Safety and TolerabilityPhase 1NCT01952548
Study Comparing the Pharmacokinetics, Pharmacodynamics, and Safety of K-312 in Healthy Adult Volunteers
A Phase 1 study testing K-312 in people with Safety and Tolerability, run by Kowa Research Institute, Inc. at 1 site in United States.
Trial summary
This study will test single doses of the study drug in increasing amounts to see if it is safe. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Safety and Tolerability
- What is being tested?
- K-312
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- May 2013to Dec 2013
- 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
- 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 32 kg/m2, inclusive.
Who cannot join
- Subject is a woman who is of childbearing potential or is breastfeeding.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
This study will test single doses of the study drug in increasing amounts to see if it is safe.
- Conditions
- Safety and Tolerability
- Being tested
- K-312, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K-312Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 Active | Experimental | Not described Receives: Drug: K-312 |
| Dose 2 Active | Experimental | Not described Receives: Drug: K-312 |
| Dose 3 Active | Experimental | Not described Receives: Drug: K-312 |
| Dose 4 Active | Experimental | Not described Receives: Drug: K-312 |
| Dose 5 Active | Experimental | Not described Receives: Drug: K-312 |
| Dose 6 Active | Experimental | Not described Receives: Drug: K-312 |
| Dose 7 Active | Experimental | Not described Receives: Drug: K-312 |
| Dose 1 Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Dose 2 Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Dose 3 Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Dose 4 Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Dose 5 Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Dose 6 Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Dose 7 Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Measured: 10 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and TolerabilityStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
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
- NCT01952548
- Sponsor's protocol ID
- K-312-1.01US
- Status last verified
- Dec 2013
- First submitted
- 19 Sep 2013
- Last updated
- 31 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Comparing the Pharmacokinetics, Pharmacodynamics, and Safety of K-312 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01952548
- Acronym / sponsor ID
- K-312-1.01US
- Conditions
- Safety and Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Kowa Research Institute, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Dec 2013 (actual)
- First posted
- 30 Sep 2013 (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 will test single doses of the study drug in increasing amounts to see if it is safe.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Dose 1 Active | Experimental | Drug: K-312 |
| Dose 2 Active | Experimental | Drug: K-312 |
| Dose 3 Active | Experimental | Drug: K-312 |
| Dose 4 Active | Experimental | Drug: K-312 |
| Dose 5 Active | Experimental | Drug: K-312 |
| Dose 6 Active | Experimental | Drug: K-312 |
| Dose 7 Active | Experimental | Drug: K-312 |
| Dose 1 Placebo | Placebo comparator | Drug: Placebo |
| Dose 2 Placebo | Placebo comparator | Drug: Placebo |
| Dose 3 Placebo | Placebo comparator | Drug: Placebo |
| Dose 4 Placebo | Placebo comparator | Drug: Placebo |
| Dose 5 Placebo | Placebo comparator | Drug: Placebo |
| Dose 6 Placebo | Placebo comparator | Drug: Placebo |
| Dose 7 Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- 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 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 32 kg/m2, inclusive.
Key exclusion criteria (2 listed)
- Subject is a woman who is of childbearing potential or is breastfeeding.
- 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.
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 | Drug | Dose 1 Active, Dose 2 Active, Dose 3 Active, Dose 4 Active, Dose 5 Active, Dose 6 Active, Dose 7 Active |
| Placebo | Drug | Dose 1 Placebo, Dose 2 Placebo, Dose 3 Placebo, Dose 4 Placebo, Dose 5 Placebo, Dose 6 Placebo, Dose 7 Placebo |
Primary outcome
Adverse Events
Time frame: 10 Days
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 31 Dec 2013.
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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 in people with Safety and Tolerability, 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 2 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 31 Dec 2013. 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. Some participants in this study may receive a placebo. 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?
Adverse Events (time frame: 10 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 31 Dec 2013.