Acute Coronary SyndromePhase 1NCT01358344
A Bioequivalence Study of SCH 530348 2.5 mg Tablets (P06558)
A Phase 1 study testing Pantoprazole, SCH 530348 (high percentage) and SCH 530348 (standard percentage) in people with Acute Coronary Syndrome, run by Merck Sharp & Dohme LLC.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Pantoprazole, SCH 530348 (high percentage) and SCH 530348 (standard percentage)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Dec 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
About this study
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)
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
- Being tested
- Pantoprazole, SCH 530348 (high percentage), SCH 530348 (standard percentage)
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PantoprazoleDrug
40 mg delayed-release tablet administered orally in the morning of Days 1-7
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
SCH 530348 (standard percentage)Drug
2.5 mg tablet containing ~23% API as free base (STANDARD) administered orally on the morning of Day 5
| Study group | Role | What they receive |
|---|---|---|
| Standard Percentage | Experimental | Not described Receives: Drug: Pantoprazole; Drug: SCH 530348 (standard percentage) |
| High Percentage | Experimental | Not described Receives: Drug: Pantoprazole; Drug: SCH 530348 (high percentage) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve from 0 to 72 hours (AUC[0-72h]) of SCH 530348
Measured: Up to 72 hours after SCH 530348 dose on Day 5
Maximal plasma concentration (Cmax) of SCH 530348
Measured: Up to 72 hours after SCH 530348 dose on Day 5
Secondary outcomes (1)
Number of participants experiencing clinical and laboratory adverse events (AEs)
Measured: Up to 2 weeks after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study startAug 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01358344
- Sponsor's protocol ID
- P06558
- Status last verified
- Sep 2015
- First submitted
- 19 May 2011
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01358344
- Acronym / sponsor ID
- P06558
- Conditions
- Acute Coronary Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 23 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Percentage | Experimental | Drug: Pantoprazole, Drug: SCH 530348 (standard percentage) |
| High Percentage | Experimental | Drug: Pantoprazole, Drug: SCH 530348 (high percentage) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pantoprazole40 mg delayed-release tablet administered orally in the morning of Days 1-7 | Drug | High Percentage, Standard Percentage |
| 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 | Drug | High Percentage |
| SCH 530348 (standard percentage)2.5 mg tablet containing ~23% API as free base (STANDARD) administered orally on the morning of Day 5 | Drug | Standard Percentage |
Primary outcome
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
Maximal plasma concentration (Cmax) of SCH 530348
Time frame: Up to 72 hours after SCH 530348 dose on Day 5
1 secondary outcome
Number of participants experiencing clinical and laboratory adverse events (AEs)
Time frame: Up to 2 weeks after last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pantoprazole, SCH 530348 (high percentage) and SCH 530348 (standard percentage) in people with Acute Coronary Syndrome, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2015.