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| ID | Type | Description | Link |
|---|---|---|---|
| I1R-FW-GLBQ | Other Identifier | Eli Lilly and Company |
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The purposes of this study are to compare how much of LY2409021 enters the bloodstream and how long the body takes to get rid of the drug when different formulations of LY2409021 are given, and when LY2409021 is taken with or without food.
The study will be conducted in 2 cohorts. Each cohort will have 3 study periods consisting of 3 formulations of LY2409021. Participants in each cohort will receive the same all 3 formulations using a randomized sequence crossover design. There is a washout period of at least 14 days between dosing periods.
There will be an interim analysis after Cohort 1 completes study Period 2. Cohort 2 will not begin enrolling until this analysis is complete. The need to enroll Cohort 2 will be determined by the outcome of the interim analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 - LY2409021 reference form | Experimental | A 20 milligram (mg) LY2409021 dose, reference form administered orally in the fasted state |
|
| Cohort 1 - LY2409021 medium test form fed | Experimental | Single 20 mg LY2409021 test form with medium particle size administered orally immediately after ingestion of a standardized high-fat meal |
|
| Cohort 1 - LY2409021 medium test form fasted | Experimental | Single 20 mg LY2409021 test form with medium particle size administered orally in the fasted state |
|
| Cohort 2 - LY2409021 low test form fasted | Experimental | Single 20 mg LY2409021 test form with low particle size administered orally in the fasted state |
|
| Cohort 2 - LY2409021 medium test form fasted | Experimental | Single 20 mg LY2409021 test form with medium particle size administered orally in the fasted state |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2409021 Reference Form | Drug | Administered orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Medium Test Form to Reference Form | AUC from time 0 to infinity (AUC0-∞). | Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose) |
| Pharmacokinetics, Maximum Concentration (Cmax): Medium Test Form to Reference Form | Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Standardized High Fat Meal to Fasting | AUC from time 0 to infinity (AUC0-∞). | Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose) |
| Pharmacokinetics, Maximum Concentration (Cmax): Standardized High Fat Meal to Fasting |
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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 person physician. | Singapore | Singapore |
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| ID | Title | Description |
|---|---|---|
| FG000 | LY2409021 Cohort 1: Sequence 1 | Sequence 1: (Period 1:reference capsules fasting, then Period 2: test-medium tablet fasting, then Period 3: test-medium tablet after high-fat meal). There was a washout period of at least 14 days between interventions. Description of interventions: reference capsules fasting [20-milligram (mg) LY2409021 dose, administered orally, once in fasted state], test-medium tablet fasting (20-mg LY2409021 tablet, medium particle size, administered orally, once in fasted state), and test-medium tablet after high-fat meal (20-mg LY2409021 tablet, medium particle size, administered orally, once, immediately after standardized high-fat meal). |
| FG001 | LY2409021 Cohort 1: Sequence 2 | Sequence 2: (Period 1: test-medium tablet fasting, then Period 2: test-medium tablet after high-fat meal, then Period 3: reference capsules fasting). There was a washout period of at least 14 days between interventions. Description of interventions: reference capsules fasting [20-milligram (mg) LY2409021 dose, administered orally, once in fasted state], test-medium tablet fasting (20-mg LY2409021 tablet, medium particle size, administered orally, once in fasted state), and test-medium tablet after high-fat meal (20-mg LY2409021 tablet, medium particle size, administered orally, once, immediately after standardized high-fat meal). |
| FG002 | LY2409021 Cohort 1: Sequence 3 | Sequence 3: (Period 1:test-medium tablet after high-fat meal, then Period 2: reference capsules fasting, then Period 3: test-medium tablet fasting). There was a washout period of at least 14 days between interventions. Description of interventions: reference capsules fasting [20-milligram (mg) LY2409021 dose, administered orally, once in fasted state], test-medium tablet fasting (20-mg LY2409021 tablet, medium particle size, administered orally, once in fasted state), and test-medium tablet after high-fat meal (20-mg LY2409021 tablet, medium particle size, administered orally, once, immediately after standardized high-fat meal). |
| FG003 | LY2409021 Cohort 2: Sequence 4 | Sequence 4: (Period 1: test-medium tablet fasting then, Period 2: test-high tablet fasting, then Period 3: test-low tablet fasting) There was a washout period of at least 14 days between interventions. Description of interventions: test-low tablet fasting (single 20-mg LY2409021 tablet of a low particle size, administered orally in a fasted state), test-medium tablet fasting (single 20-mg LY2409021 tablet of a medium particle size, administered orally, once in a fasted state), and test-high tablet fasting (single 20-mg LY2409021 tablet of a high particle size administered orally, once in a fasted state). |
| FG004 | LY2409021 Cohort 2: Sequence 5 | Sequence 5: (Period 1: test-high tablet fasting then, Period 2: test-low tablet fasting, then Period 3: test-medium tablet fasting) There was a washout period of at least 14 days between interventions. Description of interventions: test-low tablet fasting (single 20-mg LY2409021 tablet of a low particle size, administered orally in a fasted state), test-medium tablet fasting (single 20-mg LY2409021 tablet of a medium particle size, administered orally, once in a fasted state), and test-high tablet fasting (single 20-mg LY2409021 tablet of a high particle size administered orally, once in a fasted state). |
| FG005 | LY2409021 Cohort 2: Sequence 6 | Sequence 6: (Period1: test-low tablet fasting, then Period 2: test-medium tablet fasting, then Period 3: test-high tablet fasting). There was a washout period of at least 14 days between interventions. Description of interventions: test-low tablet fasting (single 20-mg LY2409021 tablet of a low particle size, administered orally in a fasted state), test-medium tablet fasting (single 20-mg LY2409021 tablet of a medium particle size, administered orally, once in a fasted state), and test-high tablet fasting (single 20-mg LY2409021 tablet of a high particle size administered orally, once in a fasted state). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
|
| |||||||||||||||||||||
| Washout (at Least 14 Days) |
| ||||||||||||||||||||||
| Period 2 |
| ||||||||||||||||||||||
| Washout (at Least 14 Days) |
| ||||||||||||||||||||||
| Period 3 |
|
Randomized participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | LY2409021 Cohort 1 | Participants randomized to 1 of 3 sequences and received a single but different intervention per period: Sequence 1 (reference capsules fasting, then test-medium tablet fasting, then test-medium tablet after high-fat meal), Sequence 2 (test-medium tablet fasting, then test-medium tablet after high-fat meal, then reference capsules fasting), or Sequence 3 (test-medium tablet after high-fat meal, then reference capsules fasting, then test-medium tablet fasting). There was a washout period of at least 14 days between interventions. Description of interventions: reference capsules fasting [20-milligram (mg) LY2409021 dose, administered orally, once in fasted state], test-medium tablet fasting (20-mg LY2409021 tablet, medium particle size, administered orally, once in fasted state), and test-medium tablet after high-fat meal (20-mg LY2409021 tablet, medium particle size, administered orally, once, immediately after standardized high-fat meal). |
| 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, Area Under the Concentration-Time Curve (AUC): Medium Test Form to Reference Form | AUC from time 0 to infinity (AUC0-∞). | Randomized participants in Cohort 1 who received the specified study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour per milliliter (ng*hr/mL) | Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours 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 | LY2409021 Cohort 1 (Reference Capsules Fasted) | A 20-mg LY2409021 dose administered orally, once in a fasted state, during Period 1, 2, or 3. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 13.1 | 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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| Cohort 2 - LY2409021 high test form fasted | Experimental | Single 20 mg LY2409021 test form with high particle size administered orally in the fasted state |
|
| LY2409021 Test-Med Formulation (medium particle size) |
| Drug |
Administered orally |
|
| LY2409021 Test-High Formulation (high particle size) | Drug | Administered orally |
|
| LY2409021 Test-Low Formulation (low particle size) | Drug | Administered orally |
|
| Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose) |
| Pharmacokinetics, Time to Maximum Concentration (Tmax) | Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose) |
| Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Low and High Particle Size to Medium Particle Size | AUC from time 0 to infinity (AUC0-∞). | Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose) |
| Pharmacokinetics, Concentration Maximum (Cmax): Low and High Particle Size to Medium Particle Size | Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose) |
| Physician Decision |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | LY2409021 Cohort 2 | Participants randomized to 1 of 3 sequences and received a single but different intervention per period: Sequence 4 (test-medium tablet fasting then, test-high tablet fasting, then test-low tablet fasting), Sequence 5 (test-high tablet fasting then, test-low tablet fasting, then test-medium tablet fasting), or Sequence 6 (test-low tablet fasting, then test-medium tablet fasting, then test-high tablet fasting). There was a washout period of at least 14 days between interventions. Description of interventions: test-low tablet fasting (single 20-mg LY2409021 tablet of a low particle size, administered orally in a fasted state), test-medium tablet fasting (single 20-mg LY2409021 tablet of a medium particle size, administered orally, once in a fasted state), and test-high tablet fasting (single 20-mg LY2409021 tablet of a high particle size administered orally, once in a fasted state). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
A 20-mg LY2409021 dose administered orally, once in a fasted state, during Period 1, 2, or 3. |
|
|
|
| Primary | Pharmacokinetics, Maximum Concentration (Cmax): Medium Test Form to Reference Form | Randomized participants in Cohort 1 who received the specified study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose) |
|
|
|
|
| Secondary | Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Standardized High Fat Meal to Fasting | AUC from time 0 to infinity (AUC0-∞). | Randomized participants in Cohort 1 who received the specified study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour/milliliter (ng*hr/mL) | Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose) |
|
|
|
|
| Secondary | Pharmacokinetics, Maximum Concentration (Cmax): Standardized High Fat Meal to Fasting | Randomized participants in Cohort 1 who received the specified study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose) |
|
|
|
|
| Secondary | Pharmacokinetics, Time to Maximum Concentration (Tmax) | Randomized participants in Cohorts 1 and 2 who received the specified study drug. | Posted | Median | Full Range | hour (hr) | Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose) |
|
|
|
| Secondary | Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Low and High Particle Size to Medium Particle Size | AUC from time 0 to infinity (AUC0-∞). | Randomized participants in Cohort 2 who received the specified study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour per milliliter (ng*hr/mL) | Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose) |
|
|
|
|
| Secondary | Pharmacokinetics, Concentration Maximum (Cmax): Low and High Particle Size to Medium Particle Size | Randomized participants in Cohort 2 who received the specified study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose) |
|
|
|
|
| 0 |
| 15 |
| 12 |
| 15 |
| EG001 | LY2409021 Cohort 1 (Test-Medium Tablet Fed) | A single 20-mg LY2409021 tablet of a medium particle size administered orally, once, immediately after a standardized high-fat meal, during Period 1, 2, or 3. | 0 | 18 | 17 | 18 |
| EG002 | LY2409021 Cohort 2 (Test-Low Tablet Fasted) | A single 20-mg LY2409021 tablet of a low particle size administered orally, once in a fasted state, during Period 1, 2, or 3. | 0 | 15 | 7 | 15 |
| EG003 | LY2409021 Cohorts 1 and 2 (Test-Medium Tablet Fasted) | A single 20-mg LY2409021 tablet of a medium particle size administered orally, once in a fasted state, during Period 1, 2, or 3. | 0 | 33 | 22 | 33 |
| EG004 | LY2409021 Cohort 2 (Test-High Tablet Fasted) | A single 20-mg LY2409021 tablet of a high particle size administered orally, once in a fasted state, during Period 1, 2, or 3. | 0 | 17 | 9 | 17 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hunger | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vessel puncture site haematoma | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vessel puncture site pain | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vessel puncture site reaction | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vessel puncture site swelling | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Procedural site reaction | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Coagulation time prolonged | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
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| Ratio of geometric least squares means |
| 0.943 |
| 2-Sided |
| 90 |
| 0.905 |
| 0.983 |
AUC0-∞ was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant. |
| Superiority or Other |
| Ratio of geometric least squares means |
| 0.940 |
| 2-Sided |
| 90 |
| 0.891 |
| 0.993 |
Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant. |
| Superiority or Other |