Trial Outcomes & Findings for Study of Prasugrel in Korean Healthy Male Volunteers (NCT NCT01591317)
NCT ID: NCT01591317
Last Updated: 2012-10-04
Results Overview
AUC from time zero to the last quantifiable plasma concentration (tlast)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
Day 1 predose up to 24 hours post dose
Results posted on
2012-10-04
Participant Flow
Participant milestones
| Measure |
Prasugrel - 60 mg/10 mg
Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days
|
Prasugrel - 30 mg/7.5 mg
Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days
|
Prasugrel - 30 mg/5 mg
Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Prasugrel in Korean Healthy Male Volunteers
Baseline characteristics by cohort
| Measure |
Prasugrel - 60 mg/10 mg
n=10 Participants
Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days
|
Prasugrel - 30 mg/7.5 mg
n=10 Participants
Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days
|
Prasugrel - 30 mg/5 mg
n=10 Participants
Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
28.2 years
STANDARD_DEVIATION 5.3 • n=93 Participants
|
25.9 years
STANDARD_DEVIATION 5.2 • n=4 Participants
|
26.0 years
STANDARD_DEVIATION 4.1 • n=27 Participants
|
26.7 years
STANDARD_DEVIATION 4.9 • n=483 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
30 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Asian
|
10 participants
n=93 Participants
|
10 participants
n=4 Participants
|
10 participants
n=27 Participants
|
30 participants
n=483 Participants
|
|
Region of Enrollment
Korea, Republic of
|
10 participants
n=93 Participants
|
10 participants
n=4 Participants
|
10 participants
n=27 Participants
|
30 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Day 1 predose up to 24 hours post dosePopulation: All randomized participants
AUC from time zero to the last quantifiable plasma concentration (tlast)
Outcome measures
| Measure |
Prasugrel 60 mg
n=10 Participants
Prasugrel 60 mg loading dose given once orally
|
Prasugrel 30 mg
n=20 Participants
Prasugrel 30 mg loading dose given once orally
|
Prasugrel - 30 mg/5 mg
Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
|
|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Prasugrel's Active Metabolite R-138727 During Loading Dose
|
600 nanogram times hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 16
|
283 nanogram times hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 17
|
—
|
PRIMARY outcome
Timeframe: Day 1 predose up to 24 hours post dosePopulation: All randomized participants
Outcome measures
| Measure |
Prasugrel 60 mg
n=10 Participants
Prasugrel 60 mg loading dose given once orally
|
Prasugrel 30 mg
n=20 Participants
Prasugrel 30 mg loading dose given once orally
|
Prasugrel - 30 mg/5 mg
Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
|
|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) for Prasugrel's Active Metabolite R-138727 During Loading Dose
|
498 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 41
|
271 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 39
|
—
|
PRIMARY outcome
Timeframe: Day 1 predose up to 24 hours post dosePopulation: All randomized participants
Outcome measures
| Measure |
Prasugrel 60 mg
n=10 Participants
Prasugrel 60 mg loading dose given once orally
|
Prasugrel 30 mg
n=20 Participants
Prasugrel 30 mg loading dose given once orally
|
Prasugrel - 30 mg/5 mg
Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
|
|---|---|---|---|
|
Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Prasugrel's Active Metabolite R-138727 During Loading Dose
|
0.50 hours
Interval 0.25 to 1.0
|
0.50 hours
Interval 0.25 to 1.0
|
—
|
PRIMARY outcome
Timeframe: Day 11 predose to 24 hours post dosePopulation: All randomized participants
AUC from time zero to the last quantifiable plasma concentration (tlast)
Outcome measures
| Measure |
Prasugrel 60 mg
n=10 Participants
Prasugrel 60 mg loading dose given once orally
|
Prasugrel 30 mg
n=10 Participants
Prasugrel 30 mg loading dose given once orally
|
Prasugrel - 30 mg/5 mg
n=10 Participants
Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
|
|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Prasugrel's Active Metabolite R-138727 During Maintenance Dose
|
78.1 ng*h/mL
Geometric Coefficient of Variation 24
|
58.4 ng*h/mL
Geometric Coefficient of Variation 21
|
38.3 ng*h/mL
Geometric Coefficient of Variation 24
|
PRIMARY outcome
Timeframe: Day 11 predose to 24 hours post dosePopulation: All randomized participants
Outcome measures
| Measure |
Prasugrel 60 mg
n=10 Participants
Prasugrel 60 mg loading dose given once orally
|
Prasugrel 30 mg
n=10 Participants
Prasugrel 30 mg loading dose given once orally
|
Prasugrel - 30 mg/5 mg
n=10 Participants
Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
|
|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) for Prasugrel's Active Metabolite R-138727 During Maintenance Dose
|
92.3 ng/mL
Geometric Coefficient of Variation 36
|
61.9 ng/mL
Geometric Coefficient of Variation 37
|
41.0 ng/mL
Geometric Coefficient of Variation 73
|
PRIMARY outcome
Timeframe: Day 11 predose to 24 hours post dosePopulation: All randomized participants
Outcome measures
| Measure |
Prasugrel 60 mg
n=10 Participants
Prasugrel 60 mg loading dose given once orally
|
Prasugrel 30 mg
n=10 Participants
Prasugrel 30 mg loading dose given once orally
|
Prasugrel - 30 mg/5 mg
n=10 Participants
Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
|
|---|---|---|---|
|
Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Prasugrel's Active Metabolite R-138727 During Maintenance Dose
|
0.50 hours
Interval 0.25 to 0.5
|
0.50 hours
Interval 0.25 to 0.52
|
0.38 hours
Interval 0.25 to 1.0
|
SECONDARY outcome
Timeframe: Predose up to 24 hours post dose on Day 12Population: All randomized participants
ADP-induced PRU represents the rate and extent of ADP-stimulated platelet aggregation and serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition
Outcome measures
| Measure |
Prasugrel 60 mg
n=10 Participants
Prasugrel 60 mg loading dose given once orally
|
Prasugrel 30 mg
n=10 Participants
Prasugrel 30 mg loading dose given once orally
|
Prasugrel - 30 mg/5 mg
n=10 Participants
Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
|
|---|---|---|---|
|
Pharmacodynamics: Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation
Day 1, predose
|
290 PRU
Standard Deviation 36.2
|
273 PRU
Standard Deviation 39.6
|
297 PRU
Standard Deviation 48.9
|
|
Pharmacodynamics: Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation
Day 1, 0.5 hours
|
118 PRU
Standard Deviation 120
|
107 PRU
Standard Deviation 95.5
|
172 PRU
Standard Deviation 102
|
|
Pharmacodynamics: Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation
Day 1, 1 hour
|
13.5 PRU
Standard Deviation 18.9
|
19.0 PRU
Standard Deviation 42.6
|
46.0 PRU
Standard Deviation 45.0
|
|
Pharmacodynamics: Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation
Day1, 2 hours
|
3.30 PRU
Standard Deviation 2.16
|
7.00 PRU
Standard Deviation 11.3
|
20.1 PRU
Standard Deviation 29.0
|
|
Pharmacodynamics: Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation
Day 1, 4 hours
|
2.70 PRU
Standard Deviation 1.89
|
3.10 PRU
Standard Deviation 1.73
|
12.1 PRU
Standard Deviation 24.0
|
|
Pharmacodynamics: Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation
Day 1, 24 hours
|
7.10 PRU
Standard Deviation 9.52
|
5.10 PRU
Standard Deviation 2.56
|
26.9 PRU
Standard Deviation 32.2
|
|
Pharmacodynamics: Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation
Day 10, predose
|
34.8 PRU
Standard Deviation 51.4
|
35.1 PRU
Standard Deviation 25.0
|
121 PRU
Standard Deviation 53.7
|
|
Pharmacodynamics: Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation
Day 11, predose
|
39.6 PRU
Standard Deviation 61.9
|
26.4 PRU
Standard Deviation 27.7
|
123 PRU
Standard Deviation 45.8
|
|
Pharmacodynamics: Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation
Day 11, 24 hours
|
24.4 PRU
Standard Deviation 26.7
|
27.2 PRU
Standard Deviation 31.8
|
107 PRU
Standard Deviation 53.7
|
SECONDARY outcome
Timeframe: Predose up to 24 hours post dose on Day 12Population: All randomized participants
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 60 mg
n=10 Participants
Prasugrel 60 mg loading dose given once orally
|
Prasugrel 30 mg
n=10 Participants
Prasugrel 30 mg loading dose given once orally
|
Prasugrel - 30 mg/5 mg
n=10 Participants
Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
|
|---|---|---|---|
|
Percent Inhibition of Verify Now (VN)-P2Y12 Reaction Units (PRU)
Day 1, predose
|
9.90 Percent inhibition of PRU
Standard Deviation 10.9
|
6.80 Percent inhibition of PRU
Standard Deviation 5.57
|
9.90 Percent inhibition of PRU
Standard Deviation 11.4
|
|
Percent Inhibition of Verify Now (VN)-P2Y12 Reaction Units (PRU)
Day 1, 0.5 hours
|
64.9 Percent inhibition of PRU
Standard Deviation 35.5
|
66.9 Percent inhibition of PRU
Standard Deviation 28.9
|
48.8 Percent inhibition of PRU
Standard Deviation 29.2
|
|
Percent Inhibition of Verify Now (VN)-P2Y12 Reaction Units (PRU)
Day 1, 1 hour
|
95.8 Percent inhibition of PRU
Standard Deviation 6.00
|
94.2 Percent inhibition of PRU
Standard Deviation 13.9
|
86.9 Percent inhibition of PRU
Standard Deviation 12.3
|
|
Percent Inhibition of Verify Now (VN)-P2Y12 Reaction Units (PRU)
Day1, 2 hours
|
98.9 Percent inhibition of PRU
Standard Deviation 0.568
|
97.7 Percent inhibition of PRU
Standard Deviation 3.47
|
94.0 Percent inhibition of PRU
Standard Deviation 8.26
|
|
Percent Inhibition of Verify Now (VN)-P2Y12 Reaction Units (PRU)
Day 1, 4 hours
|
99.2 Percent inhibition of PRU
Standard Deviation 0.632
|
99.1 Percent inhibition of PRU
Standard Deviation 0.738
|
96.8 Percent inhibition of PRU
Standard Deviation 6.00
|
|
Percent Inhibition of Verify Now (VN)-P2Y12 Reaction Units (PRU)
Day 1, 24 hours
|
97.8 Percent inhibition of PRU
Standard Deviation 2.94
|
98.3 Percent inhibition of PRU
Standard Deviation 0.675
|
92.0 Percent inhibition of PRU
Standard Deviation 9.51
|
|
Percent Inhibition of Verify Now (VN)-P2Y12 Reaction Units (PRU)
Day 10, predose
|
89.3 Percent inhibition of PRU
Standard Deviation 15.7
|
87.6 Percent inhibition of PRU
Standard Deviation 8.82
|
63.6 Percent inhibition of PRU
Standard Deviation 14.7
|
|
Percent Inhibition of Verify Now (VN)-P2Y12 Reaction Units (PRU)
Day 11, predose
|
88.5 Percent inhibition of PRU
Standard Deviation 18.4
|
91.2 Percent inhibition of PRU
Standard Deviation 9.07
|
64.8 Percent inhibition of PRU
Standard Deviation 12.9
|
|
Percent Inhibition of Verify Now (VN)-P2Y12 Reaction Units (PRU)
Day 11, 24 hours
|
92.5 Percent inhibition of PRU
Standard Deviation 7.43
|
91.0 Percent inhibition of PRU
Standard Deviation 10.0
|
67.0 Percent inhibition of PRU
Standard Deviation 17.2
|
Adverse Events
Prasugrel - 60 mg/10 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Prasugrel - 30 mg/7.5 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Prasugrel - 30 mg/5 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Prasugrel - 60 mg/10 mg
n=10 participants at risk
Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days
|
Prasugrel - 30 mg/7.5 mg
n=10 participants at risk
Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days
|
Prasugrel - 30 mg/5 mg
n=10 participants at risk
Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
|
|---|---|---|---|
|
General disorders
Chest discomfort
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
|
General disorders
Vessel puncture site paraesthesia
|
10.0%
1/10 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Contusion
|
10.0%
1/10 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
20.0%
2/10 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sputum retention
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Vascular disorders
Hot flush
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
10.0%
1/10 • 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