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| ID | Type | Description | Link |
|---|---|---|---|
| I4O-MC-BACG | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to evaluate two different formulations of LY2886721. In addition, this study will determine how much of study drug (LY2886721) gets into the blood steam and how long the body takes to get rid of it after taking each formulation with or without a meal. Information about any side effects that may occur will also be collected. Each participant may be involved in the study for approximately 7 weeks.
This study requires 4 periods. In each period, participants will receive LY2886721 as a tablet or capsule, with or without food and water. There is a 7 day washout between each period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2886721 Capsule (water, fasting) | Experimental | Reference formulation. A single oral dose of 70 milligrams (mg) LY2886721 in a capsule given with water and without a meal in one of four periods. |
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| LY2886721 ODT (no water, fasting) | Experimental | A single oral dose of 70 mg LY2886721 in an orally disintegrating tablet (ODT) given without water and without a meal in one of four periods. |
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| LY2886721 ODT (water, fed) | Experimental | A single oral dose of a 70 mg LY2886721 in an orally disintegrating tablet (ODT) given with water and after a high-fat breakfast in one of four periods. |
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| LY2886721 ODT (water, fasting) | Experimental | A single oral dose of 70 mg LY2886721 in an orally disintegrating tablet (ODT) given with water and without a meal in one of four periods. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2886721 in a Capsule | Drug | Administered orally. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY2886721 | Baseline through 96 hours post-dose | |
| Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of LY2886721 | Baseline through 96 hours post-dose | |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Time Tlast (AUC[0-tlast]) of LY2886721 | Baseline through 96 hours post-dose | |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞] of LY2886721 | Baseline through 96 hours post-dose |
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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. | Madison | Wisconsin | 53704 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Total Study Population | All participants who entered the study and received at least 1 dose of study drug. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| LY2886721 ODT (no Water, Fasting) |
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| First Washout (7 Days) |
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| LY2886721 Capsule (Water, Fasting) |
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| Second Washout (7 Days) |
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| LY2886721 ODT (Water, Fed) |
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| Third Washout (7 Days) |
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| LY2886721 ODT (Water, Fasting) |
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Participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | All participants who entered the study and received at least 1 dose of study drug. |
| Units | Counts |
|---|---|
| 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 | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY2886721 | Participants who received at least one dose of study drug with evaluable LY2886721 Cmax data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms / milliliter (ng/mL) | Baseline through 96 hours post-dose |
|
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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 | LY2886721 Capsule (Water, Fasting) | A single oral dose of 70 milligrams (mg) LY2886721 in a capsule given with water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MedDRA 15.0 | 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 |
|---|---|
| C000596181 | N-(3-(2-amino-4a,5,7,7a-tetrahydro-4H-furo(3,4-d)(1,3)thiazin-7a-yl)-4-fluorophenyl)-5-fluoropicolinamide |
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| LY2886721 in an orally disintegrating tablet (ODT) |
| Drug |
Administered orally. |
|
| United States |
| NOT COMPLETED |
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| NOT 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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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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A single oral dose of 70 mg LY2886721 in an orally disintegrating tablet (ODT) given without water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods. |
| OG002 | LY2886721 ODT (Water, Fed) | A single oral dose of 70 mg LY2886721 in an ODT given with water and after a high-fat breakfast in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods. |
| OG003 | LY2886721 ODT (Water, Fasting) | A single oral dose of 70 mg LY2886721 in an ODT given with water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods. |
|
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| Primary | Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of LY2886721 | Participants who received at least one dose of study drug with evaluable LY2886721 tmax data. | Posted | Median | Full Range | hours | Baseline through 96 hours post-dose |
|
|
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| Primary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Time Tlast (AUC[0-tlast]) of LY2886721 | Participants who received at least one dose of study drug with evaluable LY2886721 AUC (0-tlast) data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms * hour / milliliter | Baseline through 96 hours post-dose |
|
|
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| Primary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞] of LY2886721 | Participants who received at least one dose of study drug with evaluable LY2886721 AUC (0-∞) data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms * hour / milliliter | Baseline through 96 hours post-dose |
|
|
|
| 0 |
| 26 |
| 9 |
| 26 |
| EG001 | LY2886721 ODT (no Water, Fasting) | A single oral dose of 70 mg LY2886721 in an orally disintegrating tablet (ODT) given without water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods. | 0 | 26 | 8 | 26 |
| EG002 | LY2886721 ODT (Water, Fed) | A single oral dose of 70 mg LY2886721 in an ODT given with water and after a high-fat breakfast in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods. | 0 | 25 | 6 | 25 |
| EG003 | LY2886721 ODT (Water, Fasting) | A single oral dose of 70 mg LY2886721 in an ODT given with water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods. | 0 | 24 | 7 | 24 |
| Lip swelling | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Application site discolouration | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Application site erythema | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Application site irritation | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Vessel puncture site haemorrhage | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Folliculitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Animal bite | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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