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| ID | Type | Description | Link |
|---|---|---|---|
| H7T-EW-TADQ | Other Identifier | Eli Lilly and Company |
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This study compares the clinical tablet formulation of prasugrel taken orally with an orally disintegrating tablet (ODT) taken orally. The study will evaluate the amount of prasugrel active metabolite circulating in the blood for each treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prasugrel clinical formulation | Active Comparator | A single 5-milligram (mg) prasugrel tablet administered orally by swallowing it whole on 1 occasion. |
|
| Prasugrel (ODT) - on tongue | Experimental | A single 5-mg prasugrel orally disintegrating tablet (ODT) administered orally by placing it on top of the tongue and keeping it there until it disintegrates. |
|
| Prasugrel (ODT) - apple juice | Experimental | A single 5-mg prasugrel ODT administered orally by placing it on top of the tongue followed by drinking approximately 180 milliliters (ml) apple juice within 1 minute after the tablet finishes disintegration. |
|
| Prasugrel (ODT) - chewed | Experimental | A single 5-mg prasugrel ODT administered orally by placing it on top of the tongue, but then chewed and swallowed rather than waiting for it to disintegrate. |
|
| Prasugrel (ODT) - under tongue | Experimental | A single 5-mg prasugrel ODT administered orally by placing it under (rather than on top of) the tongue and keeping it there until it disintegrates. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prasugrel (clinical formulation) | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to the Last Measureable Concentration (AUC[0-tlast]) of Prasugrel's Active Metabolite (PRAS-AM) | Pre-dose up to 8 hours post-dose after each treatment | |
| Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel's Active Metabolite (PRAS-AM) | Pre-dose up to 8 hours post-dose after each treatment | |
| Pharmacokinetics: Time of Maximum Concentration (Tmax) of Prasugrel's Active Metabolite (PRAS-AM) | Pre-dose up to 8 hours post-dose after each treatment |
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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. | Honolulu | Hawaii |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants | Received 5 milligrams (mg) prasugrel as either the clinical tablet or as an orally disintegrating tablet (ODT). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants | Total Number of Study Participants |
| 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 From Time Zero to the Last Measureable Concentration (AUC[0-tlast]) of Prasugrel's Active Metabolite (PRAS-AM) | Pharmacokinetic analyses were conducted on the full analysis set, which included all data from all randomized participants receiving at least 1 dose of prasugrel. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram * hour per milliliter (ng*h/mL) | Pre-dose up to 8 hours post-dose after each treatment |
|
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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 | Clinical Tablet | 5-milligrams (mg) prasugrel clinical tablet swallowed whole with approximately 180 milliliters (ml) water. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vessel puncture site haematoma | General disorders | MedDRA 14.0 | 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 |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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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 (Orally Disintegrating Tablet [ODT]) | Drug | Administered orally |
|
|
| United States |
| years |
|
| 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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| OG002 | ODT on Top of Tongue With Juice Chaser | 5-mg prasugrel ODT placed on the tongue and allowed to disintegrate, followed by approximately 180 milliliters (ml) apple juice chaser. |
| OG003 | ODT Chewed and Swallowed | 5-mg prasugrel ODT chewed and swallowed, no liquid given. |
| OG004 | ODT Placed Under the Tongue | 5-mg prasugrel ODT placed under the tongue and allowed to disintegrate, no liquid given. |
|
|
| Primary | Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel's Active Metabolite (PRAS-AM) | Pharmacokinetic analyses were conducted on the full analysis set, which included all data from all randomized participants receiving at least 1 dose of prasugrel. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Pre-dose up to 8 hours post-dose after each treatment |
|
|
|
| Primary | Pharmacokinetics: Time of Maximum Concentration (Tmax) of Prasugrel's Active Metabolite (PRAS-AM) | Pharmacokinetic analyses were conducted on the full analysis set, which included all data from all randomized participants receiving at least 1 dose of prasugrel. | Posted | Median | Full Range | hours | Pre-dose up to 8 hours post-dose after each treatment |
|
|
|
| 0 |
| 18 |
| 2 |
| 18 |
| EG001 | ODT (Top of Tongue) | 5-mg prasugrel orally disintegrating tablet (ODT) placed on the tongue and allowed to disintegrate, no liquid given. | 0 | 18 | 3 | 18 |
| EG002 | ODT (Juice Chaser) | 5-mg prasugrel ODT placed on the tongue and allowed to disintegrate, followed by approximately 180 milliliters (ml) apple juice chaser. | 0 | 18 | 1 | 18 |
| EG003 | ODT (Chew and Swallow) | 5-mg prasugrel ODT chewed and swallowed, no liquid given. | 0 | 18 | 0 | 18 |
| EG004 | ODT (Under Tongue) | 5-mg prasugrel ODT placed under the tongue and allowed to disintegrate, no liquid given. | 0 | 18 | 0 | 18 |
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |