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| ID | Type | Description | Link |
|---|---|---|---|
| I2K-JE-ZZAW | Other Identifier | Eli Lilly and Company |
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The aim of this study is to learn how different doses of LY2624803 affect sleep in healthy Japanese participants. The study has four treatment periods. Participants will receive a single dose of LY2624803 or placebo in each treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.1 milligrams (mg) LY2624803 | Experimental | Single dose of 0.1 mg LY2624803 administered orally in up to 2 of 4 treatment periods |
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| 1.0 mg LY2624803 | Experimental | Single dose of 1.0 mg LY2624803 administered orally in up to 2 of 4 treatment periods |
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| 3.0 mg LY2624803 | Experimental | Single dose of 3.0 mg LY2624803 administered orally in up to 2 of 4 treatment periods |
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| 6.0 mg LY2624803 | Experimental | Single dose of 6.0 mg LY2624803 administered orally in up to 2 of 4 treatment periods |
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| Placebo | Placebo Comparator | Single dose of placebo administered orally in up to 1 of 4 treatment periods |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2624803 - Solution | Drug | Administered orally as reconstituted solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Wake After Sleep Onset (WASO) With LY2624803 Compared to Placebo | WASO was calculated as total time in awake epochs between sleep onset time (first stage 2 epoch) and the end of the primary recording period (8 hours after lights -off). Data presented are Geometric Least Squares (LS) means. Geometric LS mean was calculated using mixed models analysis. The model included factors for treatment, treatment sequence, period and participants. | 8 hours in Periods 1, 2 and 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Latency to Persistent Sleep (LPS) | LPS is defined as the latency from the lights-off time to the first stage 2 sleep followed by at least 10 consecutive minutes of sleep epochs. Data presented are Geometric LS means. Geometric LS mean was calculated using mixed models analysis. The model included factors for treatment, treatment sequence, period and participants. | 8 hours in Periods 1, 2 and 3 |
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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. | Sagamihara |
This was a double-blind, randomized, placebo-controlled, 4-period cross-over study. The first 3 of which were used for polysomnography (PSG) measurements, and the fourth period was used to determine plasma concentrations of LY2624803 to estimate pharmacokinetic (PK) parameters.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Period 1: Single dose of 1 placebo capsule plus placebo solution administered orally. Period 2: Single dose of one 1.0 milligram (mg) LY2624803 capsule plus placebo solution administered orally. Period 3: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally. Period 4: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally. There was at least 7 days washout between each period. |
| FG001 | Cohort 2 | Period 1: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally. Period 2: Single dose of 1 placebo capsule plus placebo solution administered orally. Period 3: Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally. Period 4: Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally. There was at least 7 days washout between each period. |
| FG002 | Cohort 3 | Period 1: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally. Period 2: Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally. Period 3: Single dose of 1 placebo capsule plus placebo solution administered orally. Period 4: Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally. There was at least 7 days washout between each period. |
| FG003 | Cohort 4 | Period 1: Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally. Period 2: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally. Period 3: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally. Period 4: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally. There was at least 7 days washout between each period. |
| FG004 | Cohort 5 | Period 1: Single dose of 1 placebo capsule plus placebo solution administered orally. Period 2: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally. Period 3: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally. Period 4: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally. There was at least 7 days washout between each period. |
| FG005 | Cohort 6 | Period 1: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally. Period 2: Single dose of 1 placebo capsule plus placebo solution administered orally. Period 3: Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally. Period 4: Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally. There was at least 7 days washout between each period. |
| FG006 | Cohort 7 | Period 1: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally. Period 2: Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally. Period 3: Single dose of 1 placebo capsule plus placebo solution administered orally. Period 4: Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally. There was at least 7 days washout between each period. |
| FG007 | Cohort 8 | Period 1: Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally. Period 2: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally. Period 3: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally. Period 4: Single dose of 1.0 mg LY2624803 solution plus 1 placebo capsule administered orally. There was at least 7 days washout between each period. |
| 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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All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Single dose of 0.1 mg LY2624803 oral solution plus 1 placebo capsule, one 1.0, 3.0 or 6.0 mg LY2624803 capsule plus placebo solution administered orally in up to 2 of 4 periods or 1 placebo capsule plus placebo solution administered orally in up to 1 of 4 periods. There was at least 7 days washout between each period. |
| Units | Counts |
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| 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 | Wake After Sleep Onset (WASO) With LY2624803 Compared to Placebo | WASO was calculated as total time in awake epochs between sleep onset time (first stage 2 epoch) and the end of the primary recording period (8 hours after lights -off). Data presented are Geometric Least Squares (LS) means. Geometric LS mean was calculated using mixed models analysis. The model included factors for treatment, treatment sequence, period and participants. | All randomized participants who received at least 1 dose of study drug and had PSG measurements in Periods 1, 2 and 3. | Posted | Geometric Mean | 90% Confidence Interval | minutes (min) | 8 hours in Periods 1, 2 and 3 |
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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 | 0.1 mg LY2624803 - Periods 1-3 | Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Periods 1, 2 and 3. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA 12.1 | 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 |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| LY2624803 - Capsule |
| Drug |
Administered orally as a capsule |
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| Placebo - Solution | Drug | Administered orally as solution |
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| Placebo - Capsule | Drug | Administered orally as a capsule |
|
| Total Sleep Time (TST) | TST is defined as the total time in sleep epochs from sleep onset time to the end of the primary recording period (8 hours after lights -off). LS mean was calculated using mixed models analysis. The model included factors for treatment, treatment sequence, period and participants. | 8 hours in Periods 1, 2 and 3 |
| PK: Maximum Plasma Concentration (Cmax) of LY2624803 After Single Oral Dose in Period 4 | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 10, 12, 18, and 42 hours post-dose in Period 4 |
| PK: Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)] of LY2624803 After Single Oral Dose in Period 4 | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 10, 12, 18, and 42 hours post-dose in Period 4 |
| Japan |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 |
| 1.0 mg LY2624803 |
Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3. |
| OG002 | 3.0 mg LY2624803 | Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3. |
| OG003 | 6.0 mg LY2624803 | Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3. |
| OG004 | Placebo | Single dose of 1 placebo capsule plus placebo solution administered orally in Periods 1, 2 and 3. |
|
|
|
| Secondary | Latency to Persistent Sleep (LPS) | LPS is defined as the latency from the lights-off time to the first stage 2 sleep followed by at least 10 consecutive minutes of sleep epochs. Data presented are Geometric LS means. Geometric LS mean was calculated using mixed models analysis. The model included factors for treatment, treatment sequence, period and participants. | All randomized participants who received at least 1 dose of study drug and had PSG measurements in Periods 1, 2 and 3. | Posted | Geometric Mean | 90% Confidence Interval | min | 8 hours in Periods 1, 2 and 3 |
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|
|
| Secondary | Total Sleep Time (TST) | TST is defined as the total time in sleep epochs from sleep onset time to the end of the primary recording period (8 hours after lights -off). LS mean was calculated using mixed models analysis. The model included factors for treatment, treatment sequence, period and participants. | All randomized participants who received at least 1 dose of study drug and had PSG measurements in Periods 1, 2 and 3. | Posted | Least Squares Mean | 90% Confidence Interval | min | 8 hours in Periods 1, 2 and 3 |
|
|
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| Secondary | PK: Maximum Plasma Concentration (Cmax) of LY2624803 After Single Oral Dose in Period 4 | All randomized participants who received a single oral dose of LY2624803 in Period 4 and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliter (ng/mL) | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 10, 12, 18, and 42 hours post-dose in Period 4 |
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|
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| Secondary | PK: Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)] of LY2624803 After Single Oral Dose in Period 4 | All randomized participants who received a single oral dose of LY2624803 in Period 4 and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms•hour/milliliter (ng•hr/mL) | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 10, 12, 18, and 42 hours post-dose in Period 4 |
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|
| 0 |
| 9 |
| 2 |
| 9 |
| EG001 | 1.0 mg LY2624803 - Periods 1-3 | Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3. | 0 | 17 | 3 | 17 |
| EG002 | 3.0 mg LY2624803 - Periods 1-3 | Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3. | 0 | 17 | 3 | 17 |
| EG003 | 6.0 mg LY2624803 - Periods 1-3 | Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3. | 0 | 8 | 0 | 8 |
| EG004 | Placebo - Periods 1-3 | Single dose of 1 placebo capsule plus placebo solution administered orally in Periods 1, 2 and 3. | 0 | 18 | 3 | 18 |
| EG005 | 0.1 mg LY2624803 - Period 4 | Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Period 4. | 0 | 6 | 0 | 6 |
| EG006 | 1.0 mg LY2624803 - Period 4 | Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4. | 0 | 5 | 2 | 5 |
| EG007 | 3.0 mg LY2624803 - Period 4 | Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4. | 0 | 6 | 1 | 6 |
| EG008 | 6 mg LY2624803 - Period 4 | Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4. | 0 | 5 | 3 | 5 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Feeling abnormal | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Vessel puncture site pain | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| Poor quality sleep | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Upper airway obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| D001523 |
| Mental Disorders |