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

May 19, 2011
October 25, 2013
August 2010
December 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01358344 on ClinicalTrials.gov Archive Site
Number of participants experiencing clinical and laboratory adverse events (AEs) [ Time Frame: Up to 2 weeks after last dose ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Coronary Syndrome
  • 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
  • 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: Standard percentage
    Interventions:
    • Drug: Pantoprazole
    • Drug: SCH 530348 (standard percentage)
  • Experimental: High percentage
    Interventions:
    • Drug: Pantoprazole
    • Drug: SCH 530348 (high percentage)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
173
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01358344
P06558
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP