Trial Outcomes & Findings for An Assessment of Prasugrel on Healthy Adults and Sickle Cell Adults (NCT NCT01178099)
NCT ID: NCT01178099
Last Updated: 2012-02-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
Time of dosing up to 8 hours post-dose on Day 1 and Day 12
Results posted on
2012-02-15
Participant Flow
Participant milestones
| Measure |
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 \[MD\]).
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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 \[MD\]).
|
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).
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
An Assessment of Prasugrel on Healthy Adults and Sickle Cell Adults
Baseline characteristics by cohort
| Measure |
Prasugrel 10 mg SD; 5 mg MD (Healthy)
n=4 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 \[MD\]).
|
Prasugrel 10 mg SD; 7.5 mg MD (Healthy)
n=9 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).
|
Prasugrel 10 mg SD; 5 mg MD (Sickle Cell Disease)
n=4 Participants
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).
|
Prasugrel 10 mg SD; 7.5 mg MD (Sickle Cell Disease)
n=9 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).
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
24.8 years
STANDARD_DEVIATION 3.0 • n=99 Participants
|
27.6 years
STANDARD_DEVIATION 6.5 • n=107 Participants
|
28.0 years
STANDARD_DEVIATION 14.8 • n=206 Participants
|
29.6 years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
27.9 years
STANDARD_DEVIATION 7.6 • n=31 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
24 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United Kingdom
|
4 participants
n=99 Participants
|
9 participants
n=107 Participants
|
4 participants
n=206 Participants
|
9 participants
n=7 Participants
|
26 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Time of dosing up to 8 hours post-dose on Day 1 and Day 12Population: 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.
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.
Outcome measures
| Measure |
Prasugrel Healthy Participants
n=13 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 \[MD\]).
|
Prasugrel Sickle Cell Disease
n=12 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).
|
|---|---|---|
|
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
10 mg SD (overall)
|
68.2 nanogram*hour per milliliter (ng*h/mL)
Interval 57.9 to 80.5
|
71.5 nanogram*hour per milliliter (ng*h/mL)
Interval 60.5 to 84.6
|
|
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
7.5 mg MD (N=9, 8)
|
50.4 nanogram*hour per milliliter (ng*h/mL)
Interval 42.0 to 60.5
|
45.2 nanogram*hour per milliliter (ng*h/mL)
Interval 37.2 to 54.8
|
|
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
5 mg MD (N=4, 4)
|
39.8 nanogram*hour per milliliter (ng*h/mL)
Interval 30.3 to 52.3
|
36.0 nanogram*hour per milliliter (ng*h/mL)
Interval 27.4 to 47.4
|
PRIMARY outcome
Timeframe: Day 1, Day 12Population: 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.
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.
Outcome measures
| Measure |
Prasugrel Healthy Participants
n=13 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 \[MD\]).
|
Prasugrel Sickle Cell Disease
n=12 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).
|
|---|---|---|
|
Maximum Concentration (Cmax) of Prasugrel's Active Metabolite, R-138727
10 mg SD (overall)
|
67.9 nanogram per milliliter (ng/mL)
Interval 52.8 to 87.4
|
64.7 nanogram per milliliter (ng/mL)
Interval 50.1 to 83.7
|
|
Maximum Concentration (Cmax) of Prasugrel's Active Metabolite, R-138727
7.5 mg MD (N=9, 8)
|
62.5 nanogram per milliliter (ng/mL)
Interval 47.2 to 82.7
|
38.2 nanogram per milliliter (ng/mL)
Interval 28.4 to 51.5
|
|
Maximum Concentration (Cmax) of Prasugrel's Active Metabolite, R-138727
5 mg MD (N=4, 4)
|
40.9 nanogram per milliliter (ng/mL)
Interval 26.9 to 62.3
|
42.0 nanogram per milliliter (ng/mL)
Interval 27.6 to 63.9
|
SECONDARY outcome
Timeframe: Baseline, Day 12Population: 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.
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.
Outcome measures
| Measure |
Prasugrel Healthy Participants
n=13 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 \[MD\]).
|
Prasugrel Sickle Cell Disease
n=11 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).
|
|---|---|---|
|
Change From Baseline in the Maximum Platelet Aggregation (MPA) to 5 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12
Baseline (Day 1)
|
80.4 percent aggregation
Standard Deviation 23.2
|
73.1 percent aggregation
Standard Deviation 14.4
|
|
Change From Baseline in the Maximum Platelet Aggregation (MPA) to 5 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12
Change from Baseline at Day 12 (N=12, 7)
|
-49.9 percent aggregation
Standard Deviation 18.7
|
-33.4 percent aggregation
Standard Deviation 30.0
|
SECONDARY outcome
Timeframe: Day 1, Day 12Population: 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.
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.
Outcome measures
| Measure |
Prasugrel Healthy Participants
n=13 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 \[MD\]).
|
Prasugrel Sickle Cell Disease
n=12 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).
|
|---|---|---|
|
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
10 mg SD (overall) for R-95913
|
52.8 nanogram*hour per milliliter (ng*h/mL)
Interval 42.1 to 66.1
|
80.2 nanogram*hour per milliliter (ng*h/mL)
Interval 63.8 to 101.0
|
|
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
7.5 mg MD for R-95913 (N=9, 8)
|
49.4 nanogram*hour per milliliter (ng*h/mL)
Interval 38.5 to 63.4
|
70.9 nanogram*hour per milliliter (ng*h/mL)
Interval 54.4 to 92.4
|
|
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
5 mg MD for R-95913 (N=4, 4)
|
33.6 nanogram*hour per milliliter (ng*h/mL)
Interval 23.1 to 48.9
|
47.9 nanogram*hour per milliliter (ng*h/mL)
Interval 32.9 to 92.4
|
|
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
10 mg SD (overall) for R-106583
|
248 nanogram*hour per milliliter (ng*h/mL)
Interval 206.0 to 300.0
|
241 nanogram*hour per milliliter (ng*h/mL)
Interval 199.0 to 292.0
|
|
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
7.5 mg MD for R-106583 (N=9, 8)
|
213 nanogram*hour per milliliter (ng*h/mL)
Interval 173.0 to 263.0
|
174 nanogram*hour per milliliter (ng*h/mL)
Interval 139.0 to 217.0
|
|
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
5 mg MD for R-106583 (N=4, 4)
|
151 nanogram*hour per milliliter (ng*h/mL)
Interval 110.0 to 207.0
|
144 nanogram*hour per milliliter (ng*h/mL)
Interval 105.0 to 197.0
|
|
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
10 mg SD (overall) for R-119251
|
32.7 nanogram*hour per milliliter (ng*h/mL)
Interval 25.8 to 41.6
|
38.3 nanogram*hour per milliliter (ng*h/mL)
Interval 30.1 to 48.9
|
|
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
7.5 mg MD for R-119251 (N=9, 8)
|
22.2 nanogram*hour per milliliter (ng*h/mL)
Interval 17.1 to 29.0
|
23.8 nanogram*hour per milliliter (ng*h/mL)
Interval 18.0 to 31.6
|
|
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
5 mg MD for R-119251 (N=4, 4)
|
20.1 nanogram*hour per milliliter (ng*h/mL)
Interval 13.5 to 29.9
|
16.3 nanogram*hour per milliliter (ng*h/mL)
Interval 11.0 to 24.3
|
SECONDARY outcome
Timeframe: Baseline, Day 12Population: 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.
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).
Outcome measures
| Measure |
Prasugrel Healthy Participants
n=13 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 \[MD\]).
|
Prasugrel Sickle Cell Disease
n=11 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).
|
|---|---|---|
|
Change From Baseline in the Residual Platelet Aggregation (RPA) to 5 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12
Baseline (Day 1)
|
76.9 percent aggregation
Standard Deviation 29.1
|
72.2 percent aggregation
Standard Deviation 14.1
|
|
Change From Baseline in the Residual Platelet Aggregation (RPA) to 5 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12
Change from Baseline at Day 12 (N=12, 7)
|
-70.3 percent aggregation
Standard Deviation 27.4
|
-47.3 percent aggregation
Standard Deviation 35.6
|
SECONDARY outcome
Timeframe: Day 12Population: 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.
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%
Outcome measures
| Measure |
Prasugrel Healthy Participants
n=12 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 \[MD\]).
|
Prasugrel Sickle Cell Disease
n=7 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).
|
|---|---|---|
|
Inhibition of Platelet Aggregation (IPA) to 5 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12
|
61.2 percent inhibition
Standard Deviation 13.1
|
41.7 percent inhibition
Standard Deviation 47.3
|
SECONDARY outcome
Timeframe: Baseline, Day 12Population: 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.
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.
Outcome measures
| Measure |
Prasugrel Healthy Participants
n=13 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 \[MD\]).
|
Prasugrel Sickle Cell Disease
n=11 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).
|
|---|---|---|
|
Change From Baseline in the Maximum Platelet Aggregation (MPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12
Baseline (Day 1)
|
85.0 percent aggregation
Standard Deviation 15.9
|
73.4 percent aggregation
Standard Deviation 12.9
|
|
Change From Baseline in the Maximum Platelet Aggregation (MPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12
Change from Baseline at Day 12 (N=12, 9)
|
-43.3 percent aggregation
Standard Deviation 11.7
|
-30.9 percent aggregation
Standard Deviation 22.6
|
SECONDARY outcome
Timeframe: Baseline, Day 12Population: 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.
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).
Outcome measures
| Measure |
Prasugrel Healthy Participants
n=13 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 \[MD\]).
|
Prasugrel Sickle Cell Disease
n=11 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).
|
|---|---|---|
|
Change From Baseline in the Residual Platelet Aggregation (RPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12
Baseline (Day 1)
|
84.1 percent aggregation
Standard Deviation 16.7
|
72.2 percent aggregation
Standard Deviation 12.4
|
|
Change From Baseline in the Residual Platelet Aggregation (RPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12
Change from Baseline at Day 12 (N=12, 8)
|
-67.0 percent aggregation
Standard Deviation 18.1
|
-45.5 percent aggregation
Standard Deviation 32.7
|
SECONDARY outcome
Timeframe: Day 12Population: 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.
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%
Outcome measures
| Measure |
Prasugrel Healthy Participants
n=12 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 \[MD\]).
|
Prasugrel Sickle Cell Disease
n=9 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).
|
|---|---|---|
|
Inhibition of Platelet Aggregation (IPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12
|
52.6 percent inhibition
Standard Deviation 13.5
|
38.5 percent inhibition
Standard Deviation 32.2
|
SECONDARY outcome
Timeframe: Day 1, Day 12Population: 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.
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.
Outcome measures
| Measure |
Prasugrel Healthy Participants
n=13 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 \[MD\]).
|
Prasugrel Sickle Cell Disease
n=12 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).
|
|---|---|---|
|
Maximum Concentration (Cmax) of Prasugrel's Inactive Metabolites, R-95913, R-106583, and R-119251
10 mg SD (overall) for R-95913
|
30.2 nanogram per milliliter (ng/mL)
Interval 23.0 to 39.8
|
45.4 nanogram per milliliter (ng/mL)
Interval 34.3 to 60.1
|
|
Maximum Concentration (Cmax) of Prasugrel's Inactive Metabolites, R-95913, R-106583, and R-119251
7.5 mg MD for R-95913 (N=9, 8)
|
33.4 nanogram per milliliter (ng/mL)
Interval 24.6 to 45.3
|
36.3 nanogram per milliliter (ng/mL)
Interval 26.3 to 50.2
|
|
Maximum Concentration (Cmax) of Prasugrel's Inactive Metabolites, R-95913, R-106583, and R-119251
5 mg MD for R-95913 (N=4, 4)
|
18.4 nanogram per milliliter (ng/mL)
Interval 11.7 to 29.1
|
34.4 nanogram per milliliter (ng/mL)
Interval 21.8 to 54.4
|
|
Maximum Concentration (Cmax) of Prasugrel's Inactive Metabolites, R-95913, R-106583, and R-119251
10 mg SD (overall) for R-106583
|
68.5 nanogram per milliliter (ng/mL)
Interval 56.3 to 83.3
|
59.8 nanogram per milliliter (ng/mL)
Interval 49.0 to 73.0
|
|
Maximum Concentration (Cmax) of Prasugrel's Inactive Metabolites, R-95913, R-106583, and R-119251
7.5 mg MD for R-106583 (N=9, 8)
|
56.8 nanogram per milliliter (ng/mL)
Interval 45.7 to 70.6
|
38.7 nanogram per milliliter (ng/mL)
Interval 30.8 to 48.7
|
|
Maximum Concentration (Cmax) of Prasugrel's Inactive Metabolites, R-95913, R-106583, and R-119251
5 mg MD for R-106583 (N=4, 4)
|
38.7 nanogram per milliliter (ng/mL)
Interval 28.0 to 53.7
|
34.8 nanogram per milliliter (ng/mL)
Interval 25.1 to 48.2
|
|
Maximum Concentration (Cmax) of Prasugrel's Inactive Metabolites, R-95913, R-106583, and R-119251
10 mg SD (overall) for R-119251
|
24.9 nanogram per milliliter (ng/mL)
Interval 20.0 to 31.1
|
26.5 nanogram per milliliter (ng/mL)
Interval 21.1 to 33.2
|
|
Maximum Concentration (Cmax) of Prasugrel's Inactive Metabolites, R-95913, R-106583, and R-119251
7.5 mg MD for R-119251 (N=9, 8)
|
15.5 nanogram per milliliter (ng/mL)
Interval 10.7 to 22.4
|
15.9 nanogram per milliliter (ng/mL)
Interval 12.2 to 20.7
|
|
Maximum Concentration (Cmax) of Prasugrel's Inactive Metabolites, R-95913, R-106583, and R-119251
5 mg MD for R-119251 (N=4, 4)
|
20.3 nanogram per milliliter (ng/mL)
Interval 15.8 to 25.9
|
15.5 nanogram per milliliter (ng/mL)
Interval 10.7 to 22.4
|
SECONDARY outcome
Timeframe: Baseline, Day 12Population: 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.
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.
Outcome measures
| Measure |
Prasugrel Healthy Participants
n=11 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 \[MD\]).
|
Prasugrel Sickle Cell Disease
n=11 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).
|
|---|---|---|
|
Change From Baseline in the P2Y12 Reaction Units (PRU) Device Reported P2Y12 Percent Inhibition at Day 12
Baseline (Day 1)
|
12.0 percent inhibition
Standard Deviation 11.0
|
1.0 percent inhibition
Standard Deviation 2.2
|
|
Change From Baseline in the P2Y12 Reaction Units (PRU) Device Reported P2Y12 Percent Inhibition at Day 12
Change from Baseline at Day 12 (N=11, 10)
|
60.1 percent inhibition
Standard Deviation 19.6
|
47.9 percent inhibition
Standard Deviation 17.0
|
SECONDARY outcome
Timeframe: Baseline, Day 12Population: 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.
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.
Outcome measures
| Measure |
Prasugrel Healthy Participants
n=13 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 \[MD\]).
|
Prasugrel Sickle Cell Disease
n=13 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).
|
|---|---|---|
|
Change From Baseline in the Platelet Reactivity Index (PRI) of Prasugrel at Day 12
Flow Cytometry at Baseline (Day 1), (N=12, 8)
|
78.91 percentage PRI
Standard Deviation 10.03
|
59.36 percentage PRI
Standard Deviation 23.31
|
|
Change From Baseline in the Platelet Reactivity Index (PRI) of Prasugrel at Day 12
Flow Cytometry, Day 12 Change, (N=12, 8)
|
-49.883 percentage PRI
Standard Deviation 22.004
|
-46.000 percentage PRI
Standard Deviation 27.395
|
|
Change From Baseline in the Platelet Reactivity Index (PRI) of Prasugrel at Day 12
ELISA at Baseline (Day 1), (N=11, 13)
|
94.70 percentage PRI
Standard Deviation 2.39
|
92.03 percentage PRI
Standard Deviation 5.65
|
|
Change From Baseline in the Platelet Reactivity Index (PRI) of Prasugrel at Day 12
ELISA, Day 12 Change (N=11, 12)
|
-70.436 percentage PRI
Standard Deviation 17.160
|
-68.117 percentage PRI
Standard Deviation 12.856
|
SECONDARY outcome
Timeframe: Baseline, Day 12Population: 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.
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).
Outcome measures
| Measure |
Prasugrel Healthy Participants
n=13 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 \[MD\]).
|
Prasugrel Sickle Cell Disease
n=12 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).
|
|---|---|---|
|
Change From Baseline in the Area Under the Aggregation Curve at Day 12
AU*min to 6.5 µM ADP at Baseline (Day 1)
|
76.5 aggregation units*minutes (AU*min)
Standard Deviation 13.2
|
106.4 aggregation units*minutes (AU*min)
Standard Deviation 27.9
|
|
Change From Baseline in the Area Under the Aggregation Curve at Day 12
AU*min to 6.5 µM ADP, Day 12 Change (N=13, 11)
|
-49.538 aggregation units*minutes (AU*min)
Standard Deviation 17.145
|
-63.182 aggregation units*minutes (AU*min)
Standard Deviation 24.153
|
|
Change From Baseline in the Area Under the Aggregation Curve at Day 12
AU*min to 20 µM ADP at Baseline (Day 1)
|
85.0 aggregation units*minutes (AU*min)
Standard Deviation 19.0
|
108.1 aggregation units*minutes (AU*min)
Standard Deviation 27.7
|
|
Change From Baseline in the Area Under the Aggregation Curve at Day 12
AU*min to 20 µM ADP, Day 12 Change (N=13, 11)
|
-54.077 aggregation units*minutes (AU*min)
Standard Deviation 22.552
|
-66.182 aggregation units*minutes (AU*min)
Standard Deviation 26.084
|
|
Change From Baseline in the Area Under the Aggregation Curve at Day 12
AU*min to Collagen at Baseline (Day 1)
|
85.5 aggregation units*minutes (AU*min)
Standard Deviation 12.7
|
102.3 aggregation units*minutes (AU*min)
Standard Deviation 25.4
|
|
Change From Baseline in the Area Under the Aggregation Curve at Day 12
AU*min to Collagen, Day 12 Change (N=13, 11)
|
-7.692 aggregation units*minutes (AU*min)
Standard Deviation 11.707
|
-3.000 aggregation units*minutes (AU*min)
Standard Deviation 26.038
|
|
Change From Baseline in the Area Under the Aggregation Curve at Day 12
AU*min to TRAP-6 at Baseline (Day 1)
|
120.2 aggregation units*minutes (AU*min)
Standard Deviation 18.6
|
131.5 aggregation units*minutes (AU*min)
Standard Deviation 30.7
|
|
Change From Baseline in the Area Under the Aggregation Curve at Day 12
AU*min to TRAP-6, Day 12 Change (N=13, 11)
|
-7.846 aggregation units*minutes (AU*min)
Standard Deviation 20.136
|
-2.818 aggregation units*minutes (AU*min)
Standard Deviation 33.045
|
SECONDARY outcome
Timeframe: Baseline, Day 12Population: 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.
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.
Outcome measures
| Measure |
Prasugrel Healthy Participants
n=13 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 \[MD\]).
|
Prasugrel Sickle Cell Disease
n=12 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).
|
|---|---|---|
|
Change From Baseline in the Percent Aggregation to 20 µM Adenosine Diphosphate (ADP) at Day 12
Baseline (Day 1)
|
91.3 percent aggregation
Standard Deviation 9.8
|
74.0 percent aggregation
Standard Deviation 30.0
|
|
Change From Baseline in the Percent Aggregation to 20 µM Adenosine Diphosphate (ADP) at Day 12
Change from Baseline at Day 12 (N=12, 10)
|
-53.0 percent aggregation
Standard Deviation 16.4
|
-46.7 percent aggregation
Standard Deviation 44.8
|
SECONDARY outcome
Timeframe: Day 12Population: 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.
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%
Outcome measures
| Measure |
Prasugrel Healthy Participants
n=11 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 \[MD\]).
|
Prasugrel Sickle Cell Disease
n=10 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).
|
|---|---|---|
|
P2Y12 Reaction Units (PRU)-Derived VerifyNow (VN) Percent Inhibition at Day 12
|
65.8 percent inhibition
Standard Deviation 23.4
|
47.8 percent inhibition
Standard Deviation 18.6
|
Adverse Events
Prasugrel 10/5 mg Healthy Participants
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Prasugrel 10/7.5 mg Healthy Participants
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
All Prasugrel Healthy Participants
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Prasugrel 10/5 mg Sickle Cell Disease
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Prasugrel 10/7.5 mg Sickle Cell Disease
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
All Prasugrel Sickle Cell Disease Participants
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Prasugrel 10/5 mg Healthy Participants
n=4 participants at risk
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 \[MD\]).
|
Prasugrel 10/7.5 mg Healthy Participants
n=9 participants at risk
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).
|
All Prasugrel Healthy Participants
n=13 participants at risk
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).
|
Prasugrel 10/5 mg Sickle Cell Disease
n=4 participants at risk
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).
|
Prasugrel 10/7.5 mg Sickle Cell Disease
n=9 participants at risk
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).
|
All Prasugrel Sickle Cell Disease Participants
n=13 participants at risk
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).
|
|---|---|---|---|---|---|---|
|
General disorders
Ulcer
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/13
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
22.2%
2/9 • Number of events 2
|
15.4%
2/13 • Number of events 2
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/13
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/13
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
7.7%
1/13 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/13
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
7.7%
1/13 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/13
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/13
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/13
|
50.0%
2/4 • Number of events 2
|
0.00%
0/9
|
15.4%
2/13 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Headache
|
75.0%
3/4 • Number of events 3
|
33.3%
3/9 • Number of events 5
|
46.2%
6/13 • Number of events 8
|
75.0%
3/4 • Number of events 3
|
44.4%
4/9 • Number of events 7
|
53.8%
7/13 • Number of events 10
|
|
Nervous system disorders
Presyncope
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/13
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/13
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
7.7%
1/13 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/13
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Vascular disorders
Flushing
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/13
|
|
Congenital, familial and genetic disorders
Sickle cell anaemia with crisis
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/13
|
25.0%
1/4 • Number of events 2
|
22.2%
2/9 • Number of events 2
|
23.1%
3/13 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/13
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/13
|
25.0%
1/4 • Number of events 1
|
0.00%
0/9
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Chest pain
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/13
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Influenza like illness
|
0.00%
0/4
|
22.2%
2/9 • Number of events 2
|
15.4%
2/13 • Number of events 2
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Pain
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/13
|
0.00%
0/4
|
11.1%
1/9 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60