Healthy VolunteersPhase 1NCT01591317

Study of Prasugrel in Korean Healthy Male Volunteers

A Phase 1 study testing Prasugrel in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to investigate how the body processes prasugrel and how prasugrel affects blood clotting in healthy Korean men. Three different dosing regimens of prasugrel will be given. Information on side effects will also be collected. Read more about this study

Who is it for?: Ages 20 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Prasugrel
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteSouth Korea
Study dates: Mar 2009to May 2009
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Are overtly healthy males, as determined by medical history and physical examination.
Are between the ages of 20 and 45 years, inclusive.
Have a body mass index (BMI) of 19 kg/m^2 to 27 kg/m^2, inclusive, at screening.

Who cannot join

Are currently enrolled in, or discontinued within the last 60 days from a clinical trial involving an investigational drug or device, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Have known allergies to prasugrel or related compounds.
Are persons who have previously completed or withdrawn from this study or any other study investigating prasugrel.
Self-reported history of significant bleeding from trauma (for example, prolonged bleeding after tooth extraction).
History of major surgery within 3 months of screening or planned surgery within 14 days after the last day of dosing.
Have a platelet count of <100,000/(cubic millimeters) mm^3 at the time of screening.

Show all 12Show fewer

Have tested positive for fecal occult blood at screening.
Have significant prolongation of prothrombin time (PT) or activated partial thromboplastin time (APTT) at screening.
Have a clinically significant abnormality following the investigator's review of the physical examination, electrocardiogram (ECG)and clinical (safety) laboratory tests at screening.
Personal or first-degree family history of coagulation or bleeding disorders (that is, hematemesis, melena, severe or recurrent epistaxis, hemoptysis, gastrointestinal ulcers, hemorrhage, clinically overt hematuria or intracranial hemorrhage) or reasonable suspicion of vascular malformations, for example, cerebral hemorrhage, aneurysm or premature stroke (cerebrovascular accident [CVA] <65 years of age).
Have significant active hematological disease and/or whole blood donation of more than 400 mL within the last 2 months and component blood donation within the last month.
Volunteers who have an average weekly alcohol intake that exceeds 21 units per week or volunteers unwilling to adhere to study alcohol restrictions during the study (1 unit = 360 mL of beer; 150 mL of wine; 45 mL of distilled spirits).

Trial locations and contacts

1 site in 1 country.

South Korea1 site

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.
Seoul

Other trials in South Korea

About this study

Official title: Single and Multiple Dose Pharmacokinetics and Pharmacodynamics of Prasugrel (LY640315) in Korean Healthy Male Subjects

Conditions: Healthy Volunteers
Being tested: Prasugrel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PrasugrelDrug
Also called LY640315, Effient, Efient, Prasita
Tablets orally

Study groups in NCT01591317
Study group	Role	What they receive
Prasugrel - 60 mg/10 mg	Experimental	Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days Receives: Drug: Prasugrel
Prasugrel - 30 mg/7.5 mg	Experimental	Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days Receives: Drug: Prasugrel
Prasugrel - 30 mg/5 mg	Experimental	Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days Receives: Drug: Prasugrel

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Prasugrel's Active Metabolite R-138727 During Loading Dose
AUC from time zero to the last quantifiable plasma concentration (tlast)
Measured: Day 1 predose up to 24 hours post dose
Pharmacokinetics (PK): Maximum Concentration (Cmax) for Prasugrel's Active Metabolite R-138727 During Loading Dose
Measured: Day 1 predose up to 24 hours post dose
Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Prasugrel's Active Metabolite R-138727 During Loading Dose
Measured: Day 1 predose up to 24 hours post dose
Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Prasugrel's Active Metabolite R-138727 During Maintenance Dose
AUC from time zero to the last quantifiable plasma concentration (tlast)
Measured: Day 11 predose to 24 hours post dose
Pharmacokinetics (PK): Maximum Concentration (Cmax) for Prasugrel's Active Metabolite R-138727 During Maintenance Dose
Measured: Day 11 predose to 24 hours post dose
Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Prasugrel's Active Metabolite R-138727 During Maintenance Dose
Measured: Day 11 predose to 24 hours post dose

Secondary outcomes (2)

Pharmacodynamics: Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation
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
Measured: Predose up to 24 hours post dose on Day 12
Percent Inhibition of Verify Now (VN)-P2Y12 Reaction Units (PRU)
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
Measured: Predose up to 24 hours post dose on Day 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009May 2009

First posted4 May 2012 (estimated)
Study startMar 2009
Primary completionMay 2009
Study completionMay 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01591317
Sponsor's protocol ID: 11990
Other IDs: H7T-FW-TACQ
Status last verified: Sep 2012
First submitted: 2 May 2012
Last updated: 4 Oct 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Yu KS, Park KW, Kelly RP, Gu N, Payne C, Small DS, Choi HC, Kawakatsu E, Pinton P. Pharmacokinetic and pharmacodynamic effects of prasugrel in healthy Korean males. J Cardiovasc Pharmacol. 2013 Jul;62(1):72-7. doi: 10.1097/FJC.0b013e318290d9e1.
PubMed 23594968

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain

All Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single and Multiple Dose Pharmacokinetics and Pharmacodynamics of Prasugrel (LY640315) in Korean Healthy Male Subjects
ClinicalTrials.gov ID: NCT01591317
Acronym / sponsor ID: 11990
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: May 2009 (actual)
Study completion: May 2009 (actual)
First posted: 4 May 2012 (estimated)
Results: Posted 4 Oct 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Prasugrel - 60 mg/10 mg	Experimental	Drug: PrasugrelPrasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days
Prasugrel - 30 mg/7.5 mg	Experimental	Drug: PrasugrelPrasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days
Prasugrel - 30 mg/5 mg	Experimental	Drug: PrasugrelPrasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days

Who may qualify

Ages: 20 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Are overtly healthy males, as determined by medical history and physical examination.
Are between the ages of 20 and 45 years, inclusive.
Have a body mass index (BMI) of 19 kg/m^2 to 27 kg/m^2, inclusive, at screening.

Key exclusion criteria (12 listed)

Are currently enrolled in, or discontinued within the last 60 days from a clinical trial involving an investigational drug or device, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Have known allergies to prasugrel or related compounds.
Are persons who have previously completed or withdrawn from this study or any other study investigating prasugrel.
Self-reported history of significant bleeding from trauma (for example, prolonged bleeding after tooth extraction).
History of major surgery within 3 months of screening or planned surgery within 14 days after the last day of dosing.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PrasugrelAlso: LY640315, Effient, Efient, PrasitaTablets orally	Drug	Prasugrel - 30 mg/5 mg, Prasugrel - 30 mg/7.5 mg, Prasugrel - 60 mg/10 mg

Primary outcome

Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Prasugrel's Active Metabolite R-138727 During Loading Dose
Time frame: Day 1 predose up to 24 hours post dose
AUC from time zero to the last quantifiable plasma concentration (tlast)
Pharmacokinetics (PK): Maximum Concentration (Cmax) for Prasugrel's Active Metabolite R-138727 During Loading Dose
Time frame: Day 1 predose up to 24 hours post dose
Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Prasugrel's Active Metabolite R-138727 During Loading Dose
Time frame: Day 1 predose up to 24 hours post dose
Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Prasugrel's Active Metabolite R-138727 During Maintenance Dose
Time frame: Day 11 predose to 24 hours post dose
AUC from time zero to the last quantifiable plasma concentration (tlast)
Pharmacokinetics (PK): Maximum Concentration (Cmax) for Prasugrel's Active Metabolite R-138727 During Maintenance Dose
Time frame: Day 11 predose to 24 hours post dose
Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Prasugrel's Active Metabolite R-138727 During Maintenance Dose
Time frame: Day 11 predose to 24 hours post dose

2 secondary outcomes

Pharmacodynamics: Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation
Time frame: Predose up to 24 hours post dose on Day 12
Percent Inhibition of Verify Now (VN)-P2Y12 Reaction Units (PRU)
Time frame: Predose up to 24 hours post dose on Day 12

Results and safety

Results posted to the registry on 4 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Prasugrel - 60 mg/10 mg	10	10
Prasugrel - 30 mg/7.5 mg	10	10
Prasugrel - 30 mg/5 mg	10	10

Primary outcome: Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Prasugrel's Active Metabolite R-138727 During Loading Dose

Time frame: Day 1 predose up to 24 hours post dose. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram times hour/milliliter (ng*h/mL)

Measure	Prasugrel 60 mg n = 10	Prasugrel 30 mg n = 20
Value	600 (16)	283 (17)

Population analysed: All randomized participants

Primary outcome: Pharmacokinetics (PK): Maximum Concentration (Cmax) for Prasugrel's Active Metabolite R-138727 During Loading Dose

Time frame: Day 1 predose up to 24 hours post dose. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram/milliliter (ng/mL)

Measure	Prasugrel 60 mg n = 10	Prasugrel 30 mg n = 20
Value	498 (41)	271 (39)

Population analysed: All randomized participants

Primary outcome: Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Prasugrel's Active Metabolite R-138727 During Loading Dose

Time frame: Day 1 predose up to 24 hours post dose. Median (Full Range). Unit: hours

Measure	Prasugrel 60 mg n = 10	Prasugrel 30 mg n = 20
Value	0.50 (0.25 to 1.00)	0.50 (0.25 to 1.00)

Population analysed: All randomized participants

Primary outcome: Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Prasugrel's Active Metabolite R-138727 During Maintenance Dose

Time frame: Day 11 predose to 24 hours post dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Prasugrel 10 mg n = 10	Prasugrel 7.5 mg n = 10	Prasugrel 5 mg n = 10
Value	78.1 (24)	58.4 (21)	38.3 (24)

Population analysed: All randomized participants

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Prasugrel - 60 mg/10 mg	0 of 10 (0%)	3 of 10 (30%)	Not reported
Prasugrel - 30 mg/7.5 mg	0 of 10 (0%)	4 of 10 (40%)	Not reported
Prasugrel - 30 mg/5 mg	0 of 10 (0%)	3 of 10 (30%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23594968Yu KS, Park KW, Kelly RP, Gu N, Payne C, Small DS, Choi HC, Kawakatsu E, Pinton P. Pharmacokinetic and pharmacodynamic effects of prasugrel in healthy Korean males. J Cardiovasc Pharmacol. 2013 Jul;62(1):72-7. doi: 10.1097/FJC.0b013e318290d9e1.

Related trials for Healthy Volunteers

Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Prasugrel in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Prasugrel's Active Metabolite R-138727 During Loading Dose (time frame: Day 1 predose up to 24 hours post dose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01591317, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2012.