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| ID | Type | Description | Link |
|---|---|---|---|
| H7T-EW-TAEQ | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| Daiichi Sankyo | INDUSTRY |
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The purpose of this study is to evaluate the amount of drug available in the body when given to healthy participants as two different formulations with or without a meal. In addition, this study will evaluate how much of the drug gets into the blood stream and how long the body takes to get rid of it. Information about any side effects that may occur will also be collected. Each participant will receive a total of five different treatments. Each treatment is given by mouth, once a day. The treatment period lasts for five consecutive days.
The reference formulation is an orally disintegrating tablet without Magnasweet® (ODT1) and the test formulation is an orally disintegrating tablet containing Magnasweet® (ODT2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 mg Prasugrel (ODT1) | Experimental | 5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered once in the fasted state. |
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| 5 mg Prasugrel (ODT2) | Experimental | 5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered once in the fasted state. |
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| 5 mg Prasugrel (ODT2)-Suspension | Experimental | 5 mg Prasugrel as ODT2 formulation dispersed in water administered once, in the fasted state. |
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| 5 mg Prasugrel (ODT2)-Fed | Experimental | 5 mg Prasugrel as ODT2 formulation administered once, following a standardized breakfast. |
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| 2 mg Prasugrel (ODT2) | Experimental | 2 mg Prasugrel as ODT2 formulation administered once in the fasted state. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prasugrel ODT1 - Tablet | Drug | Administered orally as tablet. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test and Reference Formulation | Cmax= maximum concentration measured from predose through 8 hours postdose. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) and the reference formulation is defined as the orally disintegrating tablet without Magnasweet® (ODT1) specific to the 5 milligrams (mg) prasugrel dosing. Pharmacokinetics will measure prasugrel's (LY640315) active metabolite. | Predose through 8 Hours Post Dose |
| Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Reference and Test Formulation | AUC(0-tlast) = area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) and the reference formulation is defined as the orally disintegrating tablet without Magnasweet® (ODT1) specific to the 5 mg prasugrel dosing. Pharmacokinetics will measure prasugrel's active metabolite. | Predose through 8 Hours Post Dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test Formulation in Fasted and Fed State | Cmax= maximum concentration measured from predose through 8 hours postdose. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) specific to the 5 mg prasugrel dosing in the fasted and fed state. Pharmacokinetics will measure prasugrel's active metabolite. |
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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. | Dallas | Texas |
Participants were to be given 5 single doses of prasugrel in 5 different sequences on each of 5 consecutive mornings of treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | Day 1= 5 milligrams (mg) prasugrel without Magnasweet (reference) orally disintegrating tablet (ODT1), given on top of tongue in fasted state (T-Fast); Day 2= 5 mg prasugrel with Magnasweet (test) orally disintegrating tablet (ODT2),T-Fast; Day 3= 5 mg test ODT2, given dispersed in water in fasted state (W-Fast); Day 4= 5 mg test ODT2, given on top of tongue in fed state (T-Fed); Day 5= 2 mg test ODT2, T-Fast |
| FG001 | Sequence 2 | Day 1= 2 mg test ODT2, T-Fast; Day 2= 5 mg ODT1, T-Fast; Day 3= 5 mg test ODT2, T-Fast; Day 4= 5 mg test ODT2, W-Fast; Day 5= 5 mg test ODT2, T-Fed |
| FG002 | Sequence 3 | Day 1= 5 mg test ODT2, T-Fed; Day 2= 2 mg test ODT2, T-Fast; Day 3= 5 mg ODT1, T-Fast; Day 4= 5 mg test ODT2, T-Fast; Day 5= 5 mg test ODT2, W-Fast |
| FG003 | Sequence 4 | Day 1= 5 mg test ODT2, W-Fast; Day 2= 5 mg test ODT2, T-Fed; Day 3= 2 mg test ODT2, T-Fast; Day 4= 5 mg ODT1,T-Fast; Day 5= 5 mg test ODT2, T-Fast |
| FG004 | Sequence 5 | Day 1= 5 mg test ODT2, T-Fast; Day 2= 5 mg test ODT2, W-Fast; Day 3= 5 mg test ODT2, T-Fed; Day 4= 2 mg test ODT2, T-Fast; Day 5= 5 mg ODT1, T-Fast |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment 1 |
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| Treatment 2 |
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| Treatment 3 |
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| Treatment 4 |
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| Treatment 5 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | 5 mg Prasugrel as orally disintegrating tablet without Magnasweet® formulation (ODT1) or orally disintegrating tablet containing Magnasweet® formulation (ODT2) given either on top of tongue or dispersed in water administered in either the fasted or fed state. 2 mg prasugrel ODT2 given on top of tongue in the fasted state. |
| 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: Maximum Concentration (Cmax) of Prasugrel Test and Reference Formulation | Cmax= maximum concentration measured from predose through 8 hours postdose. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) and the reference formulation is defined as the orally disintegrating tablet without Magnasweet® (ODT1) specific to the 5 milligrams (mg) prasugrel dosing. Pharmacokinetics will measure prasugrel's (LY640315) active metabolite. | Pharmacokinetic population consists of all participants who received at least one dose of study drug and have evaluable pharmacokinetic data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Predose through 8 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 | 5 mg Prasugrel (ODT1) | 5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered orally once in the fasted state. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gingival bleeding | Gastrointestinal 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 |
|---|---|
| D000068799 | Prasugrel Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
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| Prasugrel ODT2 - Tablet | Drug | Administered orally as tablet. |
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| Prasugrel ODT2 - Suspension | Drug | Administered orally as suspension. |
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| Predose through 8 Hours Post Dose |
| Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Test Formulation in Fasted and Fed State | AUC(0-tlast) = area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) specific to the 5 mg prasugrel dosing in the fasted and fed state. Pharmacokinetics will measure prasugrel's active metabolite. | Predose through 8 Hours Post Dose |
| United States |
| 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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| 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 | Number | participants |
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| OG001 | 5 mg Prasugrel (ODT2) | 5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered orally once in the fasted state. |
|
|
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| Primary | Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Reference and Test Formulation | AUC(0-tlast) = area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) and the reference formulation is defined as the orally disintegrating tablet without Magnasweet® (ODT1) specific to the 5 mg prasugrel dosing. Pharmacokinetics will measure prasugrel's active metabolite. | Pharmacokinetic population consists of all participants who received at least one dose of study drug and have evaluable pharmacokinetic data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour per milliliter (ng*h/mL) | Predose through 8 Hours Post Dose |
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| Secondary | Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test Formulation in Fasted and Fed State | Cmax= maximum concentration measured from predose through 8 hours postdose. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) specific to the 5 mg prasugrel dosing in the fasted and fed state. Pharmacokinetics will measure prasugrel's active metabolite. | Pharmacokinetic population consists of all participants who received at least one dose of study drug and have evaluable pharmacokinetic data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Predose through 8 Hours Post Dose |
|
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| Secondary | Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Test Formulation in Fasted and Fed State | AUC(0-tlast) = area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) specific to the 5 mg prasugrel dosing in the fasted and fed state. Pharmacokinetics will measure prasugrel's active metabolite. | Pharmacokinetic population consists of all participants who received at least one dose of study drug and have evaluable pharmacokinetic data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour per milliliter (ng*h/mL) | Predose through 8 Hours Post Dose |
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|
| 0 |
| 19 |
| 1 |
| 19 |
| EG001 | 5 mg Prasugrel (ODT2) | 5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered orally once in the fasted state. | 0 | 19 | 0 | 19 |
| EG002 | 5 mg Prasugrel (ODT2)-Suspension | 5 mg Prasugrel as ODT2 formulation dispersed in water administered once, orally as suspension, in the fasted state. | 0 | 20 | 0 | 20 |
| EG003 | 5 mg Prasugrel (ODT2)-Fed | 5 mg Prasugrel as ODT2 formulation administered orally once, following a standardized breakfast. | 0 | 20 | 2 | 20 |
| EG004 | 2 mg Prasugrel (ODT2) | 2 mg Prasugrel as ODT2 formulation administered orally once in the fasted state. | 0 | 19 | 1 | 19 |
| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |