Healthy VolunteersPhase 1NCT01648790

A Study of Prasugrel in Healthy Participants

A Phase 1 study testing Prasugrel ODT1 - Tablet, Prasugrel ODT2 - Tablet and Prasugrel ODT2 - Suspension in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in United States.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Prasugrel ODT1 - Tablet, Prasugrel ODT2 - Tablet and Prasugrel ODT2 - Suspension
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Jul 2012to Aug 2012
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Body mass index (BMI) of 18.5 to 32.0 kilograms per square meter (kg/m^2)

Who cannot join

No known allergies to Prasugrel or related compound
No regular alcohol intake greater than 21 units per week for males or 14 units per week for females

Trial locations and contacts

1 site in 1 country.

United States1 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.
Dallas, Texas

Other trials in United States

About this study

Official title: Relative Bioavailability of Prasugrel Orally Disintegrating Tablet Formulations and the Effect of Food on the Bioavailability of the Orally Disintegrating Tablet in Healthy Subjects

The purpose of this study is to evaluate the amount of drug available in the body when given to healthy participants as two different formulations with or without a meal. In addition, this study will evaluate how much of the drug gets into the blood stream and how long the body takes to get rid of it. Information about any side effects that may occur will also be collected. Each participant will receive a total of five different treatments. Each treatment is given by mouth, once a day. The treatment period lasts for five consecutive days.

Read the detailed description

The reference formulation is an orally disintegrating tablet without Magnasweet® (ODT1) and the test formulation is an orally disintegrating tablet containing Magnasweet® (ODT2).

Conditions: Healthy Volunteers
Being tested: Prasugrel ODT1 - Tablet, Prasugrel ODT2 - Tablet, Prasugrel ODT2 - Suspension

What participants receive

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

Prasugrel ODT1 - TabletDrug
Also called LY640315, Effient, Efient
Administered orally as tablet.
Prasugrel ODT2 - TabletDrug
Also called LY640315, Effient, Efient
Administered orally as tablet.
Prasugrel ODT2 - SuspensionDrug
Also called LY640315, Effient, Efient
Administered orally as suspension.

Study groups in NCT01648790
Study group	Role	What they receive
5 mg Prasugrel (ODT1)	Experimental	5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered once in the fasted state. Receives: Drug: Prasugrel ODT1 - Tablet
5 mg Prasugrel (ODT2)	Experimental	5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered once in the fasted state. Receives: Drug: Prasugrel ODT2 - Tablet
5 mg Prasugrel (ODT2)-Suspension	Experimental	5 mg Prasugrel as ODT2 formulation dispersed in water administered once, in the fasted state. Receives: Drug: Prasugrel ODT2 - Suspension
5 mg Prasugrel (ODT2)-Fed	Experimental	5 mg Prasugrel as ODT2 formulation administered once, following a standardized breakfast. Receives: Drug: Prasugrel ODT2 - Tablet
2 mg Prasugrel (ODT2)	Experimental	2 mg Prasugrel as ODT2 formulation administered once in the fasted state. Receives: Drug: Prasugrel ODT2 - Tablet

What is being measured

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

Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test and Reference Formulation
Cmax= maximum concentration measured from predose through 8 hours postdose. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) and the reference formulation is defined as the orally disintegrating tablet without Magnasweet® (ODT1) specific to the 5 milligrams (mg) prasugrel dosing. Pharmacokinetics will measure prasugrel's (LY640315) active metabolite.
Measured: Predose through 8 Hours Post Dose
Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Reference and Test Formulation
AUC(0-tlast) = area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) and the reference formulation is defined as the orally disintegrating tablet without Magnasweet® (ODT1) specific to the 5 mg prasugrel dosing. Pharmacokinetics will measure prasugrel's active metabolite.
Measured: Predose through 8 Hours Post Dose

Secondary outcomes (2)

Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test Formulation in Fasted and Fed State
Cmax= maximum concentration measured from predose through 8 hours postdose. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) specific to the 5 mg prasugrel dosing in the fasted and fed state. Pharmacokinetics will measure prasugrel's active metabolite.
Measured: Predose through 8 Hours Post Dose
Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Test Formulation in Fasted and Fed State
AUC(0-tlast) = area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) specific to the 5 mg prasugrel dosing in the fasted and fed state. Pharmacokinetics will measure prasugrel's active metabolite.
Measured: Predose through 8 Hours Post Dose

Timeline

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

Jul 2012Aug 2012

First posted24 Jul 2012 (estimated)
Study startJul 2012
Primary completionAug 2012
Study completionAug 2012

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.
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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01648790
Sponsor's protocol ID: 14686
Other IDs: H7T-EW-TAEQ
Status last verified: Aug 2013
First submitted: 20 Jul 2012
Last updated: 5 Nov 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

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Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relative Bioavailability of Prasugrel Orally Disintegrating Tablet Formulations and the Effect of Food on the Bioavailability of the Orally Disintegrating Tablet in Healthy Subjects
ClinicalTrials.gov ID: NCT01648790
Acronym / sponsor ID: 14686
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: Daiichi Sankyo
Study start: Jul 2012
Primary completion: Aug 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 24 Jul 2012 (estimated)
Results: Posted 5 Nov 2013

Clinical summary

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

Detailed description

The reference formulation is an orally disintegrating tablet without Magnasweet® (ODT1) and the test formulation is an orally disintegrating tablet containing Magnasweet® (ODT2).

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
5 mg Prasugrel (ODT1)	Experimental	Drug: Prasugrel ODT1 - Tablet5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered once in the fasted state.
5 mg Prasugrel (ODT2)	Experimental	Drug: Prasugrel ODT2 - Tablet5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered once in the fasted state.
5 mg Prasugrel (ODT2)-Suspension	Experimental	Drug: Prasugrel ODT2 - Suspension5 mg Prasugrel as ODT2 formulation dispersed in water administered once, in the fasted state.
5 mg Prasugrel (ODT2)-Fed	Experimental	Drug: Prasugrel ODT2 - Tablet5 mg Prasugrel as ODT2 formulation administered once, following a standardized breakfast.
2 mg Prasugrel (ODT2)	Experimental	Drug: Prasugrel ODT2 - Tablet2 mg Prasugrel as ODT2 formulation administered once in the fasted state.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Body mass index (BMI) of 18.5 to 32.0 kilograms per square meter (kg/m^2)

Key exclusion criteria (2 listed)

No known allergies to Prasugrel or related compound
No regular alcohol intake greater than 21 units per week for males or 14 units per week for females

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
Prasugrel ODT1 - TabletAlso: LY640315, Effient, EfientAdministered orally as tablet.	Drug	5 mg Prasugrel (ODT1)
Prasugrel ODT2 - TabletAlso: LY640315, Effient, EfientAdministered orally as tablet.	Drug	2 mg Prasugrel (ODT2), 5 mg Prasugrel (ODT2), 5 mg Prasugrel (ODT2)-Fed
Prasugrel ODT2 - SuspensionAlso: LY640315, Effient, EfientAdministered orally as suspension.	Drug	5 mg Prasugrel (ODT2)-Suspension

Primary outcome

Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test and Reference Formulation
Time frame: Predose through 8 Hours Post Dose
Cmax= maximum concentration measured from predose through 8 hours postdose. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) and the reference formulation is defined as the orally disintegrating tablet without Magnasweet® (ODT1) specific to the 5 milligrams (mg) prasugrel dosing. Pharmacokinetics will measure prasugrel's (LY640315) active metabolite.
Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Reference and Test Formulation
Time frame: Predose through 8 Hours Post Dose
AUC(0-tlast) = area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) and the reference formulation is defined as the orally disintegrating tablet without Magnasweet® (ODT1) specific to the 5 mg prasugrel dosing. Pharmacokinetics will measure prasugrel's active metabolite.

2 secondary outcomes

Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test Formulation in Fasted and Fed State
Time frame: Predose through 8 Hours Post Dose
Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Test Formulation in Fasted and Fed State
Time frame: Predose through 8 Hours Post Dose

Results and safety

Results posted to the registry on 5 Nov 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1	4	4
Sequence 2	4	4
Sequence 3	4	4
Sequence 4	4	4
Sequence 5	4	4

Primary outcome: Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test and Reference Formulation

Time frame: Predose through 8 Hours Post Dose. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms per milliliter (ng/mL)

Measure	5 mg Prasugrel (ODT1) n = 19	5 mg Prasugrel (ODT2) n = 19
Value	28.6 (41)	28.1 (51)

5 mg Prasugrel (ODT1) vs 5 mg Prasugrel (ODT2): Ratio of Geometric Least Squares Means: 0.983 (90% CI 0.819 to 1.18)

Population analysed: Pharmacokinetic population consists of all participants who received at least one dose of study drug and have evaluable pharmacokinetic data.

Primary outcome: Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Reference and Test Formulation

Time frame: Predose through 8 Hours Post Dose. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms*hour per milliliter (ng*h/mL)

Measure	5 mg Prasugrel (ODT1) n = 19	5 mg Prasugrel (ODT2) n = 19
Value	27.1 (31)	26.8 (38)

5 mg Prasugrel (ODT1) vs 5 mg Prasugrel (ODT2): Ratio of Geometric Least Squares Means: 0.987 (90% CI 0.918 to 1.06)

Population analysed: Pharmacokinetic population consists of all participants who received at least one dose of study drug and have evaluable pharmacokinetic data.

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
5 mg Prasugrel (ODT1)	0 of 19 (0%)	1 of 19 (5.3%)	Not reported
5 mg Prasugrel (ODT2)	0 of 19 (0%)	0 of 19 (0%)	Not reported
5 mg Prasugrel (ODT2)-Suspension	0 of 20 (0%)	0 of 20 (0%)	Not reported
5 mg Prasugrel (ODT2)-Fed	0 of 20 (0%)	2 of 20 (10%)	Not reported
2 mg Prasugrel (ODT2)	0 of 19 (0%)	1 of 19 (5.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 ODT1 - Tablet, Prasugrel ODT2 - Tablet and Prasugrel ODT2 - Suspension in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in United States.

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 1 inclusion and 2 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 5 Nov 2013. 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 United States. 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 5 Nov 2013). 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: Maximum Concentration (Cmax) of Prasugrel Test and Reference Formulation (time frame: Predose through 8 Hours Post Dose). The study lists 2 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 NCT01648790.

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 5 Nov 2013.