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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01358344
Recruitment Status : Completed
First Posted : May 23, 2011
Last Update Posted : September 29, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: Pantoprazole Drug: SCH 530348 (high percentage) Drug: SCH 530348 (standard percentage) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : August 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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

Secondary Outcome Measures :
  1. Number of participants experiencing clinical and laboratory adverse events (AEs) [ Time Frame: Up to 2 weeks after last dose ]

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01358344     History of Changes
Other Study ID Numbers: P06558
First Posted: May 23, 2011    Key Record Dates
Last Update Posted: September 29, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors