Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| H8H-MC-LAIF | Other Identifier | Eli Lilly and Company |
Not provided
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The purpose of this study is to evaluate the effect of lasmiditan on simulated driving performance in healthy participants. Participants are expected to complete each of four study periods, which will last a total of about 10 days. During this time, participants will remain in the clinical research unit. Screening must be completed within 28 days before the start of the study. Follow-up will be completed about one week after discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo administered orally in one of four study periods. |
|
| 100 milligrams (mg) Lasmiditan | Experimental | 100 mg lasmiditan administered orally in one of four study periods. |
|
| 200 mg Lasmiditan | Experimental | 200 mg lasmiditan administered orally in one of four study periods. |
|
| Diphenhydramine | Active Comparator | 50 mg diphenhydramine administered orally in one of four study periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lasmiditan | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Simulated Driving Performance in Healthy Participants as Measured by Standard Deviation of Lateral Position (SDLP) Using the Cognitive Research Corporation Driving Simulator-MiniSim (CRCDS-MiniSim) | The standard deviation of lateral position (SDLP) is the primary parameter used as stable measure of driving performance with high test-retest reliability. It measures the driver's ability to stay in a constant position within the driving lane. LS Means were analyzed using a mixed repeated measures model with fixed effects for sequence, period, and treatment, with repeated observations for subjects for each of the driving time points. | 8 hours postdose in each dosing period |
| Simulated Driving Performance in Healthy Participants as Measured by Standard Deviation of Lateral Position (SDLP) Using the Cognitive Research Corporation Driving Simulator-MiniSim (CRCDS-MiniSim) | The standard deviation of lateral position (SDLP) is the primary parameter used as stable measure of driving performance with high test-retest reliability. It measures the driver's ability to stay in a constant position within the driving lane. LS Means were analyzed using a mixed repeated measures model with fixed effects for sequence, period, and treatment, with repeated observations for subjects for each of the driving time points. | 12 hours postdose in each dose period |
| Simulated Driving Performance in Healthy Participants as Measured by Standard Deviation of Lateral Position (SDLP) Using the Cognitive Research Corporation Driving Simulator-MiniSim (CRCDS-MiniSim) | The standard deviation of lateral position (SDLP) is the primary parameter used as stable measure of driving performance with high test-retest reliability. It measures the driver's ability to stay in a constant position within the driving lane. LS Means were analyzed using a mixed repeated measures model with fixed effects for sequence, period, and treatment, with repeated observations for subjects for each of the driving time points. | 24 hours post dose in each dose period |
| Measure | Description | Time Frame |
|---|---|---|
| Karolinska Sleepiness Scale (KSS) Score | The KSS is used to assess subjective level of sleepiness. This is a participant self-report measure of situational sleepiness and provides an assessment of alertness/sleepiness at a particular point in time. It is a 9-point categorical Likert scale on which the participant rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep), with higher scores indicating more sleepiness and lower scores indicating more alertness. |
Not provided
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 |
|---|---|---|---|---|---|---|
| Covance Clinical Research Inc | Daytona Beach | Florida | 32117 | United States | ||
| Covance |
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Randomized, 4-period cross-over study in healthy participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | Period 1: Placebo administered PO. Period 2: 100 mg lasmiditan administered PO. Period 3: 50 mg diphenhydramine administered PO. Period 4: 200 mg lasmiditan administered PO. Study treatments were administered at up to 4 dosing occasions (0, 6, and 10 hours on Day 1 and 22 hours on Day 2) within each period: lasmiditan was only administered at 0 hours. Each period is 3 days duration |
| FG001 | Sequence 2 | Period 1: 100 mg lasmiditan administered PO. Period 2: 200 mg lasmiditan administered PO. Period 3: Placebo administered PO. Period 4: 50 mg diphenhydramine administered PO. Study treatments were administered at up to 4 dosing occasions (0, 6, and 10 hours on Day 1 and 22 hours on Day 2) within each period: lasmiditan was only administered at 0 hours. Each period is 3 days duration |
| FG002 | Sequence 3 | Period 1: 200 mg lasmiditan administered PO Period 2 : 50 mg diphenhydramine administered PO Period 3: 100 mg lasmiditan administered PO Period 4: Placebo administered PO Study treatments were administered at up to 4 dosing occasions (0, 6, and 10 hours on Day 1 and 22 hours on Day 2) within each period: lasmiditan was only administered at 0 hours. Each period is 3 days duration |
| FG003 | Sequence 4 | Period 1: 50 mg diphenhydramine administered PO Period 2: Placebo administered PO Period 3: 200 mg lasmiditan administered PO Period 4: 100 mg lasmiditan administered PO Study treatments were administered at up to 4 dosing occasions (0, 6, and 10 hours on Day 1 and 22 hours on Day 2) within each period: lasmiditan was only administered at 0 hours. Each period is 3 days duration |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| ||||||||||||||||
| Period 2 |
| ||||||||||||||||
| Period 3 |
| ||||||||||||||||
| Period 4 |
|
All randomized participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sequence 1 | Participants received Placebo, 100 mg lasmiditan, 200 mg lasmiditan, 50 mg diphenhydramine as per below sequence. Period 1: Placebo administered PO. Period 2: 100 mg lasmiditan administered PO. Period 3: 50 mg diphenhydramine administered PO. Period 4: 200 mg lasmiditan administered PO. Study treatments were administered at up to 4 dosing occasions (0, 6, and 10 hours on Day 1 and 22 hours on Day 2) within each period: lasmiditan was only administered at 0 hours. Each period is 3 days duration |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Simulated Driving Performance in Healthy Participants as Measured by Standard Deviation of Lateral Position (SDLP) Using the Cognitive Research Corporation Driving Simulator-MiniSim (CRCDS-MiniSim) | The standard deviation of lateral position (SDLP) is the primary parameter used as stable measure of driving performance with high test-retest reliability. It measures the driver's ability to stay in a constant position within the driving lane. LS Means were analyzed using a mixed repeated measures model with fixed effects for sequence, period, and treatment, with repeated observations for subjects for each of the driving time points. | All randomized participants who received at least 1 dose of study drug and had evaluable data. | Posted | Least Squares Mean | Full Range | centimeters | 8 hours postdose in each dosing period |
|
up to 4 months
All randomized participants who received at least 1 dose of study drug.
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 | Placebo | Placebo administered orally in one of four study periods. | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | Clinicaltrials.gov@lilly.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 21, 2018 | Nov 1, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 22, 2018 | Nov 1, 2019 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C554777 | lasmiditan |
| D004155 | Diphenhydramine |
| ID | Term |
|---|---|
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D001559 | Benzhydryl Compounds |
Not provided
Not provided
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| Placebo | Drug | Administered orally |
|
| Diphenhydramine | Drug | Administered orally |
|
| 8 hours postdose in each dose period |
| Karolinska Sleepiness Scale (KSS) Score | The KSS is used to assess subjective level of sleepiness. This is a participant self-report measure of situational sleepiness and provides an assessment of alertness/sleepiness at a particular point in time. It is a 9-point categorical Likert scale on which the participant rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep), with higher scores indicating more sleepiness and lower scores indicating more alertness. | 12 hours postdose in each dose period |
| Karolinska Sleepiness Scale (KSS) Score | The KSS is used to assess subjective level of sleepiness. This is a participant self-report measure of situational sleepiness and provides an assessment of alertness/sleepiness at a particular point in time. It is a 9-point categorical Likert scale on which the participant rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep), with higher scores indicating more sleepiness and lower scores indicating more alertness. | 24 hours postdose in each dose period |
| Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test | The SDC Test, a digit symbol substitution test that is sensitive to changes in information processing speed, provides measures of response speed and accuracy. The test was administered prior to the simulated driving sessions. The principal test score measures the number of correct responses in 120 seconds. SDC was used in this study to measure attention, visual scanning, working memory, and speed of information processing. A measure of recall accuracy A higher score indicates greater processing speed | 8 hours postdose in each dose period |
| Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test | The SDC Test, a digit symbol substitution test that is sensitive to changes in information processing speed, provides measures of response speed and accuracy. The test was administered prior to the simulated driving sessions. The principal test score measures the number of correct responses in 120 seconds. SDC was used in this study to measure attention, visual scanning, working memory, and speed of information processing. Scores range from 0 (No correct responses). A higher score indicates greater processing speed. | 12 hours postdose in each dose period |
| Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test | The SDC Test, a digit symbol substitution test that is sensitive to changes in information processing speed, provides measures of response speed and accuracy. The test was administered prior to the simulated driving sessions. The principal test score measures the number of correct responses in 120 seconds. SDC was used in this study to measure attention, visual scanning, working memory, and speed of information processing. Scores range from 0 (No correct responses). A higher score indicates greater processing speed. | 24 hours postdose in each dose period |
| Total Number of Collisions | Total collisions are the sum off collisions with other vehicles and off-road crashes. Collision counts also included the number of times that a lane deviation exceeded 4 feet but where no collision occurred ( a crash-likely event). | 8 hours postdose in each dose period |
| Total Number of Collisions | Total collisions are the sum off collisions with other vehicles and off-road crashes. Collision counts also included the number of times that a lane deviation exceeded 4 feet but where no collision occurred ( a crash-likely event). | 12 hours postdose in each dose period |
| Total Number of Collisions | Total collisions are the sum off collisions with other vehicles and off-road crashes. Collision counts also included the number of times that a lane deviation exceeded 4 feet but where no collision occurred ( a crash-likely event). | 24 hours postdose in each dose period |
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan | PK: Cmax of Lasmiditan | Day 1: Predose, 0.5 hour (hr), 1hr, 1.5hr, 2hr, 3hr, 4hr, 6hr, 8hr, 10 hr, 12hr, 24hr, 36hr, 48hr postdose |
| PK: Area Under the Concentration Versus Time Curve (AUC) of Lasmiditan to the Last Timepoint (0-tlast) | PK: AUC of Lasmiditan until the last time a concentration is detected. | Day 1: Predose, 0.5 hour (hr), 1hr, 1.5hr, 2hr, 3hr, 4hr, 6hr, 8hr, 10 hr, 12hr, 24hr, 36hr, 48hr postdose |
| Dallas |
| Texas |
| 75247-4989 |
| United States |
| Covance Clinical Research Inc | Madison | Wisconsin | 53704 | United States |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Sequence 2 | Participants received Placebo, 100 mg lasmiditan, 200 mg lasmiditan, 50 mg diphenhydramine as per below sequence. Period 1: 100 mg lasmiditan administered PO. Period 2: 200 mg lasmiditan administered PO. Period 3: Placebo administered PO. Period 4: 50 mg diphenhydramine administered PO. Study treatments were administered at up to 4 dosing occasions (0, 6, and 10 hours on Day 1 and 22 hours on Day 2) within each period: lasmiditan was only administered at 0 hours. Each period is 3 days duration |
| BG002 | Sequence 3 | Participants received Placebo, 100 mg lasmiditan, 200 mg lasmiditan, 50 mg diphenhydramine as per below sequence. Period 1: 200 mg lasmiditan administered PO Period 2 : 50 mg diphenhydramine administered PO Period 3: 100 mg lasmiditan administered PO Period 4: Placebo administered PO Study treatments were administered at up to 4 dosing occasions (0, 6, and 10 hours on Day 1 and 22 hours on Day 2) within each period: lasmiditan was only administered at 0 hours. Each period is 3 days duration |
| BG003 | Sequence 4 | Participants received Placebo, 100 mg lasmiditan, 200 mg lasmiditan, 50 mg diphenhydramine as per below sequence. Period 1: 50 mg diphenhydramine administered PO Period 2: Placebo administered PO Period 3: 200 mg lasmiditan administered PO Period 4: 100 mg lasmiditan administered PO Study treatments were administered at up to 4 dosing occasions (0, 6, and 10 hours on Day 1 and 22 hours on Day 2) within each period: lasmiditan was only administered at 0 hours. Each period is 3 days duration |
| BG004 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| OG001 | 100 mg Lasmiditan | 100 milligrams (mg) Lasmiditan administered orally (PO) in one of four study periods. |
| OG002 | 200 mg Lasmiditan | 200 mg Lasmiditan administered PO in one of four study periods. |
| OG003 | 50 mg Diphenhydramine | Diphenhydramine administered PO in one of four study periods. |
|
|
|
| Primary | Simulated Driving Performance in Healthy Participants as Measured by Standard Deviation of Lateral Position (SDLP) Using the Cognitive Research Corporation Driving Simulator-MiniSim (CRCDS-MiniSim) | The standard deviation of lateral position (SDLP) is the primary parameter used as stable measure of driving performance with high test-retest reliability. It measures the driver's ability to stay in a constant position within the driving lane. LS Means were analyzed using a mixed repeated measures model with fixed effects for sequence, period, and treatment, with repeated observations for subjects for each of the driving time points. | All randomized participants who received at least 1 dose of study drug and had evaluable data. | Posted | Least Squares Mean | Full Range | centimeters | 12 hours postdose in each dose period |
|
|
|
|
| Primary | Simulated Driving Performance in Healthy Participants as Measured by Standard Deviation of Lateral Position (SDLP) Using the Cognitive Research Corporation Driving Simulator-MiniSim (CRCDS-MiniSim) | The standard deviation of lateral position (SDLP) is the primary parameter used as stable measure of driving performance with high test-retest reliability. It measures the driver's ability to stay in a constant position within the driving lane. LS Means were analyzed using a mixed repeated measures model with fixed effects for sequence, period, and treatment, with repeated observations for subjects for each of the driving time points. | All randomized participants who received at least 1 dose of study drug and had evaluable data. | Posted | Least Squares Mean | Full Range | centimeters | 24 hours post dose in each dose period |
|
|
|
|
| Secondary | Karolinska Sleepiness Scale (KSS) Score | The KSS is used to assess subjective level of sleepiness. This is a participant self-report measure of situational sleepiness and provides an assessment of alertness/sleepiness at a particular point in time. It is a 9-point categorical Likert scale on which the participant rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep), with higher scores indicating more sleepiness and lower scores indicating more alertness. | All randomized participant that received at least 1 dose of study drug and had evaluable data. | Posted | Mean | Standard Deviation | Units on a scale | 8 hours postdose in each dose period |
|
|
|
|
| Secondary | Karolinska Sleepiness Scale (KSS) Score | The KSS is used to assess subjective level of sleepiness. This is a participant self-report measure of situational sleepiness and provides an assessment of alertness/sleepiness at a particular point in time. It is a 9-point categorical Likert scale on which the participant rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep), with higher scores indicating more sleepiness and lower scores indicating more alertness. | All randomized participants who received at least 1 dose of study drug and had evaluable data. | Posted | Mean | Standard Deviation | units on a scale | 12 hours postdose in each dose period |
|
|
|
|
| Secondary | Karolinska Sleepiness Scale (KSS) Score | The KSS is used to assess subjective level of sleepiness. This is a participant self-report measure of situational sleepiness and provides an assessment of alertness/sleepiness at a particular point in time. It is a 9-point categorical Likert scale on which the participant rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep), with higher scores indicating more sleepiness and lower scores indicating more alertness. | All randomized participants that received at least 1 dose of study drug and had evaluable data. | Posted | Mean | Standard Deviation | units on a scale | 24 hours postdose in each dose period |
|
|
|
|
| Secondary | Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test | The SDC Test, a digit symbol substitution test that is sensitive to changes in information processing speed, provides measures of response speed and accuracy. The test was administered prior to the simulated driving sessions. The principal test score measures the number of correct responses in 120 seconds. SDC was used in this study to measure attention, visual scanning, working memory, and speed of information processing. A measure of recall accuracy A higher score indicates greater processing speed | All randomized participant that received at least 1 dose of study drug and had evaluable data. | Posted | Mean | Standard Deviation | Correct responses | 8 hours postdose in each dose period |
|
|
|
|
| Secondary | Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test | The SDC Test, a digit symbol substitution test that is sensitive to changes in information processing speed, provides measures of response speed and accuracy. The test was administered prior to the simulated driving sessions. The principal test score measures the number of correct responses in 120 seconds. SDC was used in this study to measure attention, visual scanning, working memory, and speed of information processing. Scores range from 0 (No correct responses). A higher score indicates greater processing speed. | All randomized participants who received study drug and have evaluable data. | Posted | Mean | Standard Deviation | Correct responses | 12 hours postdose in each dose period |
|
|
|
|
| Secondary | Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test | The SDC Test, a digit symbol substitution test that is sensitive to changes in information processing speed, provides measures of response speed and accuracy. The test was administered prior to the simulated driving sessions. The principal test score measures the number of correct responses in 120 seconds. SDC was used in this study to measure attention, visual scanning, working memory, and speed of information processing. Scores range from 0 (No correct responses). A higher score indicates greater processing speed. | All randomized participants who received study drug and have evaluable data. | Posted | Mean | Standard Deviation | Correct responses | 24 hours postdose in each dose period |
|
|
|
|
| Secondary | Total Number of Collisions | Total collisions are the sum off collisions with other vehicles and off-road crashes. Collision counts also included the number of times that a lane deviation exceeded 4 feet but where no collision occurred ( a crash-likely event). | All randomized participants who received at least 1 dose of study drug and had evaluable data. | Posted | Mean | Standard Deviation | collisions | 8 hours postdose in each dose period |
|
|
|
|
| Secondary | Total Number of Collisions | Total collisions are the sum off collisions with other vehicles and off-road crashes. Collision counts also included the number of times that a lane deviation exceeded 4 feet but where no collision occurred ( a crash-likely event). | All randomized participants who received at least 1 dose of study drug and had evaluable data. | Posted | Mean | Standard Deviation | collisions | 12 hours postdose in each dose period |
|
|
|
|
| Secondary | Total Number of Collisions | Total collisions are the sum off collisions with other vehicles and off-road crashes. Collision counts also included the number of times that a lane deviation exceeded 4 feet but where no collision occurred ( a crash-likely event). | All randomized participants who received at least 1 dose of study drug and had evaluable data. | Posted | Mean | Standard Deviation | collisions | 24 hours postdose in each dose period |
|
|
|
|
| Secondary | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan | PK: Cmax of Lasmiditan | All randomized participants who received at least 1 dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter | Day 1: Predose, 0.5 hour (hr), 1hr, 1.5hr, 2hr, 3hr, 4hr, 6hr, 8hr, 10 hr, 12hr, 24hr, 36hr, 48hr postdose |
|
|
|
| Secondary | PK: Area Under the Concentration Versus Time Curve (AUC) of Lasmiditan to the Last Timepoint (0-tlast) | PK: AUC of Lasmiditan until the last time a concentration is detected. | All randomized participants who received at least 1 dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hour per milliliter | Day 1: Predose, 0.5 hour (hr), 1hr, 1.5hr, 2hr, 3hr, 4hr, 6hr, 8hr, 10 hr, 12hr, 24hr, 36hr, 48hr postdose |
|
|
|
| 67 |
| 0 |
| 67 |
| 6 |
| 67 |
| EG001 | 100 mg Lasmiditan | 100 milligrams (mg) Lasmiditan administered orally (PO) in one of four study periods. | 0 | 68 | 0 | 68 | 23 | 68 |
| EG002 | 200 mg Lasmiditan | 200 mg Lasmiditan administered PO in one of four study periods. | 0 | 68 | 0 | 68 | 25 | 68 |
| EG003 | 50 mg Diphenhydramine | Diphenhydramine administered PO in one of four study periods. | 0 | 68 | 0 | 68 | 7 | 68 |
| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
Not provided
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| Mixed Models Analysis |
| <0.0001 |
| Difference in LS Means |
| -0.32 |
| 2-Sided |
| 95 |
| -1.51 |
| 0.88 |
| Non-Inferiority |
Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means < 4.4. |
| Mixed Models Analysis | <0.0001 | Difference in LS Means | 4.31 | 2-Sided | 95 | 3.17 | 5.45 | Non-Inferiority | Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means < 4.4. |
| Mixed Models Analysis |
| <0.0001 |
| Difference in LS Means |
| -1.04 |
| 2-Sided |
| 95 |
| -2.40 |
| 0.32 |
| Non-Inferiority |
Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means < 4.4. |
| Mixed Models Analysis | <0.0001 | Difference in LS Means | 4.05 | 2-Sided | 95 | 2.73 | 5.38 | Non-Inferiority | Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means < 4.4. |
| Difference of Least Square Means |
| 0.66 |
| 2-Sided |
| 95 |
| 0.22 |
| 1.10 |
| Superiority |
| Difference of Least Square Means | 0.81 | 2-Sided | 95 | 0.39 | 1.24 | Superiority |
| Differnce of Least Square Means |
| 0.34 |
| 2-Sided |
| 95 |
| -0.14 |
| 0.82 |
| Superiority |
| Difference of Least Square Means | 1.29 | 2-Sided | 95 | 0.81 | 1.78 | Superiority |
| Difference of Least Square Means |
| -0.40 |
| 2-Sided |
| 95 |
| -0.89 |
| 0.09 |
| Superiority |
| Difference of Least Square Means | 0.44 | 2-Sided | 95 | -0.09 | 0.96 | Superiority |
| Difference in Lease Square Means |
| -0.74 |
| 2-Sided |
| 95 |
| -2.49 |
| 1.01 |
| Superiority |
| Difference in Least Square Means | -0.72 | 2-Sided | 95 | -2.32 | 0.89 | Superiority |
| Difference in Least Square Means |
| -0.29 |
| 2-Sided |
| 95 |
| -2.00 |
| 1.42 |
| Superiority |
| Difference in Least Square Means | -3.81 | 2-Sided | 95 | -5.53 | -2.08 | Superiority |
| Difference of Least Square Means |
| -0.31 |
| 2-Sided |
| 95 |
| -1.71 |
| 1.08 |
| Superiority |
| Difference of Least Square Means | -2.70 | 2-Sided | 95 | -4.13 | -1.27 | Superiority |
| Mean Difference (Final Values) |
| -0.04 |
| Standard Deviation |
| 0.27 |
| 2-Sided |
| Superiority |
| Wilcoxon Signed Rank test | 0.0115 | Mean Difference (Final Values) | 0.30 | Standard Deviation | 1.00 | 2-Sided | Superiority |
| Mean Difference (Final Values) |
| -0.04 |
| Standard Deviation |
| 0.44 |
| 2-Sided |
| Superiority |
| Wilcoxon Signed Rank test | 0.0938 | Mean Difference (Final Values) | 0.12 | Standard Deviation | 0.54 | 2-Sided | Superiority |
| Mean Difference (Final Values) |
| 0.03 |
| Standard Deviation |
| 0.94 |
| 2-Sided |
| Superiority |
| Wilcoxon Signed Rank test | 0.0097 | Mean Difference (Final Values) | 0.46 | Standard Deviation | 1.76 | 2-Sided | Superiority |