HyperlipidemiaPhase 1NCT02676596
Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of K-312 in Healthy Subjects
A Phase 1 study testing K-312 10 mg QD, K-312 25 mg QD and K-312 50 mg QD 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 investigate the safety tolerability, and PK profile of K-312 and its metabolites in healthy Japanese and non-Japanese adults. 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?
- K-312 10 mg QD, K-312 25 mg QD and K-312 50 mg QD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jan 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 a female of non-childbearing potential between the ages of 18 and 45 years, inclusive.
- Subject has a body mass index of 18.5 to 30 kg/m2, inclusive.
- Subject has hematology, coagulation, serum chemistry, and urinalysis test results within the reference ranges or showing no clinically relevant deviations, as judged by the Investigator.
Who cannot join
- Subject has the presence of an active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment.
- Subject has any surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of K-312. Cholecystectomy is permitted if there are no postcholecystectomy gastrointestinal symptoms.
- Subject has clinically relevant abnormalities in clinical laboratory parameters.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the safety tolerability, and PK profile of K-312 and its metabolites in healthy Japanese and non-Japanese adults.
- Conditions
- Hyperlipidemia
- Being tested
- K-312 10 mg QD, K-312 25 mg QD, K-312 50 mg QD, K-312 100 mg QD, K-312 200 mg QD
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K-312 10 mg QDDrug
K-312 25 mg QDDrug
K-312 50 mg QDDrug
K-312 100 mg QDDrug
K-312 200 mg QDDrug
K-312 400 mg QDDrug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Other | Japanese and Non-Japanese subjects receiving K-312 50 mg QD Receives: Drug: K-312 50 mg QD; Other: Placebo |
| Cohort 2 | Other | Japanese and Non-Japanese subjects receiving K-312 100 mg QD Receives: Drug: K-312 100 mg QD; Other: Placebo |
| Cohort 3 | Other | Japanese and Non-Japanese subjects receiving K-312 200 mg QD Receives: Drug: K-312 200 mg QD; Other: Placebo |
| Cohort 4 | Other | Japanese and Non-Japanese subjects receiving K-312 400 mg QD Receives: Drug: K-312 400 mg QD; Other: Placebo |
| Cohort 5 | Other | Japanese and Non-Japanese subjects receiving K-312 25 mg QD Receives: Drug: K-312 25 mg QD; Other: Placebo |
| Cohort 6 | Other | Japanese and Non-Japanese subjects receiving K-312 10 mg QD Receives: Drug: K-312 10 mg QD; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
CETP activity
Measured: Days 1, 3, 6, 11, 16, 21, 27 and 30
Area under the plasma concentration
Measured: Days 1 and 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startApr 2014
- Primary completionNov 2014
- Study completionJan 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 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
- NCT02676596
- Sponsor's protocol ID
- K-312-1.02US
- Status last verified
- Feb 2016
- First submitted
- 2 Feb 2016
- Last updated
- 12 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of K-312 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02676596
- Acronym / sponsor ID
- K-312-1.02US
- Conditions
- Hyperlipidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kowa Research Institute, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 8 Feb 2016 (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 investigate the safety tolerability, and PK profile of K-312 and its metabolites in healthy Japanese and non-Japanese adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Other | Drug: K-312 50 mg QD, Other: PlaceboJapanese and Non-Japanese subjects receiving K-312 50 mg QD |
| Cohort 2 | Other | Drug: K-312 100 mg QD, Other: PlaceboJapanese and Non-Japanese subjects receiving K-312 100 mg QD |
| Cohort 3 | Other | Drug: K-312 200 mg QD, Other: PlaceboJapanese and Non-Japanese subjects receiving K-312 200 mg QD |
| Cohort 4 | Other | Drug: K-312 400 mg QD, Other: PlaceboJapanese and Non-Japanese subjects receiving K-312 400 mg QD |
| Cohort 5 | Other | Drug: K-312 25 mg QD, Other: PlaceboJapanese and Non-Japanese subjects receiving K-312 25 mg QD |
| Cohort 6 | Other | Drug: K-312 10 mg QD, Other: PlaceboJapanese and Non-Japanese subjects receiving K-312 10 mg QD |
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 a female of non-childbearing potential between the ages of 18 and 45 years, inclusive.
- Subject has a body mass index of 18.5 to 30 kg/m2, inclusive.
- Subject has hematology, coagulation, serum chemistry, and urinalysis test results within the reference ranges or showing no clinically relevant deviations, as judged by the Investigator.
Key exclusion criteria (3 listed)
- Subject has the presence of an active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment.
- Subject has any surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of K-312. Cholecystectomy is permitted if there are no postcholecystectomy gastrointestinal symptoms.
- Subject has clinically relevant abnormalities in clinical laboratory parameters.
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 |
|---|---|---|
| K-312 10 mg QD | Drug | Cohort 6 |
| K-312 25 mg QD | Drug | Cohort 5 |
| K-312 50 mg QD | Drug | Cohort 1 |
| K-312 100 mg QD | Drug | Cohort 2 |
| K-312 200 mg QD | Drug | Cohort 3 |
| K-312 400 mg QD | Drug | Cohort 4 |
| Placebo | Other | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
Primary outcome
CETP activity
Time frame: Days 1, 3, 6, 11, 16, 21, 27 and 30
Area under the plasma concentration
Time frame: Days 1 and 21
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 12 Feb 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 K-312 10 mg QD, K-312 25 mg QD and K-312 50 mg QD 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 12 Feb 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?
CETP activity (time frame: Days 1, 3, 6, 11, 16, 21, 27 and 30). 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 12 Feb 2016.