Acute Coronary Syndrome
Conditions
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.
Interventions
DRUGPantoprazole
40 mg delayed-release tablet administered orally in the morning of Days 1-7
DRUGSCH 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
DRUGSCH 530348 (standard percentage)
2.5 mg tablet containing \ 23% API as free base (STANDARD) administered orally on the morning of Day 5
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Number of participants experiencing clinical and laboratory adverse events (AEs) | Up to 2 weeks after last dose |
Outcome results
None listed