Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I8K-MC-JPDF | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purposes of this study are to determine:
The study has four periods. Individuals will participate in all four periods. Each period will include 4 overnight stays (5 days) in the Clinical Research Unit (CRU).
This study is expected to last up to 8 weeks. This includes the initial screening period, the study or dosing period, and the follow up period.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3337641 (R-fasted) | Experimental | A single, PO dose of reference formulation (R) given orally with water after an overnight fast in one of four periods. |
|
| LY3337641 (T1-fasted) | Experimental | A single, PO dose of LY3337641(20mg) test formulation 1 (T1) given orally with water after an overnight fast in one of four periods. |
|
| LY3337641 (T1-fed) | Experimental | A single, PO dose of LY3337641 (20mg) test formulation 1 (T1) given orally with water after a high fat meal in one of four periods. |
|
| LY3337641 (T2-fasted) | Experimental | A single, PO dose of LY3337641 (20 mg) test formulation 2 (T2) given orally with water after an overnight fast in one of four periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reference Formulation (R) | Drug | Administered PO |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3337641 | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3337641 | Period 1,2,3,4 (Day 1): Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48 and 72 hours postdose |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3337641 | Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of LY3337641 | Period 1,2,3,4 (Day 1): Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48 and 72 hours postdose |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. | Singapore | 117597 |
Not provided
4 period, 4 sequence, randomized crossover study with at least 5 days between doses.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sequence ADBC | A: Reference formulation,1/2 tablet PO in fasted state D: 20 mg LY3337641 (T2fasted),1 tablet PO in fasted state B: 20 mg LY3337641 (T1fasted), 1 tablet PO in fasted state C: 20 mg LY3337641 (T1fed),1 tablet PO in fed state |
| FG001 | Sequence BACD | B: 20 mg LY3337641 (T1fasted), 1 tablet PO in fasted state A: Reference formulation,1/2 tablet PO in fasted state C: 20 mg LY3337641 (T1fed),1 tablet PO in fed state D: 20 mg LY3337641 (T2fasted),1 tablet PO in fasted state |
| FG002 | Sequence CBDA | C: 20 mg LY3337641 (T1fed),1 tablet PO in fed state B: 20 mg LY3337641 (T1fasted), 1 tablet PO in fasted state D: 20 mg LY3337641 (T2fasted),1 tablet PO in fasted state A: Reference formulation,1/2 tablet PO in fasted state |
| FG003 | Sequence DCAB | D: 20 mg LY3337641(T2fasted),1 tablet PO in fasted state C: 20 mg LY3337641 (T1fed),1 tablet PO in fed state A: Reference formulation,1/2 tablet PO in fasted state B: 20 mg LY3337641 (T1fasted), 1 tablet PO in fasted state |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| ||||||||||||||||
| Wash-out |
| ||||||||||||||||
| Period 2 |
| ||||||||||||||||
| Wash-out |
| ||||||||||||||||
| Period 3 |
| ||||||||||||||||
| Wash-out |
| ||||||||||||||||
| Period 4 |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Overall | All randomized participants who received at least 1 dose of study drug. |
| 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): Maximum Observed Drug Concentration (Cmax) of LY3337641 | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3337641 | All randomized participants who received at least 1 dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Period 1,2,3,4 (Day 1): Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48 and 72 hours postdose |
|
2 months
All randomized participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reference Formulation (R-fasted) | A single, PO dose reference formulation (R) with water after an overnight fast in one of four periods |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Catheter site bruise | General disorders | MedDRA 19.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | Clinicaltrials.gov@lilly.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 9, 2017 | Nov 2, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 8, 2017 | Nov 2, 2022 | SAP_001.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| LY3337641 (T1) |
| Drug |
20 mg PO |
|
| LY3337641 (T2) | Drug | 20 mg PO |
|
| Singapore |
| 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 | Singapore |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kilograms per meter squared |
|
A single, PO dose of 20 mg LY3337641 (T1) with water after an overnight fast in one of four periods.
| OG002 | LY3337641 (T1-fed) | A single, PO dose of 20 mg LY3337641 (T1) with water after a high fat meal in one of four periods. |
| OG003 | LY3337641 (T2-fasted) | A single, PO dose of 20 mg LY3337641 (T2)with water after an overnight fast in one of four periods. |
|
|
| Primary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3337641 | Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of LY3337641 | All randomized participants who received at least 1 dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour per milliliter (ng*h/mL) | Period 1,2,3,4 (Day 1): Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48 and 72 hours postdose |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 6 |
| 28 |
| EG001 | LY3337641 (T1-fasted) | A single, PO dose of 20 mg LY3337641 (T1) with water after an overnight fast in one of four periods. | 0 | 29 | 0 | 29 | 4 | 29 |
| EG002 | LY3337641 (T1-fed) | A single, PO dose of 20 mg LY3337641 (T1) with water after a high fat meal in one of four periods. | 0 | 27 | 0 | 27 | 5 | 27 |
| EG003 | LY3337641 (T2-fasted) | A single, PO dose of 20 mg LY3337641 (T2)with water after an overnight fast in one of four periods | 0 | 27 | 0 | 27 | 2 | 27 |
| Catheter site erythema | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Catheter site swelling | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
Not provided