A Study of Prasugrel in Healthy Participants

NCT01648790 | Completed Phase 1 Results

• 2 other identifiers: 14686H7T-EW-TAEQ
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Predose through 8 Hours Post Dose

Secondary Outcomes (2)

• Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test Formulation in Fasted and Fed State

  Predose through 8 Hours Post Dose

• Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Test Formulation in Fasted and Fed State

  Predose through 8 Hours Post Dose

Study Arms (5)

5 mg Prasugrel (ODT1)

EXPERIMENTAL

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

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.

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.

Drug: Prasugrel ODT2 - Suspension

5 mg Prasugrel (ODT2)-Fed

EXPERIMENTAL

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

Drug: Prasugrel ODT2 - Tablet

2 mg Prasugrel (ODT2)

EXPERIMENTAL

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

Drug: Prasugrel ODT2 - Tablet

Interventions

Prasugrel ODT1 - Tablet DRUG

Administered orally as tablet.

Also known as: LY640315, Effient, Efient

5 mg Prasugrel (ODT1)

Prasugrel ODT2 - Tablet DRUG

Administered orally as tablet.

Also known as: LY640315, Effient, Efient

2 mg Prasugrel (ODT2); 5 mg Prasugrel (ODT2); 5 mg Prasugrel (ODT2)-Fed

Prasugrel ODT2 - Suspension DRUG

Administered orally as suspension.

Also known as: LY640315, Effient, Efient

5 mg Prasugrel (ODT2)-Suspension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Daiichi Sankyo: collaborator

Study Sites (1)

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

Location

MeSH Terms

Interventions

Prasugrel Hydrochloride

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2012
• First Posted: July 24, 2012
• Study Start: July 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: November 5, 2013
• Results First Posted: November 5, 2013

Record last verified: 2013-08

Locations

US (1)