Food Interaction Study To Assess the Effect of Food on the Pharmacokinetics of Esomeprazole 20 mg/Acetylsalicylic Acid 81 mg

A Phase I, Open-label, Randomized, Single-center, 2-way Crossover Food Interaction Study To Assess the Effect of Food on the Pharmacokinetics of the Fixed Dose Combination Capsule of Esomeprazole 20 mg/Acetylsalicylic Acid 81 mg

The purpose of the study is to investigate the effects of food, in comparison to fasting conditions, on the extent and rate of absorption of acetylsalicylic acid (ASA) and esomeprazole.

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics; Effect of Food
• Intervention / Treatment: Drug: esomeprazole/ASA Fixed Dose Combination (FDC)

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Oveland Park, Kansas, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy adults who provide informed consent prior to any study-related procedures. Females must be of non-child bearing potential.
• Weight of 50-95kg, inclusive, and a BMI between 19-30 kg/m2, inclusive.
• No clinically significant abnormal findings as judged by the Investigator on enrollment physical exam.

Exclusion Criteria:

• Recent history of any clinically significant illness as judged by the Investigator within two weeks prior to enrolling in the study
• History of heart, kidney, liver. or gastrointestinal disease considered to be significant as judged by the Investigator
• Moderate to heavy smoking or other nicotine use (greater than 10 cigarettes per day or corresponding amount of nicotine)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; esomeprazole 20mg/ASA 81 mg FDC after a 10-hour fast	Drug: esomeprazole/ASA Fixed Dose Combination (FDC); esomeprazole 20 mg/ASA 81 mg oral capsule
Experimental: 2; esomeprazole 20mg/ASA 81 mg FDC 30 minutes after start of a high-fat, high-calorie breakfast	Drug: esomeprazole/ASA Fixed Dose Combination (FDC); esomeprazole 20 mg/ASA 81 mg oral capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To investigate the effects of food on the extent and rate of absorption of ASA and esomeprazole after a single dose administration of esomeprazole 20mg/ASA 81 mg FDC in healthy volunteers by assessment of AUC, AUC(0-t), and Cmax	Blood samples for ASA and SA analyses will be taken at predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 5, 6, 8, 10, 12, and 14 hours after dose administration
To investigate the effects of food on the extent and rate of absorption of ASA and esomeprazole after a single dose administration of esomeprazole 20mg/ASA 81 mg FDC in healthy volunteers by assessment of AUC, AUC(0-t), and Cmax	Blood samples for esomeprazole analysis will be taken at predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9, 10, 11, 12, 13, and 14 hours after dose adminstration

Secondary Outcome Measures

Outcome Measure	Time Frame
To investigate PK of ASA and esomeprazole by assessment of tmax and t1/2λz under fed and fasting conditions.	Blood samples for ASA and SA analyses will be taken at predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 5, 6, 8, 10, 12, and 14 hours after dose administration
To investigate the PK of ASA metabolite salicylic acid (SA) by assessment of AUC, AUC(0-t), Cmax, tmax and t1/2λz under fed and fasting conditions.	Blood samples for ASA and SA analyses will be taken at predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 5, 6, 8, 10, 12, and 14 hours after dose administration
To assess the safety and tolerability of esomeprazole 20mg/ASA 81 mg FDC.	AEs will be collected from the time of randomization up to and including the follow-up visit. SAEs will be recorded from the time of informed consent up to and including the follow up visit
To investigate the PK of ASA metabolite salicylic acid (SA) by assessment of AUC, AUC(0-t), Cmax, tmax and t1/2λz under fed and fasting conditions.	Blood samples for esomeprazole analysis will be taken at predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9, 10, 11, 12, 13, and 14 hours after dose adminstrationy.

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Kelli Craven, MD, Quintiles, Inc.; Study Director: Ken Price, AstraZeneca; Study Director: Mirjana Kujacic, AstraZeneca

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: July 14, 2010
• First Submitted That Met QC Criteria: July 15, 2010
• First Posted (Estimate): July 16, 2010

Study Record Updates

• Last Update Posted (Estimate): December 7, 2010
• Last Update Submitted That Met QC Criteria: December 6, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: open label, randomized; single-center; 2-way crossover; food interaction study
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: D961FC00009