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| ID | Type | Description | Link |
|---|---|---|---|
| I4V-MC-JAGU | Other Identifier | Eli Lilly and Company |
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The purposes of this study are to determine:
The study has two parts. Individuals will participate in only one part.
Participants will be admitted to the clinical research unit (CRU) and will be discharged from the CRU following the completion of 3 overnight stays.
Each part of this study will last from 8-10 days, not including screening. Follow-up will occur 7 to 14 days after the last dose of baricitinib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baricitinib T1 (Part A) | Experimental | 4 mg (milligram) baricitinib suspension test formulation (TF) administered orally (PO) without water following a 10 hour fast. (Baricitinib T1) |
|
| Baricitinib T2 (Part A) | Experimental | 4 mg baricitinib suspension formulation (TF) administered PO prior to 240 mL water following a 10 hour fast (Baricitinib T2) |
|
| Baricitinib R (Part A) | Experimental | 4 mg baricitinib tablet administered PO, taken with 240 mL water following a 10 hour fast (baricitinib R) |
|
| Baricitinib TF Fasted (Part B) | Experimental | 4 mg baricitinib suspension test formulation (TF) administered after 10 hour fast. (TF fasting) |
|
| Baricitinib TF Fed (Part B) | Experimental | 4 mg baricitinib suspension TF administered after a high fat meal.(baricitinib TF Fed) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baricitinib suspension | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Baricitinib Following a Single Oral Dose | PK: Cmax of baricitinib after a single oral dose | Predose, 0.25 hour (hr), 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 9 hr, 12 hr, 24 hr, 36 hr, 48 hr postdose |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of Baricitinib Following a Single Oral Dose | PK: AUC(0-tlast) of Baricitinib, measured in hour times nanogram per milliliter (ng*hr/mL) | Predose, 0.25 hour (hr), 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 9 hr, 12 hr, 24 hr, 36 hr, 48 hr postdose |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Baricitinib Following a Single Oral Dose | PK: AUC(0-∞) of Baricitinib | Predose, 0.25 hour (hr), 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 9 hr, 12 hr, 24 hr, 36 hr, 48 hr 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 | Singapore |
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: Sequence ABC | A: 4 mg baricitinib suspension administered orally (PO) without water following a 10 hour fast. (Baricitinib T1) B: 4 mg baricitinib suspension administered PO prior to 240 mL water following a 10 hour fast (Baricitinib T2) C: 4 mg baricitinib tablet administered PO, taken with 240 mL water following a 10 hour fast (baricitinib R) With a 72 hour washout between doses |
| FG001 | Part A: Sequence BCA | B: 4 mg baricitinib suspension administered PO prior to 240 mL water following a 10 hour fast (Baricitinib T2) C: 4 mg baricitinib tablet administered PO, taken with 240 mL water following a 10 hour fast (baricitinib R) A: 4 mg baricitinib suspension administered orally (PO) without water following a 10 hour fast. (Baricitinib T1) With a 72 hour washout between doses |
| FG002 | Part A: Sequence CAB | C: 4 mg baricitinib tablet administered PO, taken with 240 mL water following a 10 hour fast (baricitinib R) A: 4 mg baricitinib suspension administered orally (PO) without water following a 10 hour fast. (Baricitinib T1) B: 4 mg baricitinib suspension administered PO prior to 240 mL water following a 10 hour fast (Baricitinib T2) With a 72 hour washout between doses |
| FG003 | Part B: Sequence DE | D: 4 mg baricitinib suspension test formulation (TF) administered when fasting (TF fasting). E:4 mg baricitinib suspension TF administered after a high fat meal.(baricitinib TF Fed) With a 72 hour washout between doses |
| FG004 | Part B:Sequence ED | E: 4 mg baricitinib suspension TF administered after a high fat meal.(baricitinib TF Fed) D: 4 mg baricitinib suspension test formulation (TF) administered when fasting. (TF fasting) With a 72 hour washout between doses |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| Period 3 |
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| Period 4 |
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| Period 5 |
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All participants in Part A or Part B that received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A:All Participants | All participants who received study drug during Part A. |
| BG001 | Part B: All Participants | All participants who received study drug during Part B. |
| 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 Baricitinib Following a Single Oral Dose | PK: Cmax of baricitinib after a single oral dose | All participants who received at least 1 dose of study drug and had evaluable PK parameters. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Predose, 0.25 hour (hr), 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 9 hr, 12 hr, 24 hr, 36 hr, 48 hr postdose |
|
Baseline through end of study (Up to 120 days)
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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 | Part A: Baricitinib T1 | 4 mg baricitinib suspension administered orally (PO) without water following a 10 hour fast. (Baricitinib T1). |
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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 28, 2016 | Mar 22, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 5, 2017 | Mar 22, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000596027 | baricitinib |
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| Baricitinib tablet | Drug | Administered orally |
|
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| Received at Least 1 Dose of Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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| Received at Least 1 Dose of Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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| Received at Least 1 Dose of Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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| Received at Least 1 Dose of Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| 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 |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kilograms per meter squared (kg/m^2) |
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4 mg baricitinib suspension administered PO prior to 240 mL water following a 10 hour fast (Baricitinib T2)
| OG002 | Part A: Baricitinib R | 4 mg baricitinib tablet administered PO, taken with 240 mL water following a 10 hour fast (baricitinib R) |
| OG003 | Part B: Baricitinib TF Fasted | 4 mg baricitinib suspension test formulation (TF) administered after 10 hour fast (TF fasting). |
| OG004 | Part B: Baricitinib TF Fed | 4 mg baricitinib suspension TF administered after a high fat meal.(baricitinib TF Fed) |
|
|
|
| Primary | PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of Baricitinib Following a Single Oral Dose | PK: AUC(0-tlast) of Baricitinib, measured in hour times nanogram per milliliter (ng*hr/mL) | All participants who received at least 1 dose of study drug and had evaluable PK parameters. | Posted | Geometric Least Squares Mean | Geometric Coefficient of Variation | ng*hr/mL | Predose, 0.25 hour (hr), 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 9 hr, 12 hr, 24 hr, 36 hr, 48 hr postdose |
|
|
|
|
| Primary | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Baricitinib Following a Single Oral Dose | PK: AUC(0-∞) of Baricitinib | All participants who received at least 1 dose of study drug and had evaluable PK parameters. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Predose, 0.25 hour (hr), 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 9 hr, 12 hr, 24 hr, 36 hr, 48 hr postdose |
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|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 2 |
| 24 |
| EG001 | Part A: Baricitinib T2 | 4 mg baricitinib suspension administered PO prior to 240 mL water following a 10 hour fast (Baricitinib T2). | 0 | 24 | 0 | 24 | 1 | 24 |
| EG002 | Part A: Baricitinib R | 4 mg baricitinib tablet administered PO, taken with 240 mL water following a 10 hour fast (baricitinib R) | 0 | 24 | 0 | 24 | 4 | 24 |
| EG003 | Part B: Baricitinib TF Fasted | 4 mg baricitinib suspension test formulation (TF) administered after 10 hour fast (TF fasting). | 0 | 18 | 0 | 18 | 1 | 18 |
| EG004 | Part B: Baricitinib TF Fed | 4 mg baricitinib suspension TF administered after a high fat meal.(baricitinib TF Fed). | 0 | 18 | 0 | 18 | 5 | 18 |
| Catheter site pain | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Catheter site swelling | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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Bioequivalence of s single 4 mg dose of baricitinib as the suspension formulation without (T2) water compared to the commercial tablet (R).
| Ratio |
| 0.998 |
| 2-Sided |
| 95 |
| 0.995 |
| 1.03 |
| Equivalence |
0.80, 1.25 as the bioequivalence boundaries |
| Bioequivalence of single 4 mg dose of baricitinib as fasted vs fed. | ratio | 0.973 | 2-Sided | 95 | 0.936 | 1.01 | Equivalence | 0.80, 1.25 as the bioequivalence boundaries |
Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation with (T1) water compared to the commercial tablet (R).
| Ratio |
| 0.999 |
| 2-Sided |
| 95 |
| 0.966 |
| 1.03 |
| Equivalence |
0.80, 1.25 as the bioequivalence boundaries |
| Bioequivalence of single 4 mg dose of baricitinib as fasted vs fed. | ratio | 0.978 | 2-Sided | 95 | 0.941 | 1.02 | Equivalence | 0.80, 1.25 as the bioequivalence boundaries |