A Bioequivalence Study of SCH 530348 2.5 mg Tablets (P06558)
Overview[ - collapse ][ - ]
| Purpose | 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 | Acute Coronary Syndrome |
| Intervention | Drug: Pantoprazole Drug: SCH 530348 (high percentage) Drug: SCH 530348 (standard percentage) |
| Phase | Phase 1 |
| Sponsor | Merck Sharp & Dohme Corp. |
| Responsible Party | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier | NCT01358344 |
| First Received | May 19, 2011 |
| Last Updated | October 25, 2013 |
| Last verified | October 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | May 19, 2011 |
|---|---|
| Last Updated Date | October 25, 2013 |
| Start Date | August 2010 |
| Estimated Primary Completion Date | December 2010 |
| Current Primary Outcome Measures |
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| Current Secondary Outcome Measures | Number of participants experiencing clinical and laboratory adverse events (AEs) [Time Frame: Up to 2 weeks after last dose] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
| 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) |
| 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 1 |
| Study Design | Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Acute Coronary Syndrome |
| Intervention | 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 Other Names: VorapaxarDrug: SCH 530348 (standard percentage) 2.5 mg tablet containing ~23% API as free base (STANDARD) administered orally on the morning of Day 5 Other Names: Vorapaxar |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 173 |
| Estimated Completion Date | December 2010 |
| Estimated Primary Completion Date | December 2010 |
| 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Not Provided |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01358344 |
|---|---|
| Other Study ID Numbers | P06558 |
| Has Data Monitoring Committee | No |
| Information Provided By | Merck Sharp & Dohme Corp. |
| Study Sponsor | Merck Sharp & Dohme Corp. |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | October 2013 |