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

Acute Coronary Syndrome Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01358344
• Other study ID #: P06558
• Status: Completed
• Phase: Phase 1
• First received: May 19, 2011
• Last updated: September 28, 2015
• Start date: August 2010
• Est. completion date: December 2010

Study information

• Verified date: September 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

Drug:
• Pantoprazole
40 mg delayed-release tablet administered orally in the morning of Days 1-7
• 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
• SCH 530348 (standard percentage)
2.5 mg tablet containing ~23% API as free base (STANDARD) administered orally on the morning of Day 5

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Maximal plasma concentration (Cmax) of SCH 530348		Up to 72 hours after SCH 530348 dose on Day 5	No
Secondary	Number of participants experiencing clinical and laboratory adverse events (AEs)		Up to 2 weeks after last dose	No