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| ID | Type | Description | Link |
|---|---|---|---|
| H7T-MC-TAEJ | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| Daiichi Sankyo Co., Ltd. | INDUSTRY |
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The purpose of this study is to measure the exposure to prasugrel's active metabolite and the pharmacodynamic effects of prasugrel treatment in people with Sickle Cell Disease (SCD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prasugrel | Experimental | Participants received a single 10 milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prasugrel | Drug | Oral, daily for 12 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve (AUC) From Time of Dosing Through the Sampling Time of the Last Quantifiable Concentration [AUC(0-tlast)] for Prasugrel's Active Metabolite, R-138727 | The AUC of Prasugrel's active metabolite, R-138727, was calculated through the sampling time of the last quantifiable plasma concentration [AUC(0-tlast)]. Geometric Least Squares (LS) Means were obtained. The log-transformed AUC was analyzed with a mixed effect model with dose, population, dose*population interaction as fixed effects, and participant as a random effect. | Time of dosing up to 8 hours post-dose on Day 1 and Day 12 |
| Maximum Concentration (Cmax) of Prasugrel's Active Metabolite, R-138727 | Cmax was observed from the data and used to calculate Geometric Least Squares (LS) Means. The log-transformed Cmax was analyzed with a mixed effect model with dose, population, dose*population interaction as fixed effects, and participant as a random effect. | Day 1, Day 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Maximum Platelet Aggregation (MPA) to 5 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12 | MPA to 5 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). The LTA results were collected as MPA, for which low values indicate strong platelet inhibition. |
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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. | London | UK | SE 1 1YR |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prasugrel Healthy Participants | Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]). |
| FG001 | Prasugrel Sickle Cell Disease | Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Prasugrel 10 mg SD; 5 mg MD (Healthy) | Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by 5 mg/day (for participants<60 kilograms [kg]) for an additional 11 days (multiple dose [MD]). |
| BG001 | Prasugrel 10 mg SD; 7.5 mg MD (Healthy) |
| 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 | Area Under the Plasma Concentration-Time Curve (AUC) From Time of Dosing Through the Sampling Time of the Last Quantifiable Concentration [AUC(0-tlast)] for Prasugrel's Active Metabolite, R-138727 | The AUC of Prasugrel's active metabolite, R-138727, was calculated through the sampling time of the last quantifiable plasma concentration [AUC(0-tlast)]. Geometric Least Squares (LS) Means were obtained. The log-transformed AUC was analyzed with a mixed effect model with dose, population, dose*population interaction as fixed effects, and participant as a random effect. | All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose. | Posted | Least Squares Mean | 95% Confidence Interval | nanogram*hour per milliliter (ng*h/mL) | Time of dosing up to 8 hours post-dose on Day 1 and Day 12 |
|
Not provided
Not provided
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 | Prasugrel 10/5 mg Healthy Participants | Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by 5 mg/day (for participants<60 kilograms [kg]) for an additional 11 days (multiple dose [MD]). |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sickle cell anaemia with crisis | Congenital, familial and genetic disorders | MedDRA 13.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068799 | Prasugrel Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
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| Baseline, Day 12 |
| Area Under the Plasma Concentration-Time Curve (AUC) From Time of Dosing Through the Sampling Time of the Last Quantifiable Concentration [AUC(0-tlast)] of Prasugrel's Inactive Metabolites, R-95913, R-106583, and R-119251 | AUC was calculated through the sampling time of the last quantifiable plasma concentration [AUC(0-tlast)]. Geometric Least Squares (LS) Means were obtained. The log-transformed AUC was analyzed with a mixed effect model with dose, population, dose*population interaction as fixed effects, and participant as a random effect. | Day 1, Day 12 |
| Change From Baseline in the Residual Platelet Aggregation (RPA) to 5 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12 | RPA is the percentage aggregation as measured by LTA at 6 minutes after the addition of 5 μM ADP. LTA is an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). | Baseline, Day 12 |
| Inhibition of Platelet Aggregation (IPA) to 5 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12 | IPA is calculated as a percent decrease of maximum platelet aggregation (MPA) from baseline using the following formula: ([MPA at baseline - MPA postbaseline] / MPA at baseline) x 100% | Day 12 |
| Change From Baseline in the Maximum Platelet Aggregation (MPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12 | MPA to 20 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). The LTA results were collected as MPA, for which low values indicate strong platelet inhibition. | Baseline, Day 12 |
| Change From Baseline in the Residual Platelet Aggregation (RPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12 | RPA is the percentage aggregation as measured by light transmission aggregometry (LTA) at 6 minutes after the addition of 20 μM ADP. LTA is an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). | Baseline, Day 12 |
| Inhibition of Platelet Aggregation (IPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12 | IPA is calculated as a percent decrease of maximum platelet aggregation (MPA) from baseline using the following formula: ([MPA at baseline - MPA postbaseline] / MPA at baseline) x 100% | Day 12 |
| Maximum Concentration (Cmax) of Prasugrel's Inactive Metabolites, R-95913, R-106583, and R-119251 | Cmax was observed from the data and used to calculate geometric Least Squares (LS) Means. The log-transformed Cmax was analyzed with a mixed effect model with dose, population, dose*population interaction as fixed effects, and participant as a random effect. | Day 1, Day 12 |
| Change From Baseline in the P2Y12 Reaction Units (PRU) Device Reported P2Y12 Percent Inhibition at Day 12 | PRU device reported VerifyNow percent inhibition is reported by Accumetrics VerifyNow™ P2Y12 (VN-P2Y12) assay, a point-of-care device that measures platelet aggregation with single-use, disposable cartridges. | Baseline, Day 12 |
| Change From Baseline in the Platelet Reactivity Index (PRI) of Prasugrel at Day 12 | PRI was calculated by vasodilator-associated phosphoprotein (VASP) phosphorylation assay using flow cytometry (FC) and a VASP assay using enzyme-linked immunosorbent assay (ELISA). The PRI indicates the level of P2Y12 inhibition. A low PRI reflects strong inhibition of P2Y12, whereas a high PRI reflects weak/absent inhibition of P2Y12. | Baseline, Day 12 |
| Change From Baseline in the Area Under the Aggregation Curve at Day 12 | AUC to 20 micromolar (μM) adenosine diphosphate (ADP), 6.5μM ADP, Collagen, and thrombin receptor activator for peptide 6 (TRAP-6) were calculated by whole blood multi-electrode aggregometry (MEA) assay. Platelet aggregation was continuously recorded for 5 minutes and quantified as area under the aggregation curve, measured in aggregation units*minutes (AU*min). | Baseline, Day 12 |
| Change From Baseline in the Percent Aggregation to 20 µM Adenosine Diphosphate (ADP) at Day 12 | Percent aggregation was assessed by Plateletworks® ADP assay, a whole blood-based test of platelet aggregation for the assessment of platelet inhibition. The assay determines the change in single platelet count due to activation and aggregation by ADP and inhibition thereof by antiplatelet agents. | Baseline, Day 12 |
| P2Y12 Reaction Units (PRU)-Derived VerifyNow (VN) Percent Inhibition at Day 12 | PRU-derived VN percent inhibition is calculated as a percent decrease of PRU from baseline using the following formula: ([PRU at baseline - PRU at time of post baseline] / PRU at baseline) x 100% | Day 12 |
| United Kingdom |
Participants received a single 10-mg dose on Day 1 (SD), followed by 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD). |
| BG002 | Prasugrel 10 mg SD; 5 mg MD (Sickle Cell Disease) | Participants received a single 10-mg dose on Day 1 (SD), followed by 5 mg/day (for participants<60 kilograms [kg]) for an additional 11 days (MD). |
| BG003 | Prasugrel 10 mg SD; 7.5 mg MD (Sickle Cell Disease) | Participants received a single 10-mg dose on Day 1 (SD), followed by 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD). |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]). |
| OG001 | Prasugrel Sickle Cell Disease | Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD). |
|
|
|
| Primary | Maximum Concentration (Cmax) of Prasugrel's Active Metabolite, R-138727 | Cmax was observed from the data and used to calculate Geometric Least Squares (LS) Means. The log-transformed Cmax was analyzed with a mixed effect model with dose, population, dose*population interaction as fixed effects, and participant as a random effect. | All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose. | Posted | Least Squares Mean | 95% Confidence Interval | nanogram per milliliter (ng/mL) | Day 1, Day 12 |
|
|
|
|
| Secondary | Change From Baseline in the Maximum Platelet Aggregation (MPA) to 5 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12 | MPA to 5 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). The LTA results were collected as MPA, for which low values indicate strong platelet inhibition. | All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose. | Posted | Mean | Standard Deviation | percent aggregation | Baseline, Day 12 |
|
|
|
|
| Secondary | Area Under the Plasma Concentration-Time Curve (AUC) From Time of Dosing Through the Sampling Time of the Last Quantifiable Concentration [AUC(0-tlast)] of Prasugrel's Inactive Metabolites, R-95913, R-106583, and R-119251 | AUC was calculated through the sampling time of the last quantifiable plasma concentration [AUC(0-tlast)]. Geometric Least Squares (LS) Means were obtained. The log-transformed AUC was analyzed with a mixed effect model with dose, population, dose*population interaction as fixed effects, and participant as a random effect. | All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose. | Posted | Least Squares Mean | 95% Confidence Interval | nanogram*hour per milliliter (ng*h/mL) | Day 1, Day 12 |
|
|
|
|
| Secondary | Change From Baseline in the Residual Platelet Aggregation (RPA) to 5 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12 | RPA is the percentage aggregation as measured by LTA at 6 minutes after the addition of 5 μM ADP. LTA is an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). | All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose. | Posted | Mean | Standard Deviation | percent aggregation | Baseline, Day 12 |
|
|
|
|
| Secondary | Inhibition of Platelet Aggregation (IPA) to 5 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12 | IPA is calculated as a percent decrease of maximum platelet aggregation (MPA) from baseline using the following formula: ([MPA at baseline - MPA postbaseline] / MPA at baseline) x 100% | All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose. | Posted | Mean | Standard Deviation | percent inhibition | Day 12 |
|
|
|
|
| Secondary | Change From Baseline in the Maximum Platelet Aggregation (MPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12 | MPA to 20 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). The LTA results were collected as MPA, for which low values indicate strong platelet inhibition. | All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose. | Posted | Mean | Standard Deviation | percent aggregation | Baseline, Day 12 |
|
|
|
|
| Secondary | Change From Baseline in the Residual Platelet Aggregation (RPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12 | RPA is the percentage aggregation as measured by light transmission aggregometry (LTA) at 6 minutes after the addition of 20 μM ADP. LTA is an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). | All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose. | Posted | Mean | Standard Deviation | percent aggregation | Baseline, Day 12 |
|
|
|
|
| Secondary | Inhibition of Platelet Aggregation (IPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12 | IPA is calculated as a percent decrease of maximum platelet aggregation (MPA) from baseline using the following formula: ([MPA at baseline - MPA postbaseline] / MPA at baseline) x 100% | All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose. | Posted | Mean | Standard Deviation | percent inhibition | Day 12 |
|
|
|
|
| Secondary | Maximum Concentration (Cmax) of Prasugrel's Inactive Metabolites, R-95913, R-106583, and R-119251 | Cmax was observed from the data and used to calculate geometric Least Squares (LS) Means. The log-transformed Cmax was analyzed with a mixed effect model with dose, population, dose*population interaction as fixed effects, and participant as a random effect. | All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose. | Posted | Least Squares Mean | 95% Confidence Interval | nanogram per milliliter (ng/mL) | Day 1, Day 12 |
|
|
|
|
| Secondary | Change From Baseline in the P2Y12 Reaction Units (PRU) Device Reported P2Y12 Percent Inhibition at Day 12 | PRU device reported VerifyNow percent inhibition is reported by Accumetrics VerifyNow™ P2Y12 (VN-P2Y12) assay, a point-of-care device that measures platelet aggregation with single-use, disposable cartridges. | All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose. | Posted | Mean | Standard Deviation | percent inhibition | Baseline, Day 12 |
|
|
|
|
| Secondary | Change From Baseline in the Platelet Reactivity Index (PRI) of Prasugrel at Day 12 | PRI was calculated by vasodilator-associated phosphoprotein (VASP) phosphorylation assay using flow cytometry (FC) and a VASP assay using enzyme-linked immunosorbent assay (ELISA). The PRI indicates the level of P2Y12 inhibition. A low PRI reflects strong inhibition of P2Y12, whereas a high PRI reflects weak/absent inhibition of P2Y12. | All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose. | Posted | Mean | Standard Deviation | percentage PRI | Baseline, Day 12 |
|
|
|
|
| Secondary | Change From Baseline in the Area Under the Aggregation Curve at Day 12 | AUC to 20 micromolar (μM) adenosine diphosphate (ADP), 6.5μM ADP, Collagen, and thrombin receptor activator for peptide 6 (TRAP-6) were calculated by whole blood multi-electrode aggregometry (MEA) assay. Platelet aggregation was continuously recorded for 5 minutes and quantified as area under the aggregation curve, measured in aggregation units*minutes (AU*min). | All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose. | Posted | Mean | Standard Deviation | aggregation units*minutes (AU*min) | Baseline, Day 12 |
|
|
|
|
| Secondary | Change From Baseline in the Percent Aggregation to 20 µM Adenosine Diphosphate (ADP) at Day 12 | Percent aggregation was assessed by Plateletworks® ADP assay, a whole blood-based test of platelet aggregation for the assessment of platelet inhibition. The assay determines the change in single platelet count due to activation and aggregation by ADP and inhibition thereof by antiplatelet agents. | All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose. | Posted | Mean | Standard Deviation | percent aggregation | Baseline, Day 12 |
|
|
|
|
| Secondary | P2Y12 Reaction Units (PRU)-Derived VerifyNow (VN) Percent Inhibition at Day 12 | PRU-derived VN percent inhibition is calculated as a percent decrease of PRU from baseline using the following formula: ([PRU at baseline - PRU at time of post baseline] / PRU at baseline) x 100% | All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose. | Posted | Mean | Standard Deviation | percent inhibition | Day 12 |
|
|
|
|
| 0 |
| 4 |
| 3 |
| 4 |
| EG001 | Prasugrel 10/7.5 mg Healthy Participants | Participants received a single 10-mg dose on Day 1 (SD), followed by 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD). | 0 | 9 | 5 | 9 |
| EG002 | All Prasugrel Healthy Participants | Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD). | 0 | 13 | 8 | 13 |
| EG003 | Prasugrel 10/5 mg Sickle Cell Disease | Participants received a single 10-mg dose on Day 1 (SD), followed by 5 mg/day (for participants<60 kg) for an additional 11 days (MD). | 0 | 4 | 3 | 4 |
| EG004 | Prasugrel 10/7.5 mg Sickle Cell Disease | Participants received a single 10-mg dose on Day 1 (SD), followed by 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD). | 0 | 9 | 7 | 9 |
| EG005 | All Prasugrel Sickle Cell Disease Participants | Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD). | 0 | 13 | 10 | 13 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Ulcer | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
Not provided
| 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 |
| 5 mg MD (N=4, 4) |
|
| Mixed Models Analysis |
Log(Cmax) = Participant + Population + Dose + Population*Dose + Random Error |
| Ratio of Geometric LS Means, SCD:Healthy |
| 0.612 |
| 2-Sided |
| 90 |
| 0.436 |
| 0.860 |
This is the estimated value for the 7.5 mg MD. |
| No |
| Superiority or Other |
| Mixed Models Analysis | Log(Cmax) = Participant + Population + Dose + Population*Dose + Random Error | Geometric LS Means, SCD:Healthy | 1.03 | 2-Sided | 90 | 0.625 | 1.68 | This is the estimated value for 5 mg MD. | No | Superiority or Other |
| 5 mg MD for R-95913 (N=4, 4) |
|
| 10 mg SD (overall) for R-106583 |
|
| 7.5 mg MD for R-106583 (N=9, 8) |
|
| 5 mg MD for R-106583 (N=4, 4) |
|
| 10 mg SD (overall) for R-119251 |
|
| 7.5 mg MD for R-119251 (N=9, 8) |
|
| 5 mg MD for R-119251 (N=4, 4) |
|
| Mixed Models Analysis |
Log(AUC) = Participant + Population + Dose + Population*Dose + Random Error |
| Ratio of Geometric LS Means, SCD:Healthy |
| 1.44 |
| 2-Sided |
| 90 |
| 1.06 |
| 1.94 |
This is the estimated value for 7.5 mg MD for the R-95913 metabolite. |
| No |
| Superiority or Other |
| Mixed Models Analysis | Log(AUC) = Participant + Population + Dose + Population*Dose + Random Error | Ratio of Geometric LS Means, SCD:Healthy | 1.43 | 2-Sided | 90 | 0.918 | 2.21 | This is the estimated value for 5 mg MD for the R-95913 metabolite. | No | Superiority or Other |
| Mixed Models Analysis | Log(AUC) = Participant + Population + Dose + Population*Dose + Random Error | Ratio of Geometric LS Means, SCD:Healthy | 0.971 | 2-Sided | 90 | 0.742 | 1.27 | This is the estimated value for the 10 mg SD (overall) for the R-106583 metabolite. | No | Superiority or Other |
| Mixed Models Analysis | Log(AUC) = Participant + Population + Dose + Population*Dose + Random Error | Ratio of Geometric LS Means, SCD:Healthy | 0.815 | 2-Sided | 90 | 0.633 | 1.05 | This is the estimated value for the 7.5 mg MD for the R-106583 metabolite. | No | Superiority or Other |
| Mixed Models Analysis | Log(AUC) = Participant + Population + Dose + Population*Dose + Random Error | Ratio of Geometric LS Means, SCD:Healthy | 0.952 | 2-Sided | 90 | 0.658 | 1.38 | This is the estimated value for the 5 mg MD for the R-106583 metabolite. | No | Superiority or Other |
| Mixed Models Analysis | Log(AUC) = Participant + Population + Dose + Population*Dose + Random Error | Ratio of Geometric LS Means, SCD:Healthy | 1.17 | 2-Sided | 90 | 0.833 | 1.65 | This is the estimated value for 10 mg SD (overall) for the R-119251 metabolite. | No | Superiority or Other |
| Mixed Models Analysis | Log(AUC) = Participant + Population + Dose + Population*Dose + Random Error | Ratio of Geometric LS Means, SCD:Healthy | 1.07 | 2-Sided | 90 | 0.779 | 1.48 | This is the estimated value for 7.5 mg MD for the R-119251 metabolite. | No | Superiority or Other |
| Mixed Models Analysis | Log(AUC) = Participant + Population + Dose + Population*Dose + Random Error | Ratio of Geometric LS Means, SCD:Healthy | 0.813 | 2-Sided | 95 | 0.510 | 1.30 | This is the estimated value for 5 mg MD for the R-119251 metabolite. | No | Superiority or Other |
| 5 mg MD for R-95913 (N=4, 4) |
|
| 10 mg SD (overall) for R-106583 |
|
| 7.5 mg MD for R-106583 (N=9, 8) |
|
| 5 mg MD for R-106583 (N=4, 4) |
|
| 10 mg SD (overall) for R-119251 |
|
| 7.5 mg MD for R-119251 (N=9, 8) |
|
| 5 mg MD for R-119251 (N=4, 4) |
|
| Mixed Models Analysis |
Log(Cmax) = Participant + Population + Dose + Population*Dose + Random Error |
| Ratio of Geometric LS Means, SCD:Healthy |
| 1.09 |
| 2-Sided |
| 90 |
| 0.751 |
| 1.58 |
This is the estimated value for 7.5 mg MD for the R-95913 metabolite. |
| No |
| Superiority or Other |
| Mixed Models Analysis | Log(Cmax) = Participant + Population + Dose + Population*Dose + Random Error | Ratio of Geometric LS Means, SCD:Healthy | 1.87 | 2-Sided | 90 | 1.09 | 3.20 | This is the estimated value for 5 mg MD for the R-95913 metabolite. | No | Superiority or Other |
| Mixed Models Analysis | Log(Cmax) = Participant + Population + Dose + Population*Dose + Random Error | Ratio of Geometric LS Means, SCD:Healthy | 0.873 | 2-Sided | 90 | 0.660 | 1.15 | This is the estimated value for 10 mg SD (overall) for the R-106583 metabolite. | No | Superiority or Other |
| Mixed Models Analysis | Log(Cmax) = Participant + Population + Dose + Population*Dose + Random Error | Ratio of Geometric LS Means, SCD:Healthy | 0.681 | 2-Sided | 90 | 0.524 | 0.886 | This is the estimated value for 7.5 mg MD for the R-106583 metabolite. | No | Superiority or Other |
| Mixed Models Analysis | Log(Cmax) = Participant + Population + Dose + Population*Dose + Random Error | Ratio of Geometric LS Means, SCD:Healthy | 0.898 | 2-Sided | 90 | 0.612 | 1.32 | This is the estimated value for 5 mg MD for the R-106583 metabolite. | No | Superiority or Other |
| Mixed Models Analysis | Log(Cmax) = Participant + Population + Dose + Population*Dose + Random Error | Ratio of Geometric LS Means, SCD:Healthy | 1.06 | 2-Sided | 90 | 0.773 | 1.46 | This is the estimated value for 10 mg SD (overall) for the R-119251 metabolite. | No | Superiority or Other |
| Mixed Models Analysis | Log(Cmax) = Participant + Population + Dose + Population*Dose + Random Error | Ratio of Geometric LS Means, SCD:Healthy | 0.785 | 2-Sided | 90 | 0.582 | 1.06 | This is the estimated value for 7.5 mg MD for the R-119251 metabolite. | No | Superiority or Other |
| Mixed Models Analysis | Log(Cmax) = Participant + Population + Dose + Population*Dose + Random Error | Ratio of Geometric LS Means, SCD:Healthy | 1.00 | 2-Sided | 90 | 0.648 | 1.55 | This is the estimated value for 5 mg MD for the R-119251 metabolite. | No | Superiority or Other |
| ELISA at Baseline (Day 1), (N=11, 13) |
|
| ELISA, Day 12 Change (N=11, 12) |
|
| 0.679 |
This is the p-value for PRI by ELISA. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment*Population + Random Error |
| 95 |
| No |
| Superiority or Other |
| AU*min to 20 µM ADP at Baseline (Day 1) |
|
| AU*min to 20 µM ADP, Day 12 Change (N=13, 11) |
|
| AU*min to Collagen at Baseline (Day 1) |
|
| AU*min to Collagen, Day 12 Change (N=13, 11) |
|
| AU*min to TRAP-6 at Baseline (Day 1) |
|
| AU*min to TRAP-6, Day 12 Change (N=13, 11) |
|
| 0.288 |
This is the p-value for AU*min to 20 µM ADP. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment*Population + Random Error. |
| 95 |
| No |
| Superiority or Other |
| ANCOVA | 0.095 | This is the p-value for AU*min to Collagen. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment*Population + Random Error. | 95 | No | Superiority or Other |
| ANCOVA | 0.086 | This is the p-value for AU*min to TRAP-6. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment*Population + Random Error. | 95 | No | Superiority or Other |