HealthyPhase 4NCT01422382
Drug-Drug Interaction of Cardizem LA (Diltiazem Hydrochloride) on Pitavastatin
A Phase 4 study testing Pitavastatin (NK-104) and Diltiazem (Cardizem LA) 240 mg QD in people with Healthy, run by Kowa Research Institute, Inc. at 1 site in United States.
Trial summary
This is a Phase 4, single-center, open-label, fixed-sequence, multiple-dose, 2-way drug-drug interaction study. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pitavastatin (NK-104) and Diltiazem (Cardizem LA) 240 mg QD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Jul 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult male or female volunteer aged 18 to 45 years, inclusive.
- Subject has a body mass index of 18 to 30 kg/m2, inclusive.
- Subject has normal hematology, serum chemistry, and urinalysis test results.
- Subject is able and willing to abstain from alcohol, grapefruit-containing foods or beverages, caffeine, or caffeine-containing products, St John's wort, and herbal supplements for 4 days before Day 1 and until after completion of this study.
- Subject is a nonsmoker or has quit smoking at least 6 months before the first dose of study drug and until after study completion.
Who cannot join
- Subject has had any surgery of the gastrointestinal tract likely to affect drug absorption, distribution, metabolism, or excretion.
- Subject has had a previous allergy or intolerance to treatment with pitavastatin, diltiazem, or any drugs in these classes.
- Subject has a history of drug or alcohol abuse.
- Subject has had a clinically significant illness within 4 weeks before the first dose of study drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drug-Drug Interaction Study to Assess the Effects of Steady-State Cardizem LA (Diltiazem Hydrochloride) and Steady-State Pitavastatin on Their Respective Pharmacokinetics in Healthy Adult Volunteers
This is a Phase 4, single-center, open-label, fixed-sequence, multiple-dose, 2-way drug-drug interaction study.
Read the detailed description
Each subject will qualify for entry into the study not more than 30 days prior to admission into the clinical unit. Subjects will check into the clinical unit on Day -1 for baseline assessments. During the treatment period, each subject will receive a once-daily dose of pitavastatin 4 mg on Days 1 through 5 and on Days 11 through 15 and a once-daily dose of diltiazem 240 mg on Days 6 through 15. Subjects will fast overnight for at least 8 hours before dosing and will remain fasted until 4 hours after dosing on the morning of Days 5, 10, and 15.
- Conditions
- Healthy
- Being tested
- Pitavastatin (NK-104), Diltiazem (Cardizem LA) 240 mg QD
- Keywords
- Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pitavastatin (NK-104)Drug
Also called Livalo
pitavastatin (NK-104) 4 mg once daily (QD)
Diltiazem (Cardizem LA) 240 mg QDDrug
Diltiazem (Cardizem LA) 240 mg QD
| Study group | Role | What they receive |
|---|---|---|
| All Subjects | Experimental | There was 1 treatment period, with each subject receiving a once-daily dose of pitavastatin 4 mg on Days 1 through 5 and on Days 11 through 15 and a once-daily dose of diltiazem 240 mg on Days 6 through 15 Receives: Drug: Pitavastatin (NK-104); Drug: Diltiazem (Cardizem LA) 240 mg QD |
What is being measured
The primary outcome is the main question the study is designed to answer.
NK-104 AUC
Measured: 15 Days
Secondary outcomes (1)
Number of Participants With at Least One Adverse Event.
Measured: 24 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies 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 4
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kowa Research Institute, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roger Morgan, MD, FACS, Study director, Kowa Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422382
- Sponsor's protocol ID
- NK-104-4.07US
- Status last verified
- Jul 2012
- First submitted
- 22 Aug 2011
- Last updated
- 13 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug-Drug Interaction Study to Assess the Effects of Steady-State Cardizem LA (Diltiazem Hydrochloride) and Steady-State Pitavastatin on Their Respective Pharmacokinetics in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01422382
- Acronym / sponsor ID
- NK-104-4.07US
- Conditions
- Healthy
- Keywords
- Healthy Volunteers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Kowa Research Institute, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 24 Aug 2011 (estimated)
- Results
- Posted 12 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 4, single-center, open-label, fixed-sequence, multiple-dose, 2-way drug-drug interaction study.
Detailed description
Each subject will qualify for entry into the study not more than 30 days prior to admission into the clinical unit. Subjects will check into the clinical unit on Day -1 for baseline assessments. During the treatment period, each subject will receive a once-daily dose of pitavastatin 4 mg on Days 1 through 5 and on Days 11 through 15 and a once-daily dose of diltiazem 240 mg on Days 6 through 15. Subjects will fast overnight for at least 8 hours before dosing and will remain fasted until 4 hours after dosing on the morning of Days 5, 10, and 15.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Subjects | Experimental | Drug: Pitavastatin (NK-104), Drug: Diltiazem (Cardizem LA) 240 mg QDThere was 1 treatment period, with each subject receiving a once-daily dose of pitavastatin 4 mg on Days 1 through 5 and on Days 11 through 15 and a once-daily dose of diltiazem 240 mg on Days 6 through 15 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adult male or female volunteer aged 18 to 45 years, inclusive.
- Subject has a body mass index of 18 to 30 kg/m2, inclusive.
- Subject has normal hematology, serum chemistry, and urinalysis test results.
- Subject is able and willing to abstain from alcohol, grapefruit-containing foods or beverages, caffeine, or caffeine-containing products, St John's wort, and herbal supplements for 4 days before Day 1 and until after completion of this study.
- Subject is a nonsmoker or has quit smoking at least 6 months before the first dose of study drug and until after study completion.
Key exclusion criteria (4 listed)
- Subject has had any surgery of the gastrointestinal tract likely to affect drug absorption, distribution, metabolism, or excretion.
- Subject has had a previous allergy or intolerance to treatment with pitavastatin, diltiazem, or any drugs in these classes.
- Subject has a history of drug or alcohol abuse.
- Subject has had a clinically significant illness within 4 weeks before the first dose of study drug.
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 |
|---|---|---|
| Pitavastatin (NK-104)Also: Livalopitavastatin (NK-104) 4 mg once daily (QD) | Drug | All Subjects |
| Diltiazem (Cardizem LA) 240 mg QDDiltiazem (Cardizem LA) 240 mg QD | Drug | All Subjects |
Primary outcome
NK-104 AUC
Time frame: 15 Days
1 secondary outcome
Number of Participants With at Least One Adverse Event.
Time frame: 24 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Roger Morgan, MD, FACS study director
Kowa Research Institute, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pitavastatin (NK-104) and Diltiazem (Cardizem LA) 240 mg QD in people with Healthy, run by Kowa Research Institute, Inc. at 1 site in United States.
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 5 inclusion and 4 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 13 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
NK-104 AUC (time frame: 15 Days). 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 13 Jul 2012.