HypercholesterolemiaPhase 1NCT00653913
Evaluation of Potential for Drug Interaction Between SCH 58235 (Ezetimibe) and Pitavastatin (Study P03962)(COMPLETED)
A Phase 1 study testing SCH 58235 and pitavastatin in people with Hypercholesterolemia, run by Organon and Co.
Trial summary
This study was designed to evaluate the pharmacokinetic interaction and safety of coadministration of SCH 58235 (ezetimibe) and pitavastatin in healthy Japanese adult male subjects or adult male subjects having no obvious disease other than high cholesterol levels. Read more about this study
- Who is it for?
- Ages 20 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- SCH 58235 and pitavastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Mar 2004to Sep 2004
- 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 20 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult male subjects meeting all the criteria below or adult male subjects having no obvious disease other than high cholesterol levels.
- Aged 20 years or over and 65 years or below when the informed consent is obtained.
- Weighing 50 kg or over and 80 kg or below on the day of the screening tests, with BMI [Body Mass Index: body weight (kg)/height (m)2] ranging from 16.5 to 27.5.
Who cannot join
- Patients meeting any one of the following conditions are excluded from the study.
- Subjects with the triglyceride value at screening test exceeding 500 mg/dL.
- Subjects with past history of drug allergy (shock, anaphylactic symptom, and angioedema).
- Subjects with past history of alcohol or drug dependence.
- Subjects with past history of mental disorder.
- Subjects positive in the test for HBs antigen, HCV antibody, or HIV antibody or in the serological test for syphilis.
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- Subjects who used any drug within 2 weeks of investigational product administration in Period 1.
- Subjects who have drawn more than 400 mL of blood within 12 weeks before administration day in Period 1.
- Subjects who participated in other study within 16 weeks of investigational product administration in Period 1 and was administered a investigational product.
- Subjects who cannot take contraceptive measures during the study period (from providing informed consent to completion of Period 3 examination)
- Subjects who the investigator judges are inappropriate to participate in the study.
About this study
Official title: Evaluation of Potential for Pharmacokinetic Drug Interaction Between SCH 58235 and Pitavastatin
This study was designed to evaluate the pharmacokinetic interaction and safety of coadministration of SCH 58235 (ezetimibe) and pitavastatin in healthy Japanese adult male subjects or adult male subjects having no obvious disease other than high cholesterol levels.
- Conditions
- Hypercholesterolemia
- Being tested
- SCH 58235, pitavastatin
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCH 58235Drug
Also called Ezetimibe
SCH 58235 10 mg (once daily)
pitavastatinDrug
Pitavastatin 2 mg (once daily)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | SCH 58235 (Period 1) Pitavastatin (Period 2) Coadministration (Period 3) Receives: Drug: SCH 58235; Drug: pitavastatin |
| Group B | Active comparator | SCH 58235 (Period 1) Coadministration (Period 2) Pitavastatin (Period 3) Receives: Drug: SCH 58235; Drug: pitavastatin |
| Group C | Active comparator | Pitavastatin (Period 1) SCH 58235 (Period 2) Coadministration (Period 3) Receives: Drug: SCH 58235; Drug: pitavastatin |
| Group D | Active comparator | Pitavastatin (Period 1) Coadministration (Period 2) SCH 58235 (Period 3) Receives: Drug: SCH 58235; Drug: pitavastatin |
| Group E | Active comparator | Coadministration (Period 1) SCH 58235 (Period 2) Pitavastatin (Period 3) Receives: Drug: SCH 58235; Drug: pitavastatin |
| Group F | Active comparator | Coadministration (Period 1) Pitavastatin (Period 2) SCH 58235 (Period 3) Receives: Drug: SCH 58235; Drug: pitavastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare plasma concentrations of SCH 58235 (ezetimibe) and pitavastatin after administration of each drug alone and in combination, using Cmax and AUC(0-24h).
Measured: Day 7 of each period
Secondary outcomes (2)
Compare plasma concentrations of SCH 58235 (ezetimibe) and pitavastatin administration of each drug alone and in coadministration, using Tmax, plasma concentration 24 h after last dose, and AUC(I).
Measured: Day 7 of each period
Adverse events, laboratory tests results, and vital signs.
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2008 (estimated)
- Study startMar 2004
- Primary completionSep 2004
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00653913
- Sponsor's protocol ID
- P03962
- Status last verified
- Feb 2022
- First submitted
- 31 Mar 2008
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Potential for Pharmacokinetic Drug Interaction Between SCH 58235 and Pitavastatin
- ClinicalTrials.gov ID
- NCT00653913
- Acronym / sponsor ID
- P03962
- Conditions
- Hypercholesterolemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Sep 2004 (actual)
- Study completion
- Sep 2004 (actual)
- First posted
- 7 Apr 2008 (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.
This study was designed to evaluate the pharmacokinetic interaction and safety of coadministration of SCH 58235 (ezetimibe) and pitavastatin in healthy Japanese adult male subjects or adult male subjects having no obvious disease other than high cholesterol levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: SCH 58235, Drug: pitavastatinSCH 58235 (Period 1) Pitavastatin (Period 2) Coadministration (Period 3) |
| Group B | Active comparator | Drug: SCH 58235, Drug: pitavastatinSCH 58235 (Period 1) Coadministration (Period 2) Pitavastatin (Period 3) |
| Group C | Active comparator | Drug: SCH 58235, Drug: pitavastatinPitavastatin (Period 1) SCH 58235 (Period 2) Coadministration (Period 3) |
| Group D | Active comparator | Drug: SCH 58235, Drug: pitavastatinPitavastatin (Period 1) Coadministration (Period 2) SCH 58235 (Period 3) |
| Group E | Active comparator | Drug: SCH 58235, Drug: pitavastatinCoadministration (Period 1) SCH 58235 (Period 2) Pitavastatin (Period 3) |
| Group F | Active comparator | Drug: SCH 58235, Drug: pitavastatinCoadministration (Period 1) Pitavastatin (Period 2) SCH 58235 (Period 3) |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adult male subjects meeting all the criteria below or adult male subjects having no obvious disease other than high cholesterol levels.
- Aged 20 years or over and 65 years or below when the informed consent is obtained.
- Weighing 50 kg or over and 80 kg or below on the day of the screening tests, with BMI [Body Mass Index: body weight (kg)/height (m)2] ranging from 16.5 to 27.5.
Key exclusion criteria (11 listed)
- Patients meeting any one of the following conditions are excluded from the study.
- Subjects with the triglyceride value at screening test exceeding 500 mg/dL.
- Subjects with past history of drug allergy (shock, anaphylactic symptom, and angioedema).
- Subjects with past history of alcohol or drug dependence.
- Subjects with past history of mental disorder.
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 |
|---|---|---|
| SCH 58235Also: EzetimibeSCH 58235 10 mg (once daily) | Drug | Group A, Group B, Group C, Group D, Group E, Group F |
| pitavastatinPitavastatin 2 mg (once daily) | Drug | Group A, Group B, Group C, Group D, Group E, Group F |
Primary outcome
Compare plasma concentrations of SCH 58235 (ezetimibe) and pitavastatin after administration of each drug alone and in combination, using Cmax and AUC(0-24h).
Time frame: Day 7 of each period
2 secondary outcomes
Compare plasma concentrations of SCH 58235 (ezetimibe) and pitavastatin administration of each drug alone and in coadministration, using Tmax, plasma concentration 24 h after last dose, and AUC(I).
Time frame: Day 7 of each period
Adverse events, laboratory tests results, and vital signs.
Time frame: Throughout study
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 16 Feb 2022.
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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 SCH 58235 and pitavastatin in people with Hypercholesterolemia, run by Organon and Co.
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 3 inclusion and 11 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 16 Feb 2022. 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?
Compare plasma concentrations of SCH 58235 (ezetimibe) and pitavastatin after administration of each drug alone and in combination, using Cmax and AUC(0-24h). (time frame: Day 7 of each period). 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 16 Feb 2022.