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

NCT01358344 | Completed Phase 1

• 1 other identifier: P06558
• Study Type: interventional
• Target: 173
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (2)

• Area under the plasma concentration-time curve from 0 to 72 hours (AUC[0-72h]) of SCH 530348

  Up to 72 hours after SCH 530348 dose on Day 5

• Maximal plasma concentration (Cmax) of SCH 530348

  Up to 72 hours after SCH 530348 dose on Day 5

Secondary Outcomes (1)

• Number of participants experiencing clinical and laboratory adverse events (AEs)

  Up to 2 weeks after last dose

Study Arms (2)

Standard Percentage

EXPERIMENTAL

Drug: Pantoprazole; Drug: SCH 530348 (standard percentage)

High Percentage

EXPERIMENTAL

Drug: Pantoprazole; Drug: SCH 530348 (high percentage)

Interventions

Pantoprazole DRUG

40 mg delayed-release tablet administered orally in the morning of Days 1-7

High Percentage; Standard Percentage

SCH 530348 (high percentage) DRUG

2.5 mg tablet containing \~46% active pharmaceutical ingredient (API) as free base (46+5%) administered orally on the morning of Day 5

High Percentage

SCH 530348 (standard percentage) DRUG

2.5 mg tablet containing \~23% API as free base (STANDARD) administered orally on the morning of Day 5

Standard Percentage

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Pantoprazole; vorapaxar

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2011
• First Posted: May 23, 2011
• Study Start: August 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: September 29, 2015

Record last verified: 2015-09