DyslipidemiaPhase 1NCT02676830
Evaluation of Absorption, Metabolism, and Excretion and Estimation of the Absolute Bioavailability of K-312
A Phase 1 study testing K-312 100 mg and K-312 100 ug C14 IV in people with Dyslipidemia, run by Kowa Research Institute, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to Evaluation of absorption, metabolism, and excretion of [14C]-K-312 and estimation of the absolute bioavailability of K-312 in healthy male subjects Read more about this study
- Who is it for?
- Ages 25 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- K-312 100 mg and K-312 100 ug C14 IV
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Apr 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 25 to 45 years
- Men only
- 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 between the ages of 25 and 45 years, inclusive.
- Subject has a body mass index (BMI) of 18.5 to 30 kg/m2, inclusive.
Who cannot join
- Presence of active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment.
- Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of K-312.
- Clinically relevant abnormalities in clinical laboratory parameters, as judged by the Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to Evaluation of absorption, metabolism, and excretion of [14C]-K-312 and estimation of the absolute bioavailability of K-312 in healthy male subjects
- Conditions
- Dyslipidemia
- Being tested
- K-312 100 mg, K-312 100 ug C14 IV
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K-312 100 mgDrug
Single oral dose
K-312 100 ug C14 IVDrug
microtracer dose containing ≤37 kBq (1000 nCi) [14C] given as a 5-ml IV push over 2 minutes
| Study group | Role | What they receive |
|---|---|---|
| K-312 | Experimental | Not described Receives: Drug: K-312 100 mg; Drug: K-312 100 ug C14 IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma-concentration time curve to last measured time point
Measured: 336 hours post-dose
Oral bioavailability based on the ratio of AUC after oral dosing to the AUC after i.v. dosing
Measured: 336 hours post-dose
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 startAug 2014
- Primary completionFeb 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 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
- NCT02676830
- Sponsor's protocol ID
- K-312-1.03US
- Status last verified
- Feb 2016
- First submitted
- 2 Feb 2016
- Last updated
- 18 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Absorption, Metabolism, and Excretion and Estimation of the Absolute Bioavailability of K-312
- ClinicalTrials.gov ID
- NCT02676830
- Acronym / sponsor ID
- K-312-1.03US
- Conditions
- Dyslipidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Kowa Research Institute, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Apr 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 Evaluation of absorption, metabolism, and excretion of [14C]-K-312 and estimation of the absolute bioavailability of K-312 in healthy male subjects
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| K-312 | Experimental | Drug: K-312 100 mg, Drug: K-312 100 ug C14 IV |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subject provides written informed consent before any study-specific evaluation is performed.
- Subject is a healthy adult male between the ages of 25 and 45 years, inclusive.
- Subject has a body mass index (BMI) of 18.5 to 30 kg/m2, inclusive.
Key exclusion criteria (3 listed)
- Presence of active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment.
- Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of K-312.
- Clinically relevant abnormalities in clinical laboratory parameters, as judged by the Investigator.
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-312 100 mgSingle oral dose | Drug | K-312 |
| K-312 100 ug C14 IVmicrotracer dose containing ≤37 kBq (1000 nCi) [14C] given as a 5-ml IV push over 2 minutes | Drug | K-312 |
Primary outcome
Area under the plasma-concentration time curve to last measured time point
Time frame: 336 hours post-dose
Oral bioavailability based on the ratio of AUC after oral dosing to the AUC after i.v. dosing
Time frame: 336 hours post-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 18 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-312 100 mg and K-312 100 ug C14 IV in people with Dyslipidemia, 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 3 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 18 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?
Area under the plasma-concentration time curve to last measured time point (time frame: 336 hours post-dose). 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 18 Feb 2016.