Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I4V-JE-JADM | 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
Not provided
Not provided
To evaluate the safety and tolerability of LY3009104 when given orally as single and multiple doses in Japanese healthy subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 mg LY3009104 (Cohort 1) | Experimental | 2mg administered once on day 1 (single dose) |
|
| 5 mg LY3009104 (Cohort 2) | Experimental | 5mg administered once on day 1 (single dose) |
|
| 10 mg LY3009104 (Cohort 3) | Experimental | 10 mg administered on day 1 (single dose) and following a 7 day washout period, administered once daily for 10 days (multiple dose) |
|
| 14 mg LY3009104 (Cohort 4 ) | Experimental | 14 mg administered on day 1 (single dose) and following a 7 day washout period, administered once daily for 10 days (multiple dose) |
|
| Placebo | Placebo Comparator | administered on day 1 (single dose) and following a 7 day washout period, administered once daily for 10 days (multiple dose) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3009104 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinically Significant Effects | Adverse events were considered clinically significant effects. A summary of serious adverse events and other nonserious adverse events are located in the Reported Adverse Event section. | Days 1-10 for Cohorts 1 & 2, Days 1-7 for single dose of Cohorts 3 & 4, Days 8-31 for multiple doses |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum Concentration (Cmax) of LY3009104 | Cmax of Day 1 is Cmax after single dose, and Cmax of Day 17 is Cmax at steady-state. | Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose |
| Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3009104 |
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 1-877-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. | Honolulu | Hawaii |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 2 mg LY3009104 (Baricitinib) | 2 mg administered orally once on Day 1 (single dose) |
| FG001 | 5 mg LY3009104 | 5 mg administered orally once on Day 1 (single dose) |
| FG002 | 10 mg LY3009104 | 10 mg administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days ((multiple dose) |
| FG003 | 14 mg LY3009104 | 14 mg administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days (multiple dose) |
| FG004 | Placebo | administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days (multiple dose) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 2 mg LY3009104 | 2 mg administered orally once on Day 1 (single dose) |
| BG001 | 5 mg LY3009104 | 5 mg administered orally once on Day 1 (single dose) |
| 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 | Number of Participants With Clinically Significant Effects | Adverse events were considered clinically significant effects. A summary of serious adverse events and other nonserious adverse events are located in the Reported Adverse Event section. | Participants who were administered study drug. | Posted | Count of Participants | Participants | No | Days 1-10 for Cohorts 1 & 2, Days 1-7 for single dose of Cohorts 3 & 4, Days 8-31 for multiple doses |
|
From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
Not provided
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 | 2 mg LY3009104 - Single Dose | 2 mg administered orally once on Day 1 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| C000596027 | baricitinib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | Administered orally |
|
AUC is the measure of total plasma exposure of a drug over a given time period. AUC of Day 1 is AUC from 0 to 24 hours. AUC of Day 17 is AUC during one dosing interval at steady-state. |
| Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose |
| Pharmacokinetics: Half-Life(t1/2) of LY3009104 | Half life (t1/2) is the time measured for the plasma concentration of LY3009104 to decrease by one half. | Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose |
| Pharmacokinetics: Apparent Volume of Distribution of LY3009104 | Apparent volume of distribution is used to quantify the distribution of a drug between plasma and the rest of the body after dosing. It is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Day 1, it is apparent volume of distribution during the terminal phase after single dose. Day 17, it is apparent volume of distribution during the terminal phase at steady-state. | Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose |
| Pharmacokinetics: Apparent Total Body Clearance of LY3009104 | Apparent total body clearance is the volume of plasma from which the drug is completely removed in a given time period. For Day 1, it is apparent total body clearance of drug after single dose. For Day 17, it is apparent total body clearance of drug at steady-state. | Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 38 and 48 hours postdose |
| Pharmacokinetics: Time of Maximum Observed LY3009104 Concentration (Tmax) | Tmax is time to reach maximum observed drug concentration. For Day 1, it is tmax after single dose. For Day 17, it is tmax at steady-state. | Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 38 and 48 hours postdose |
| Pharmacokinetics: Renal Excretion of LY3009104 | Percentage of LY3009104 excreted in urine from zero to 24 hours. | Day 1: continuous for 24 hours |
| United States |
| Withdrawal by Subject |
|
| Entry criteria not met |
|
| BG002 | 10 mg LY3009104 | 10 mg administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days ((multiple dose) |
| BG003 | 14 mg LY3009104 | 14 mg administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days (multiple dose) |
| BG004 | Placebo | administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days (multiple dose) |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| OG002 | 10 mg LY3009104 Single Dose | 10 mg administered orally once on Day 1 |
| OG003 | 14 mg LY3009104 Single Dose | 14 mg administered orally once on Day 1 |
| OG004 | Placebo Single Dose | administered orally once on Day 1 |
| OG005 | 10 mg LY3009104 Multiple Dose | Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days |
| OG006 | 14 mg LY3009104 Multiple Dose | Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days |
| OG007 | Placebo Multiple Dose | Following a 7-day washout period, participants in the placebo single-dose group received placebo once daily for 10 days. |
|
|
| Secondary | Pharmacokinetics: Maximum Concentration (Cmax) of LY3009104 | Cmax of Day 1 is Cmax after single dose, and Cmax of Day 17 is Cmax at steady-state. | Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomoles/Liter (nmol/L) | Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose |
|
|
|
| Secondary | Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3009104 | AUC is the measure of total plasma exposure of a drug over a given time period. AUC of Day 1 is AUC from 0 to 24 hours. AUC of Day 17 is AUC during one dosing interval at steady-state. | Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomoles*hour/Liter (nmol*h/L) | Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose |
|
|
|
| Secondary | Pharmacokinetics: Half-Life(t1/2) of LY3009104 | Half life (t1/2) is the time measured for the plasma concentration of LY3009104 to decrease by one half. | Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses. | Posted | Geometric Mean | Full Range | hour (h) | Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose |
|
|
|
| Secondary | Pharmacokinetics: Apparent Volume of Distribution of LY3009104 | Apparent volume of distribution is used to quantify the distribution of a drug between plasma and the rest of the body after dosing. It is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Day 1, it is apparent volume of distribution during the terminal phase after single dose. Day 17, it is apparent volume of distribution during the terminal phase at steady-state. | Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter (L) | Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose |
|
|
|
| Secondary | Pharmacokinetics: Apparent Total Body Clearance of LY3009104 | Apparent total body clearance is the volume of plasma from which the drug is completely removed in a given time period. For Day 1, it is apparent total body clearance of drug after single dose. For Day 17, it is apparent total body clearance of drug at steady-state. | Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter/hour (L/h) | Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 38 and 48 hours postdose |
|
|
|
| Secondary | Pharmacokinetics: Time of Maximum Observed LY3009104 Concentration (Tmax) | Tmax is time to reach maximum observed drug concentration. For Day 1, it is tmax after single dose. For Day 17, it is tmax at steady-state. | Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses. | Posted | Median | Full Range | hour (h) | Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 38 and 48 hours postdose |
|
|
|
| Secondary | Pharmacokinetics: Renal Excretion of LY3009104 | Percentage of LY3009104 excreted in urine from zero to 24 hours. | Participants who were administered study drug (10 mg and 14 mg LY3009104 per protocol) and had pharmacokinetics (PK) samples for the analyses. | Posted | Geometric Mean | Geometric Coefficient of Variation | percentage of drug | Day 1: continuous for 24 hours |
|
|
|
| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | 5 mg LY3009104 - Single Dose | 5 mg administered orally once on Day 1 | 0 | 6 | 1 | 6 |
| EG002 | 10 mg LY3009104 - Single Dose | 10 mg administered orally on Day 1 | 0 | 6 | 2 | 6 |
| EG003 | 14 mg LY3009104 - Single Dose | 14 mg administered orally on Day 1 | 0 | 7 | 7 | 7 |
| EG004 | Placebo - Single Dose | administered orally on Day 1 | 0 | 9 | 6 | 9 |
| EG005 | 10 mg LY3009104 - Multiple Dose | Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days | 0 | 6 | 5 | 6 |
| EG006 | 14 mg LY3009104 - Multiple Dose | Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days | 0 | 6 | 4 | 6 |
| EG007 | Placebo - Multiple Dose | Following a 7-day washout period, participants in the placebo single-dose group received placebo once daily for 10 days. | 0 | 5 | 2 | 5 |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Application Site Reaction | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Chest Discomfort | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Discomfort | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vessel Puncture Site Haematoma | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Oral Herpes | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Neutrophil Count Decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Reticulocyte Count Decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dizziness Postural | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Throat Irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
Not provided