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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01358344
First received: May 19, 2011
Last updated: October 25, 2013
Last verified: October 2013
  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 Intervention Phase
Acute Coronary Syndrome
Drug: Pantoprazole
Drug: SCH 530348 (high percentage)
Drug: SCH 530348 (standard percentage)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Maximal plasma concentration (Cmax) of SCH 530348 [ Time Frame: Up to 72 hours after SCH 530348 dose on Day 5 ] [ Designated as safety issue: No ]

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 ]

Enrollment: 173
Study Start Date: August 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Vorapaxar
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
Other Name: Vorapaxar

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01358344     History of Changes
Other Study ID Numbers: P06558
Study First Received: May 19, 2011
Last Updated: October 25, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Pantoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014