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| ID | Type | Description | Link |
|---|---|---|---|
| I4V-MC-JADH | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| Incyte Corporation | INDUSTRY |
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The purpose of this trial is to assess the effect of 3 formulations on the relative bioavailability of LY3009104. Participants will receive single dose of LY3009104 on 4 separate occasions with and without food. Safety evaluation and serial pharmacokinetic (PK) samples will be collected during each treatment period. Approximately 5 to 7 days of washout period between each treatment and a follow-up visit will occur approximately 5 to 7 days after the last dose of study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3009104 Reference Formulation | Experimental | 8 milligrams (mg) LY3009104 (two 4-mg phosphate salt capsules), administered orally in the fasted state, once only. There will be a washout period of 5 to 7 days between doses of study drug. |
|
| LY3009104 Test Formulation 1 | Experimental | 8 mg LY3009104 (one 8-mg smaller particle free base tablet), administered orally in the fasted state, once only. There will be a washout period of 5 to 7 days between doses of study drug. |
|
| LY3009104 Test Formulation 2 | Experimental | 8 mg LY3009104 (one 8-mg larger particle free base tablet), administered orally in the fasted state, once only. There will be a washout period of 5 to 7 days between doses of study drug. |
|
| LY3009104 Test Formulation 2 + Meal | Experimental | 8 mg LY3009104 (one 8-mg larger particle free base tablet), administered orally with high-fat/high calorie meal, once only. There will be a washout period of 5 to 7 days between doses of study drug. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3009104 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Plasma Concentration-Time Curve (AUC) | The area under the concentration-time curve from time 0 to infinity [AUC(0-inf)] is reported for participants who received either LY3009104 tablets or capsules in a fasted or fed state. | Predose up to 48 hours postdose for each of the 4 treatment periods |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum Plasma Concentration (Cmax) | Predose up to 48 hours postdose for each of the 4 treatment periods | |
| Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) | Predose up to 48 hours postdose for each of the 4 treatment periods |
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Inclusion Criteria:
Male Participants:
Female participants:
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. | Singapore | 117597 |
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| ID | Title | Description |
|---|---|---|
| FG000 | LY3009104 (LY) RF, LY 50-mcm Fed, LY 20-mcm, LY 50-mcm Fasted | First intervention: 8-milligram (mg) dose of LY3009104 reference formulation (RF, two 4-mg phosphate salt capsules) administered once in a fasted state. Second intervention: 8-mg dose of LY3009104 test formulation 2 [TF2, one 8-mg tablet, free base formulation, target active pharmaceutical ingredient (API) particle size of 50 micrometers (mcm)] administered once with a high-fat, high calorie meal. Third intervention: 8-mg dose of LY3009104 test formulation 1 (TF1, one 8-mg tablet, free base formulation, target API particle size of 20 mcm) administered once in a fasted state. Fourth intervention: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state. There was a washout period of 5 to 7 days between doses of study drug. |
| FG001 | LY 20-mcm, LY RF, LY 50-mcm Fasted, LY 50-mcm Fed | First intervention: 8-mg dose of LY3009104 TF1 (one 8-mg tablet, free base formulation, target API particle size of 20 mcm) administered once in a fasted state. Second intervention: 8-mg dose of LY3009104 RF (two 4-mg phosphate salt capsules) administered once in a fasted state. Third intervention: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state. Fourth intervention: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once with a high-fat, high calorie meal. There was a washout period of 5 to 7 days between doses of study drug. |
| FG002 | LY 50-mcm Fasted, LY 20-mcm, LY 50-mcm Fed, LY RF | First intervention: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state. Second intervention: 8-mg dose of LY3009104 TF1 (one 8-mg tablet, free base formulation, target API particle size of 20 mcm) administered once in a fasted state. Third intervention: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once with a high-fat, high calorie meal. Fourth intervention: 8-mg dose of LY3009104 RF (two 4-mg phosphate salt capsules) administered once in a fasted state. There was a washout period of 5 to 7 days between doses of study drug. |
| FG003 | LY 50-mcm Fed, LY 50-mcm Fasted, LY RF, LY 20-mcm | First intervention: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once with a high-fat, high calorie meal. Second intervention: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state. Third intervention: 8-mg dose of LY3009104 RF (two 4-mg phosphate salt capsules) administered once in a fasted state. Fourth Intervention: 8-mg dose of LY3009104 TF1 (one 8-mg tablet, free base formulation, target API particle size of 20 mcm) administered once in a fasted state. There was a washout period of 5 to 7 days between doses of study drug. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes groups randomized to receive any of the following study drugs as the first intervention. LY3009104 Reference Formulation (RF): 8-milligram (mg) dose of LY3009104 RF (two 4-mg phosphate salt capsules) administered once in a fasted state. LY3009104 Test Formulation 1 (TF1), 20 micrometers (mcm): 8-mg dose of LY3009104 TF1 [one 8-mg tablet, free base formulation, target active pharmaceutical ingredient (API) particle size of 20 mcm] administered once in a fasted state. LY3009104 Test Formulation 2 (TF2), 50 mcm, fasted: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state. LY3009104 TF2, 50 mcm, fed: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once with a high-fat, high calorie 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: Plasma Concentration-Time Curve (AUC) | The area under the concentration-time curve from time 0 to infinity [AUC(0-inf)] is reported for participants who received either LY3009104 tablets or capsules in a fasted or fed state. | Randomized participants who received at least 1 dose of study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomoles*hours per liter (nmol*h/L) | Predose up to 48 hours postdose for each of the 4 treatment periods |
|
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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 | LY3009104 Reference Formulation | 8-milligram (mg) dose of LY3009104 reference formulation (RF, two 4-mg phosphate salt capsules) administered once in a fasted state in Period 1, 2, 3, or 4. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Glossodynia | Gastrointestinal disorders | MedDRA 14.0 | 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 |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C000596027 | baricitinib |
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| Singapore |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
|
8-mg dose of LY3009104 test formulation 1 [TF1, one 8-mg tablet, free base formulation, target active pharmaceutical ingredient (API) particle size of 20 micrometers (mcm)] administered once in a fasted state in Period 1, 2, 3, or 4. |
| OG002 | LY3009104 Test Formulation 2 (50-mcm, Fed) | 8-mg dose of LY3009104 test formulation 2 (TF2, one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once with a high-fat, high calorie meal in Period 1, 2, 3, or 4. |
| OG003 | LY3009104 Test Formulation 2 (50-mcm, Fasted) | 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state in Period 1, 2, 3, or 4. |
|
|
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| Secondary | Pharmacokinetics: Maximum Plasma Concentration (Cmax) | Randomized participants who received at least 1 dose of study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomoles per liter (nmol/L) | Predose up to 48 hours postdose for each of the 4 treatment periods |
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|
|
|
| Secondary | Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) | Randomized participants who received at least 1 dose of study drug. | Posted | Median | Full Range | hours (h) | Predose up to 48 hours postdose for each of the 4 treatment periods |
|
|
|
|
| 0 |
| 15 |
| 1 |
| 15 |
| EG001 | LY3009104 Test Formulation 2 (50-mcm, Fed) | 8-mg dose of LY3009104 test formulation 2 [TF2, one 8-mg tablet, free base formulation, target active pharmaceutical ingredient (API) particle size of 50 micrometer (mcm)] administered once with a high-fat, high calorie meal in Period 1, 2, 3, or 4. | 0 | 15 | 5 | 15 |
| EG002 | LY3009104 Test Formulation 1 (20-mcm) | 8-mg dose of LY3009104 test formulation 1 (TF1, one 8-mg tablet, free base formulation, target API particle size of 20 mcm) administered once in a fasted state in Period 1, 2, 3, or 4. | 0 | 15 | 2 | 15 |
| EG003 | LY3009104 Test Formulation 2 (50-mcm, Fasted) | 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state in Period 1, 2, 3, or 4. | 0 | 15 | 2 | 15 |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Catheter site erythema | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Catheter site haematoma | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Catheter site pain | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Catheter site pruritus | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Vessel puncture site haematoma | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Procedural site reaction | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Geometric LS mean ratio |
| 0.962 |
| 2-Sided |
| 90 |
| 0.852 |
| 1.08 |
The geometric LS mean ratio (TF2 fasted divided by RF fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant. |
| Superiority or Other |
| Geometric LS mean ratio | 0.820 | 2-Sided | 90 | 0.727 | 0.925 | The geometric LS mean ratio (TF2 fed divided by TF2 fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant. | Superiority or Other |
| 0.960 |
| Median Difference (Final Values) |
| 0 |
| 2-Sided |
| 90 |
| -0.250 |
| 0.750 |
The median difference was calculated as TF2 fasted minus RF fasted. |
| Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.006 | Median Difference (Final Values) | 0.500 | 2-Sided | 90 | 0 | 2.00 | The median difference was calculated as TF2 fed minus TF2 fasted. | Superiority or Other |