HyperlipidemiaPhase 1NCT02634034
A Comparison Study to Evaluate the Pharmacokinetics and Safety of NK-104-CR in Healthy Adult Volunteers
A Phase 1 study testing A: NK-104-CR 8 mg, B: Pitavastatin IR 4 mg and C: Pitavastatin IR 8 mg in people with Hyperlipidemia, run by Kowa Research Institute, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to compare the pharmacokinetics and safety of a controlled release (CR) version of pitavastatin (also referred to as NK-104) to immediate release (IR) pitavastatin in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- A: NK-104-CR 8 mg, B: Pitavastatin IR 4 mg and C: Pitavastatin IR 8 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Dec 2015
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject provides written informed consent before any study-specific evaluation is performed.
- Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive.
- Subject has no clinically significant abnormalities on the basis of medical history, physical examination findings, or vital sign measurements, as judged by the Investigator.
- Subject is able and willing to comply with the protocol and study procedures.
Who cannot join
- Subject is a woman who is pregnant or breastfeeding.
- Subject has clinically relevant abnormalities in the screening or check-in assessments.
- Subject has received an investigational drug within 30 days before the first dose of study drug.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the pharmacokinetics and safety of a controlled release (CR) version of pitavastatin (also referred to as NK-104) to immediate release (IR) pitavastatin in healthy adult volunteers.
- Conditions
- Hyperlipidemia
- Being tested
- A: NK-104-CR 8 mg, B: Pitavastatin IR 4 mg, C: Pitavastatin IR 8 mg
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A: NK-104-CR 8 mgDrug
NK-104-CR 8 mg (Controlled Release single 8-mg tablet)
B: Pitavastatin IR 4 mgDrug
Pitavastatin IR 4 mg (Immediate Release single 4-mg tablet)
C: Pitavastatin IR 8 mgDrug
Pitavastatin IR 8 mg (Immediate Release two 4-mg tablets)
| Study group | Role | What they receive |
|---|---|---|
| NK-104-CR (8mg), Pitavastatin IR (4mg), Pitavastatin IR (8mg) | Experimental | Not described Receives: Drug: A: NK-104-CR 8 mg; Drug: B: Pitavastatin IR 4 mg; Drug: C: Pitavastatin IR 8 mg |
| Pitavastatin IR (4mg), Pitavastatin IR (8mg), NK-104-CR (8mg) | Experimental | Not described Receives: Drug: A: NK-104-CR 8 mg; Drug: B: Pitavastatin IR 4 mg; Drug: C: Pitavastatin IR 8 mg |
| Pitavastatin IR (8mg), NK-104-CR (8mg), Pitavastatin IR (4mg) | Experimental | Not described Receives: Drug: A: NK-104-CR 8 mg; Drug: B: Pitavastatin IR 4 mg; Drug: C: Pitavastatin IR 8 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve
Area Under the Curve 0 to tau
Measured: 0 to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kowa Research Institute, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02634034
- Sponsor's protocol ID
- NK-104-CR-1.01US
- Status last verified
- Jan 2016
- First submitted
- 10 Dec 2015
- Last updated
- 11 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Study to Evaluate the Pharmacokinetics and Safety of NK-104-CR in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT02634034
- Acronym / sponsor ID
- NK-104-CR-1.01US
- Conditions
- Hyperlipidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Kowa Research Institute, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Dec 2015 (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 to compare the pharmacokinetics and safety of a controlled release (CR) version of pitavastatin (also referred to as NK-104) to immediate release (IR) pitavastatin in healthy adult volunteers.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NK-104-CR (8mg), Pitavastatin IR (4mg), Pitavastatin IR (8mg) | Experimental | Drug: A: NK-104-CR 8 mg, Drug: B: Pitavastatin IR 4 mg, Drug: C: Pitavastatin IR 8 mg |
| Pitavastatin IR (4mg), Pitavastatin IR (8mg), NK-104-CR (8mg) | Experimental | Drug: A: NK-104-CR 8 mg, Drug: B: Pitavastatin IR 4 mg, Drug: C: Pitavastatin IR 8 mg |
| Pitavastatin IR (8mg), NK-104-CR (8mg), Pitavastatin IR (4mg) | Experimental | Drug: A: NK-104-CR 8 mg, Drug: B: Pitavastatin IR 4 mg, Drug: C: Pitavastatin IR 8 mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject provides written informed consent before any study-specific evaluation is performed.
- Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive.
- Subject has no clinically significant abnormalities on the basis of medical history, physical examination findings, or vital sign measurements, as judged by the Investigator.
- Subject is able and willing to comply with the protocol and study procedures.
Key exclusion criteria (3 listed)
- Subject is a woman who is pregnant or breastfeeding.
- Subject has clinically relevant abnormalities in the screening or check-in assessments.
- Subject has received an investigational drug within 30 days 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 |
|---|---|---|
| A: NK-104-CR 8 mgNK-104-CR 8 mg (Controlled Release single 8-mg tablet) | Drug | NK-104-CR (8mg), Pitavastatin IR (4mg), Pitavastatin IR (8mg), Pitavastatin IR (4mg), Pitavastatin IR (8mg), NK-104-CR (8mg), Pitavastatin IR (8mg), NK-104-CR (8mg), Pitavastatin IR (4mg) |
| B: Pitavastatin IR 4 mgPitavastatin IR 4 mg (Immediate Release single 4-mg tablet) | Drug | NK-104-CR (8mg), Pitavastatin IR (4mg), Pitavastatin IR (8mg), Pitavastatin IR (4mg), Pitavastatin IR (8mg), NK-104-CR (8mg), Pitavastatin IR (8mg), NK-104-CR (8mg), Pitavastatin IR (4mg) |
| C: Pitavastatin IR 8 mgPitavastatin IR 8 mg (Immediate Release two 4-mg tablets) | Drug | NK-104-CR (8mg), Pitavastatin IR (4mg), Pitavastatin IR (8mg), Pitavastatin IR (4mg), Pitavastatin IR (8mg), NK-104-CR (8mg), Pitavastatin IR (8mg), NK-104-CR (8mg), Pitavastatin IR (4mg) |
Primary outcome
Area Under the Curve
Time frame: 0 to 48 hours
Area Under the Curve 0 to tau
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 11 Jan 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing A: NK-104-CR 8 mg, B: Pitavastatin IR 4 mg and C: Pitavastatin IR 8 mg in people with Hyperlipidemia, 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 4 inclusion and 3 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 11 Jan 2016. 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 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 Curve (time frame: 0 to 48 hours). 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 11 Jan 2016.