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CompletedNCT01648790Updated Nov 5, 2013Results posted

A Study of Prasugrel in Healthy Participants

A Phase 1 interventional study of Prasugrel ODT1 - Tablet and Prasugrel ODT2 - Tablet in Healthy Volunteers, sponsored by Eli Lilly and Company. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-11-05.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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).

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    5 mg Prasugrel (ODT1)

    5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered once in the fasted state.

    Drug: Prasugrel ODT1 - Tablet

  • Experimental
    5 mg Prasugrel (ODT2)

    5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered once in the fasted state.

    Drug: Prasugrel ODT2 - Tablet

  • Experimental
    5 mg Prasugrel (ODT2)-Suspension

    5 mg Prasugrel as ODT2 formulation dispersed in water administered once, in the fasted state.

    Drug: Prasugrel ODT2 - Suspension

  • Experimental
    5 mg Prasugrel (ODT2)-Fed

    5 mg Prasugrel as ODT2 formulation administered once, following a standardized breakfast.

    Drug: Prasugrel ODT2 - Tablet

  • Experimental
    2 mg Prasugrel (ODT2)

    2 mg Prasugrel as ODT2 formulation administered once in the fasted state.

    Drug: Prasugrel ODT2 - Tablet

Interventions

  • DrugPrasugrel ODT1 - Tablet

    Administered orally as tablet.

    Also known as: LY640315, Effient, Efient

  • DrugPrasugrel ODT2 - Tablet

    Administered orally as tablet.

    Also known as: LY640315, Effient, Efient

  • DrugPrasugrel ODT2 - Suspension

    Administered orally as suspension.

    Also known as: LY640315, Effient, Efient

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Predose through 8 Hours Post Dose

  2. 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.

    Time frame: Predose through 8 Hours Post Dose

Secondary outcomes

  1. 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.

    Time frame: Predose through 8 Hours Post Dose

  2. 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.

    Time frame: Predose through 8 Hours Post Dose

07

Results

Posted Nov 5, 2013

Participant flow

Treatment 1
Participant flow — Treatment 1
MilestoneSequence 1Sequence 2Sequence 3Sequence 4Sequence 5
Started44444
Received at least 1 dose of study drug44444
Completed44444
Not completed00000
Treatment 2
Participant flow — Treatment 2
MilestoneSequence 1Sequence 2Sequence 3Sequence 4Sequence 5
Started44444
Completed44444
Not completed00000
Treatment 3
Participant flow — Treatment 3
MilestoneSequence 1Sequence 2Sequence 3Sequence 4Sequence 5
Started44444
Completed44434
Not completed00010
Withdrew: Withdrawal by subject00010
Treatment 4
Participant flow — Treatment 4
MilestoneSequence 1Sequence 2Sequence 3Sequence 4Sequence 5
Started44434
Completed44434
Not completed00000
Treatment 5
Participant flow — Treatment 5
MilestoneSequence 1Sequence 2Sequence 3Sequence 4Sequence 5
Started44434
Completed44434
Not completed00000

Outcome measures

PrimaryPharmacokinetics: 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.

Time frame:
Predose through 8 Hours Post Dose
Reported as:
Geometric mean · nanograms per milliliter (ng/mL)
Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test and Reference Formulation
nanograms per milliliter (ng/mL)5 mg Prasugrel (ODT1)5 mg Prasugrel (ODT2)
Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test and Reference Formulation28.6 ± 4128.1 ± 51
Statistical analysis
  • 5 mg Prasugrel (ODT1) vs 5 mg Prasugrel (ODT2) · Ratio of geometric least squares means: 0.983 · 90% CI 0.819 to 1.18Least Squares (LS) means were determined by mixed-effect linear models with treatment, period, sequence as fixed effects, and participants nested within sequence as random effect.
PrimaryPharmacokinetics: 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.

Time frame:
Predose through 8 Hours Post Dose
Reported as:
Geometric mean · nanograms*hour per milliliter (ng*h/mL)
Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Reference and Test Formulation
nanograms*hour per milliliter (ng*h/mL)5 mg Prasugrel (ODT1)5 mg Prasugrel (ODT2)
Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Reference and Test Formulation27.1 ± 3126.8 ± 38
Statistical analysis
  • 5 mg Prasugrel (ODT1) vs 5 mg Prasugrel (ODT2) · Ratio of geometric least squares means: 0.987 · 90% CI 0.918 to 1.06LS means were determined by mixed-effect linear models with treatment, period, sequence as fixed effects, and participants nested within sequence as random effect.
SecondaryPharmacokinetics: 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.

Time frame:
Predose through 8 Hours Post Dose
Reported as:
Geometric mean · nanograms per milliliter (ng/mL)
Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test Formulation in Fasted and Fed State
nanograms per milliliter (ng/mL)5 mg Prasugrel (ODT1)5 mg Prasugrel (ODT2)5 mg Prasugrel (ODT2)-Suspension5 mg Prasugrel (ODT2)-Fed2 mg Prasugrel (ODT2)
Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test Formulation in Fasted and Fed State28.6 ± 4128.1 ± 5131.5 ± 457.79 ± 608.81 ± 47
Statistical analysis
  • 5 mg Prasugrel (ODT2) vs 5 mg Prasugrel (ODT2)-Fed · Ratio of geometric least squares means: 0.280 · 90% CI 0.233 to 0.335LS means were determined by mixed-effect linear models with treatment, period, sequence as fixed effects, and participants nested within sequence as random effect.
SecondaryPharmacokinetics: 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.

Time frame:
Predose through 8 Hours Post Dose
Reported as:
Geometric mean · nanograms*hour per milliliter (ng*h/mL)
Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Test Formulation in Fasted and Fed State
nanograms*hour per milliliter (ng*h/mL)5 mg Prasugrel (ODT1)5 mg Prasugrel (ODT2)5 mg Prasugrel (ODT2)-Suspension5 mg Prasugrel (ODT2)-Fed2 mg Prasugrel (ODT2)
Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Test Formulation in Fasted and Fed State27.1 ± 3126.8 ± 3827 ± 3220.8 ± 398.97 ± 31
Statistical analysis
  • 5 mg Prasugrel (ODT2) vs 5 mg Prasugrel (ODT2)-Fed · Ratio of geometric least squares means: 0.779 · 90% CI 0.724 to 0.837LS means were determined by mixed-effect linear models with treatment, period, sequence as fixed effects, and participants nested within sequence as random effect.

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
5 mg Prasugrel (ODT1)—0/19 (0%)1/19 (5.3%)
5 mg Prasugrel (ODT2)—0/19 (0%)0/19 (0%)
5 mg Prasugrel (ODT2)-Suspension—0/20 (0%)0/20 (0%)
5 mg Prasugrel (ODT2)-Fed—0/20 (0%)2/20 (10%)
2 mg Prasugrel (ODT2)—0/19 (0%)1/19 (5.3%)
Most frequent other events
Most frequent other events
Event5 mg Prasugrel (ODT1)5 mg Prasugrel (ODT2)5 mg Prasugrel (ODT2)-Suspension5 mg Prasugrel (ODT2)-Fed2 mg Prasugrel (ODT2)
Procedural dizzinessInjury, poisoning and procedural complications0/190/190/200/201/19
SyncopeNervous system disorders1/190/190/200/200/19
Gingival bleedingGastrointestinal disorders0/190/190/201/200/19
MyalgiaMusculoskeletal and connective tissue disorders0/190/190/201/200/19

Baseline characteristics

Age Continuous
Age Continuous(years)All Participants
Mean39.3 ± 10.5
Sex: Female, Male
Sex: Female, Male(Participants)All Participants
Female2
Male18
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)All Participants
Hispanic or Latino5
Not Hispanic or Latino15
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)All Participants
American Indian or Alaska Native1
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American11
White8
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)All Participants
United States20
08

Study locations

1 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, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 5, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01648790
Lead sponsor
Eli Lilly and Company
Collaborators
Daiichi Sankyo
Responsible party
Sponsor
First posted
Jul 24, 2012
Start date
Jul 2012
Primary completion
Aug 2012
Completion
Aug 2012
Results posted
Nov 5, 2013
Last update
Nov 5, 2013

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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