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| ID | Type | Description | Link |
|---|---|---|---|
| I4V-MC-JADO | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| Incyte Corporation | INDUSTRY |
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This will be a 2-part, randomized, participant- and investigator-blind study in healthy males and females.
Part A of this study is to determine a safe and tolerable single oral dose of LY3009104 that yields drug exposures slightly exceeding typical exposures anticipated from repeated administration of an efficacious dose to participants. The concentration of the drug in the blood stream will be measured and information about any side effects that may occur will also be collected.
Part B of this study is to evaluate the effect of LY3009104 on the electrical activity of the heart as measured by electrocardiogram (ECG) in relation to placebo following a single oral dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo matching LY3009104 tablets in size and appearance will be administered orally in 1 out of 3 study periods in Part A and Part B. |
|
| LY3009104 | Experimental | Part A. Single escalating dose of up to 40 milligrams (mg) of LY3009104 administered orally in 2 out of 3 study periods separated by at least a 3 day wash-out period between each dose. Part B. Single dose of LY3009104 determined in Part A administered orally in 1 out of 3 study periods separated by at least a 3 day wash-out period between each period. |
|
| 400 mg moxifloxacin | Active Comparator | Part B. 400 mg moxifloxacin will be administered orally in 1 out of 3 study periods separated by at least a 3 day wash-out period between each period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3009104 | Drug | administered orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Through 24 Hours Postdose in Population-Corrected QT (QTcP) Interval | The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and is calculated from electrocardiogram (ECG) data. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between 2 R waves. Using the population-corrected formula: QTcP = QT/RR^beta, where beta is the population correction factor computed from a log-linear model (ln) QT = alpha+beta*ln RR fitted to all Day -1 and Day 1 predose QT and RR measurements in all periods for all participants. Baseline is the average of data collected for 2 hours before dosing on Day 1 of each period [-2 hours (h), -1.5 h, -1 h, -0.5 h, and 0 h]. The QTcP interval was not assessed during Part A of the study, as specified in the protocol. The QTcP interval at 1 h, 2 h, and 4 h postdose for moxifloxacin was compared to placebo to establish assay sensitivity. | Part B, Periods 1 through 3: Baseline, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, and 24 h postdose |
| Pharmacokinetics: Maximum Concentration (Cmax) of LY3009104 | Parts A and B, Periods 1 through 3: Predose and 0.5 hours (h), 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, 24 h, 36 h, 48 h after administration of study drug | |
| Pharmacokinetics: Area Under the Concentration Curve From Time 0 to Infinity [AUC(0-inf)] of LY3009104 | Parts A and B, Periods 1 through 3: Predose and 0.5 hours (h), 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, 24 h, 36 h, 48 h after administration of study drug | |
| Number of Participants With 1 or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs) | The number of participants with treatment-emergent adverse events (TEAEs) or treatment-emergent SAEs considered by the investigator to be related to study drug is reported. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module. | Baseline through study completion and 30-day follow-up |
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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 from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Daytona Beach | Florida | 32117 |
The study had 2 parts. Part A: single-dose, dose-escalating study of LY3009104 [up to 40 milligrams (mg)] or placebo administered in each period. Part B: assessed the electrophysiological effects of a single supratherapeutic LY3009104 dose compared to a positive control (moxifloxacin) and placebo. Participants enrolled in either Part A or Part B.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: Placebo, 30 mg LY3009104, 40 mg LY3009104 | First Intervention: Placebo tablets [matching 20-mg LY3009104] administered orally once. Second Intervention: 30-mg LY3009104 dose administered orally once. Third Intervention: 40-mg LY3009104 dose administered orally once. There was a washout of at least 3 days between each intervention. |
| FG001 | Part A: 20 mg LY3009104, 30 mg LY3009104, Placebo | First Intervention: 20-mg LY3009104 dose administered orally once. Second Intervention: 30-mg LY3009104 dose administered orally once. Third Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once. There was a washout of at least 3 days between each intervention. |
| FG002 | Part A: 20 mg LY3009104, Placebo, 40 mg LY3009104 | First Intervention: 20-mg LY3009104 dose administered orally once. Second Intervention: Placebo tablets (matching 30-mg LY3009104) administered orally once. Third Intervention: 40-mg LY3009104 dose administered orally once. There was a washout of at least 3 days between each intervention. |
| FG003 | Part B: 40 mg LY3009104, Placebo, Moxifloxacin | First Intervention: 40-mg LY3009104 dose administered orally once. Second Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once. Third Intervention: A single 400-mg moxifloxacin tablet administered orally once. There was a washout of at least 3 days between each intervention. |
| FG004 | Part B: Placebo, Moxifloxacin, 40 mg LY3009104 | First Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once. Second Intervention: A single 400-mg moxifloxacin tablet administered orally once. Third Intervention: 40-mg LY3009104 dose administered orally once. There was a washout of at least 3 days between each intervention. |
| FG005 | Part B: Moxifloxacin, 40 mg LY3009104, Placebo | First Intervention: A single 400-mg moxifloxacin tablet administered orally once. Second Intervention: 40-mg LY3009104 dose administered orally once. Third Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once. There was a washout of at least 3 days between each intervention. |
| FG006 | Part B: Moxifloxacin, Placebo, 40 mg LY3009104 | First Intervention: A single 400-mg moxifloxacin tablet administered orally once. Second Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once. Third Intervention: 40-mg LY3009104 dose administered orally once. There was a washout of at least 3 days between each intervention. |
| FG007 | Part B: 40 mg LY3009104, Moxifloxacin, Placebo | First Intervention: 40-mg LY3009104 dose administered orally once. Second Intervention: A single 400-mg moxifloxacin tablet administered orally once. Third Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once. There was a washout of at least 3 days between each intervention. |
| FG008 | Part B: Placebo, 40 mg LY3009104, Moxifloxacin | First Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once. Second Intervention: 40-mg LY3009104 dose administered orally once. Third Intervention: A single 400-mg moxifloxacin tablet administered orally once. There was a washout of at least 3 days between each intervention. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention and Washout Period 1 |
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| Second Intervention and Washout Period 2 |
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| Third Intervention |
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Participants who received at least 1 dose of LY3009104, moxifloxacin, or placebo and had at least 1 postdose safety assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A (LY3009104 or Placebo) | Participants were randomized to 1 of 3 treatment sequences during Part A of the study and received a single dose (LY3009104 or placebo) in each period separated by a washout of at least 3 days. LY3009104 was administered as either 20-milligrams (mg), 30-mg or 40-mg dose. |
| BG001 |
| 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 | Change From Baseline Through 24 Hours Postdose in Population-Corrected QT (QTcP) Interval | The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and is calculated from electrocardiogram (ECG) data. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between 2 R waves. Using the population-corrected formula: QTcP = QT/RR^beta, where beta is the population correction factor computed from a log-linear model (ln) QT = alpha+beta*ln RR fitted to all Day -1 and Day 1 predose QT and RR measurements in all periods for all participants. Baseline is the average of data collected for 2 hours before dosing on Day 1 of each period [-2 hours (h), -1.5 h, -1 h, -0.5 h, and 0 h]. The QTcP interval was not assessed during Part A of the study, as specified in the protocol. The QTcP interval at 1 h, 2 h, and 4 h postdose for moxifloxacin was compared to placebo to establish assay sensitivity. | Participants enrolled in Part B of the study who had at least 1 dose of study drug (LY3009104, moxifloxacin, or placebo). | Posted | Mean | Standard Deviation | milliseconds (msec) | Part B, Periods 1 through 3: Baseline, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, and 24 h postdose |
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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: Placebo | Placebo tablets [matching 20-milligrams (mg), 30-mg, or 40-mg LY3009104] administered orally once in any period during Part A of the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.1 | 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 |
|---|---|
| C000596027 | baricitinib |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Placebo | Drug | Administered orally |
|
| moxifloxacin | Drug | Administered orally |
|
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Part B (LY3009104, Moxifloxacin, or Placebo) |
Participants were randomized to 1 of 6 treatment sequences during Part B of the study and received a single dose (LY3009104, moxifloxacin, or placebo) in each period separated by a washout of at least 3 days. LY3009104 was administered as a 40-mg dose. Moxifloxacin was administered as a 400-mg tablet. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Part B: Placebo | Placebo tablets (matching LY3009104) administered orally once in any period during Part B of the study. |
| OG001 | Part B: 40 mg LY3009104 | A 40-milligram (mg) dose of LY3009104 administered orally once in any period during Part B of the study. |
| OG002 | Part B: Moxifloxacin | A single 400-mg moxifloxacin tablet administered orally once in any period during Part B of the study. |
|
|
|
| Primary | Pharmacokinetics: Maximum Concentration (Cmax) of LY3009104 | Randomized participants who received at least 1 dose of LY3009104. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomoles per liter (nmol/L) | Parts A and B, Periods 1 through 3: Predose and 0.5 hours (h), 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, 24 h, 36 h, 48 h after administration of study drug |
|
|
|
| Primary | Pharmacokinetics: Area Under the Concentration Curve From Time 0 to Infinity [AUC(0-inf)] of LY3009104 | Randomized participants who received at least 1 dose of LY3009104 and had a predose and at least 1 postdose blood draw for AUC assessment. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*nanomoles per liter (h*nmol/L) | Parts A and B, Periods 1 through 3: Predose and 0.5 hours (h), 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, 24 h, 36 h, 48 h after administration of study drug |
|
|
|
| Primary | Number of Participants With 1 or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs) | The number of participants with treatment-emergent adverse events (TEAEs) or treatment-emergent SAEs considered by the investigator to be related to study drug is reported. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module. | Enrolled participants who had at least 1 dose of study drug (LY3009104, moxifloxacin, or placebo) during the study. | Posted | Count of Participants | Participants | No | Baseline through study completion and 30-day follow-up |
|
|
|
| 0 |
| 8 |
| 2 |
| 8 |
| EG001 | Part A: 20 mg LY3009104 | A 20-mg LY3009104 dose administered orally once in Part A, Period 1 of the study. | 0 | 6 | 1 | 6 |
| EG002 | Part A: 30 mg LY3009104 | A 30-mg LY3009104 dose administered orally once in Part A, Period 2 of the study. | 0 | 6 | 2 | 6 |
| EG003 | Part A: 40 mg LY3009104 | A 40-mg LY3009104 dose administered orally once in Part A, Period 3 of the study. | 0 | 5 | 0 | 5 |
| EG004 | Part B: Placebo | Placebo tablets (matching 40-mg LY3009104) administered orally once in any period during Part B of the study. | 0 | 52 | 8 | 52 |
| EG005 | Part B: 40 mg LY3009104 | A 40-mg LY3009104 dose administered orally once in any period during Part B of the study. | 0 | 53 | 6 | 53 |
| EG006 | Part B: Moxifloxacin | A single 400-mg moxifloxacin tablet administered orally once in any period during Part B of the study. | 0 | 53 | 7 | 53 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Feeling cold | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Genital herpes | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Procedural site reaction | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Blood magnesium decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Urine analysis abnormal | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Increased upper airway secretion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
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| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Drug-Related SAE |
|