasting conditions, LY3202626 tablet (T1) under fasting conditions and LY3202626 tablet (T1) following a high-fat meal. |
| 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 (PK): Maximum Observed Drug Concentration (Cmax) of LY3202626 | Pharmacokinetics (PK) is the maximum observed drug concentration (Cmax) of LY3202626 | All randomized participants who received at least one dose and who had evaluable PK data. | Posted | Geometric Mean | Standard Deviation | nanogram/milliliter (ng/mL) | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose |
|
Baseline to End of Study (Up to 3 Months)
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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 | 12 mg LY3202626 (R-Fasting) | Single oral 12 mg dose of LY3202626 capsule (R) under fasting conditions. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Catheter site bruise | General disorders | MedDRA 19.1 | 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 | Sep 10, 2016 | May 8, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 17, 2017 | May 8, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000719000 | LY3202626 |
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| LY3202626 (T1-Fasting) |
| Drug |
Administered orally |
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| LY3202626 (T1-Fed) | Drug | Administered orally |
|
| Singapore |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
| 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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| OG002 | 12 mg LY3202626 (T1-Fed) | Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast. |
|
|
| Primary | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3202626 | PK is the area under the concentration versus time curve from time zero to infinity (AUC[0-∞]) of LY3202626 | All randomized participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Standard Deviation | hour*nanogram/milliliter (h*ng/mL) | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose |
|
|
|
| Primary | PK: AUC From Time Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3202626 | PK is the AUC from time zero to time t, where t is the last time point with a measurable concentration (AUC[0-tlast]) of LY3202626 | All randomized participants who received at least one dose of study drug and who had evaluable PK data. | Posted | Mean | Standard Deviation | h*ng/mL | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose |
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|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 8 |
| 25 |
| EG001 | 12 mg LY3202626 (T1-Fasting) | Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions. | 0 | 26 | 0 | 26 | 7 | 26 |
| EG002 | 12 mg LY3202626 (T1-Fed) | Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast. | 0 | 25 | 0 | 25 | 9 | 25 |
| Catheter site erythema | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Catheter site pruritus | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Catheter site swelling | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Vessel puncture site bruise | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
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