Back to resultsA Bioequivalence Study of SCH 530348 2.5 mg Tablets (P06558)
Primary Purpose
Acute Coronary Syndrome
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Pantoprazole
SCH 530348 (high percentage)
SCH 530348 (standard percentage)
Sponsored by
About this trial
This is an interventional treatment trial for Acute Coronary Syndrome
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Standard Percentage
High Percentage
Arm Description
Outcomes
Primary Outcome Measures
Area under the plasma concentration-time curve from 0 to 72 hours (AUC[0-72h]) of SCH 530348
Maximal plasma concentration (Cmax) of SCH 530348
Secondary Outcome Measures
Number of participants experiencing clinical and laboratory adverse events (AEs)
Full Information
NCT ID
NCT01358344
First Posted
May 19, 2011
Last Updated
September 28, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01358344
Brief Title
A Bioequivalence Study of SCH 530348 2.5 mg Tablets (P06558)
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 Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
173 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Percentage
Arm Type
Experimental
Arm Title
High Percentage
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pantoprazole
Intervention Description
40 mg delayed-release tablet administered orally in the morning of Days 1-7
Intervention Type
Drug
Intervention Name(s)
SCH 530348 (high percentage)
Intervention Description
2.5 mg tablet containing ~46% active pharmaceutical ingredient (API) as free base (46+5%) administered orally on the morning of Day 5
Intervention Type
Drug
Intervention Name(s)
SCH 530348 (standard percentage)
Intervention Description
2.5 mg tablet containing ~23% API as free base (STANDARD) administered orally on the morning of Day 5
Primary Outcome Measure Information:
Title
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
Title
Maximal plasma concentration (Cmax) of SCH 530348
Time Frame
Up to 72 hours after SCH 530348 dose on Day 5
Secondary Outcome Measure Information:
Title
Number of participants experiencing clinical and laboratory adverse events (AEs)
Time Frame
Up to 2 weeks after last dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
A Bioequivalence Study of SCH 530348 2.5 mg Tablets (P06558)
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