Trial Outcomes & Findings for A Study of Prasugrel in Healthy Participants (NCT NCT01648790)

Last Updated: 2013-11-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

20 participants

Primary outcome timeframe

Predose through 8 Hours Post Dose

Results posted on

2013-11-05

Participant Flow

Participants were to be given 5 single doses of prasugrel in 5 different sequences on each of 5 consecutive mornings of treatment.

Participant milestones

Participant milestones
Measure	Sequence 1 Day 1= 5 milligrams (mg) prasugrel without Magnasweet (reference) orally disintegrating tablet (ODT1), given on top of tongue in fasted state (T-Fast); Day 2= 5 mg prasugrel with Magnasweet (test) orally disintegrating tablet (ODT2),T-Fast; Day 3= 5 mg test ODT2, given dispersed in water in fasted state (W-Fast); Day 4= 5 mg test ODT2, given on top of tongue in fed state (T-Fed); Day 5= 2 mg test ODT2, T-Fast	Sequence 2 Day 1= 2 mg test ODT2, T-Fast; Day 2= 5 mg ODT1, T-Fast; Day 3= 5 mg test ODT2, T-Fast; Day 4= 5 mg test ODT2, W-Fast; Day 5= 5 mg test ODT2, T-Fed	Sequence 3 Day 1= 5 mg test ODT2, T-Fed; Day 2= 2 mg test ODT2, T-Fast; Day 3= 5 mg ODT1, T-Fast; Day 4= 5 mg test ODT2, T-Fast; Day 5= 5 mg test ODT2, W-Fast	Sequence 4 Day 1= 5 mg test ODT2, W-Fast; Day 2= 5 mg test ODT2, T-Fed; Day 3= 2 mg test ODT2, T-Fast; Day 4= 5 mg ODT1,T-Fast; Day 5= 5 mg test ODT2, T-Fast	Sequence 5 Day 1= 5 mg test ODT2, T-Fast; Day 2= 5 mg test ODT2, W-Fast; Day 3= 5 mg test ODT2, T-Fed; Day 4= 2 mg test ODT2, T-Fast; Day 5= 5 mg ODT1, T-Fast
Treatment 1 STARTED	4	4	4	4	4
Treatment 1 Received at Least 1 Dose of Study Drug	4	4	4	4	4
Treatment 1 COMPLETED	4	4	4	4	4
Treatment 1 NOT COMPLETED	0	0	0	0	0
Treatment 2 STARTED	4	4	4	4	4
Treatment 2 COMPLETED	4	4	4	4	4
Treatment 2 NOT COMPLETED	0	0	0	0	0
Treatment 3 STARTED	4	4	4	4	4
Treatment 3 COMPLETED	4	4	4	3	4
Treatment 3 NOT COMPLETED	0	0	0	1	0
Treatment 4 STARTED	4	4	4	3	4
Treatment 4 COMPLETED	4	4	4	3	4
Treatment 4 NOT COMPLETED	0	0	0	0	0
Treatment 5 STARTED	4	4	4	3	4
Treatment 5 COMPLETED	4	4	4	3	4
Treatment 5 NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Sequence 1 Day 1= 5 milligrams (mg) prasugrel without Magnasweet (reference) orally disintegrating tablet (ODT1), given on top of tongue in fasted state (T-Fast); Day 2= 5 mg prasugrel with Magnasweet (test) orally disintegrating tablet (ODT2),T-Fast; Day 3= 5 mg test ODT2, given dispersed in water in fasted state (W-Fast); Day 4= 5 mg test ODT2, given on top of tongue in fed state (T-Fed); Day 5= 2 mg test ODT2, T-Fast	Sequence 2 Day 1= 2 mg test ODT2, T-Fast; Day 2= 5 mg ODT1, T-Fast; Day 3= 5 mg test ODT2, T-Fast; Day 4= 5 mg test ODT2, W-Fast; Day 5= 5 mg test ODT2, T-Fed	Sequence 3 Day 1= 5 mg test ODT2, T-Fed; Day 2= 2 mg test ODT2, T-Fast; Day 3= 5 mg ODT1, T-Fast; Day 4= 5 mg test ODT2, T-Fast; Day 5= 5 mg test ODT2, W-Fast	Sequence 4 Day 1= 5 mg test ODT2, W-Fast; Day 2= 5 mg test ODT2, T-Fed; Day 3= 2 mg test ODT2, T-Fast; Day 4= 5 mg ODT1,T-Fast; Day 5= 5 mg test ODT2, T-Fast	Sequence 5 Day 1= 5 mg test ODT2, T-Fast; Day 2= 5 mg test ODT2, W-Fast; Day 3= 5 mg test ODT2, T-Fed; Day 4= 2 mg test ODT2, T-Fast; Day 5= 5 mg ODT1, T-Fast
Treatment 3 Withdrawal by Subject	0	0	0	1	0

Baseline Characteristics

A Study of Prasugrel in Healthy Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=20 Participants 5 mg Prasugrel as orally disintegrating tablet without Magnasweet® formulation (ODT1) or orally disintegrating tablet containing Magnasweet® formulation (ODT2) given either on top of tongue or dispersed in water administered in either the fasted or fed state. 2 mg prasugrel ODT2 given on top of tongue in the fasted state.
Age Continuous	39.3 years STANDARD_DEVIATION 10.5 • n=93 Participants
Sex: Female, Male Female	2 Participants n=93 Participants
Sex: Female, Male Male	18 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	11 Participants n=93 Participants
Race (NIH/OMB) White	8 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	20 participants n=93 Participants

PRIMARY outcome

Timeframe: Predose through 8 Hours Post Dose

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

Outcome measures

Outcome measures
Measure	5 mg Prasugrel (ODT1) n=19 Participants 5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered orally once in the fasted state.	5 mg Prasugrel (ODT2) n=19 Participants 5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered orally once in the fasted state.	5 mg Prasugrel (ODT2)-Suspension 5 mg Prasugrel as ODT2 formulation dispersed in water administered once, orally as suspension, in the fasted state.	5 mg Prasugrel (ODT2)-Fed 5 mg Prasugrel as ODT2 formulation administered orally once, following a standardized breakfast.	2 mg Prasugrel (ODT2) 2 mg Prasugrel as ODT2 formulation administered orally once in the fasted state.
Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test and Reference Formulation	28.6 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 41	28.1 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 51	—	—	—

PRIMARY outcome

Timeframe: Predose through 8 Hours Post Dose

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

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.

Outcome measures

Outcome measures
Measure	5 mg Prasugrel (ODT1) n=19 Participants 5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered orally once in the fasted state.	5 mg Prasugrel (ODT2) n=19 Participants 5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered orally once in the fasted state.	5 mg Prasugrel (ODT2)-Suspension 5 mg Prasugrel as ODT2 formulation dispersed in water administered once, orally as suspension, in the fasted state.	5 mg Prasugrel (ODT2)-Fed 5 mg Prasugrel as ODT2 formulation administered orally once, following a standardized breakfast.	2 mg Prasugrel (ODT2) 2 mg Prasugrel as ODT2 formulation administered orally once in the fasted state.
Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Reference and Test Formulation	27.1 nanogramshour per milliliter (ngh/mL) Geometric Coefficient of Variation 31	26.8 nanogramshour per milliliter (ngh/mL) Geometric Coefficient of Variation 38	—	—	—

SECONDARY outcome

Timeframe: Predose through 8 Hours Post Dose

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

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.

Outcome measures

Outcome measures
Measure	5 mg Prasugrel (ODT1) n=19 Participants 5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered orally once in the fasted state.	5 mg Prasugrel (ODT2) n=19 Participants 5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered orally once in the fasted state.	5 mg Prasugrel (ODT2)-Suspension n=20 Participants 5 mg Prasugrel as ODT2 formulation dispersed in water administered once, orally as suspension, in the fasted state.	5 mg Prasugrel (ODT2)-Fed n=20 Participants 5 mg Prasugrel as ODT2 formulation administered orally once, following a standardized breakfast.	2 mg Prasugrel (ODT2) n=19 Participants 2 mg Prasugrel as ODT2 formulation administered orally once in the fasted state.
Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test Formulation in Fasted and Fed State	28.6 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 41	28.1 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 51	31.5 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 45	7.79 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 60	8.81 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 47

SECONDARY outcome

Timeframe: Predose through 8 Hours Post Dose

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

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.