A Bioequivalence Study of SCH 530348 2.5 mg Tablets (P06558)

A Study to Determine the Bioequivalence of SCH 530348 2.5 mg Tablets Containing a High and Low Percentage of Drug as the Free Base Within the Range Used in the Pivotal Phase 3 Efficacy and Safety Trials. (Protocol No. P06558)

The purpose of this study is determine if SCH 530348 2.5 mg tablets containing a high percentage of drug as the free base are equivalent to tablets with the standard percentage when given to participants.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Drug: Pantoprazole; Drug: SCH 530348 (standard percentage); Drug: SCH 530348 (high percentage)

• Study Type: Interventional
• Enrollment (Actual): 173
• Phase: Phase 1

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:

• Body Mass Index (BMI) between 18 and 32, inclusive
• Clinical laboratory tests within normal limits
• Free of any clinically significant disease that would interfere with the study evaluations
• Screening 12-lead electrocardiogram (ECG) conduction intervals within gender-specific normal range
• Vital sign measurements within the following ranges: oral body temperature, 35.0°C to 37.5°C; systolic blood pressure, 90 to 140 mmHg; diastolic blood pressure, 45 to 90 mmHg; pulse rate, 40 to 100 beats per minute
• Female participants must be postmenopausal, surgically sterile, abstinent, or using medically accepted method of contraception for 3 months prior to the screening period, during the trial, and for 2 months after stopping the trial. Non-vasectomized men must agree to use acceptable contraception or to abstain from sexual intercourse during the trial and for 3 months after stopping the medication

Exclusion Criteria:

• Female participants who are pregnant, intend to become pregnant (within 3 months of ending the study), or are breastfeeding
• History of coagulation disorder(s), thrombocytopenia, bleeding tendency, ulcers, or gastrointestinal bleeding
• History of cardiac abnormalities including clinically relevant ECGs, frequent palpitations or syncopal episodes
• Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism or excretion of any drug
• History of any infectious disease within 4 weeks prior to drug administration
• Positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV)
• Positive screen for drugs with a high potential for abuse
• History of alcohol or drug abuse in the past 2 years
• Blood donation in the past 60 days
• Previous treatment with SCH 530348
• Currently participating in another clinical study or has participated in a clinical study within 30 days
• Demonstrated allergic reactions
• Smokes more than 10 cigarettes or equivalent tobacco use per day
• History of malignancy
• Has received any protocol-defined treatment which could interfere with ability to participate in the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Standard Percentage	Drug: Pantoprazole; 40 mg delayed-release tablet administered orally in the morning of Days 1-7; Drug: SCH 530348 (standard percentage); 2.5 mg tablet containing ~23% API as free base (STANDARD) administered orally on the morning of Day 5
EXPERIMENTAL: High Percentage	Drug: Pantoprazole; 40 mg delayed-release tablet administered orally in the morning of Days 1-7; Drug: SCH 530348 (high percentage); 2.5 mg tablet containing ~46% active pharmaceutical ingredient (API) as free base (46+5%) administered orally on the morning of Day 5

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the plasma concentration-time curve from 0 to 72 hours (AUC[0-72h]) of SCH 530348	Up to 72 hours after SCH 530348 dose on Day 5
Maximal plasma concentration (Cmax) of SCH 530348	Up to 72 hours after SCH 530348 dose on Day 5

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants experiencing clinical and laboratory adverse events (AEs)	Up to 2 weeks after last dose

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): December 1, 2010

Study Registration Dates

• First Submitted: May 19, 2011
• First Submitted That Met QC Criteria: May 19, 2011
• First Posted (ESTIMATE): May 23, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): September 29, 2015
• Last Update Submitted That Met QC Criteria: September 28, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Acute Coronary Syndrome; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Pantoprazole; Vorapaxar
• Other Study ID Numbers: P06558