HealthyPhase 1NCT03712241
Evaluate the Safety, Tolerability, & Pharmacokinetics of K-285 Compared With Indomethacin Capsule in Healthy Adults
A Phase 1 study testing K-285 and Indomethacin in people with Healthy, run by Kowa Research Institute, Inc. at 1 site in United States.
Trial summary
This study is to compare the PK parameters of multiple doses and applications of K-285 with a single dose of indomethacin capsule. 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?
- K-285 and Indomethacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2018to 6 Jan 2019
- 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 aged 18 to 45 years, inclusive.
- Subject has a BMI of 18 to 30 kg/m2, inclusive.
- Subject meets all inclusion criteria outlined in the clinical study protocol.
Who cannot join
- Subject has abnormal findings or assessments that are clinically noteworthy at Screening or Admission (Day -1).
- Subject has a supine blood pressure after resting for 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 50 mm Hg diastolic at Screening or Admission (Day -1).
- Subject has a supine heart rate after resting for 5 minutes that is outside the range of 40 to 100 beats per minute at Screening or Admission (Day -1).
- Subject does not meet any exclusion criteria outlined in the clinical study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-label, Randomized, 4-period Crossover Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of K-285 Compared With a Single Oral Dose of Indomethacin Capsule in Healthy Adult Volunteers
This study is to compare the PK parameters of multiple doses and applications of K-285 with a single dose of indomethacin capsule.
- Conditions
- Healthy
- Being tested
- K-285, Indomethacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K-285Drug
Topical
IndomethacinDrug
Capsule
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | K-285 dose/application method A Receives: Drug: K-285 |
| Treatment B | Experimental | K-285 dose/application method B Receives: Drug: K-285 |
| Treatment C | Experimental | K-285 dose/application method C Receives: Drug: K-285 |
| Treatment D | Active comparator | Indomethacin capsule Receives: Drug: Indomethacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax)
Measured: Day 2 to Day 7 of Periods 1, 2, and 3 and Day 1 of Period 4
Area under the plasma versus concentration time curve (AUC)
Measured: Day 2 to Day 7 of Periods 1, 2, and 3 and Day 1 of Period 4
Secondary outcomes (1)
Number of participants with treatment-related adverse events
Measured: Through study completion approximately 33 to 38 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start4 Oct 2018
- Primary completion6 Jan 2019
- Study completion6 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT03712241
- Sponsor's protocol ID
- K-285-101
- Status last verified
- Jan 2019
- First submitted
- 1 Oct 2018
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Randomized, 4-period Crossover Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of K-285 Compared With a Single Oral Dose of Indomethacin Capsule in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT03712241
- Acronym / sponsor ID
- K-285-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Kowa Research Institute, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Oct 2018 (actual)
- Primary completion
- 6 Jan 2019 (actual)
- Study completion
- 6 Jan 2019 (actual)
- First posted
- 19 Oct 2018 (actual)
- 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 is to compare the PK parameters of multiple doses and applications of K-285 with a single dose of indomethacin capsule.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: K-285K-285 dose/application method A |
| Treatment B | Experimental | Drug: K-285K-285 dose/application method B |
| Treatment C | Experimental | Drug: K-285K-285 dose/application method C |
| Treatment D | Active comparator | Drug: IndomethacinIndomethacin capsule |
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 aged 18 to 45 years, inclusive.
- Subject has a BMI of 18 to 30 kg/m2, inclusive.
- Subject meets all inclusion criteria outlined in the clinical study protocol.
Key exclusion criteria (4 listed)
- Subject has abnormal findings or assessments that are clinically noteworthy at Screening or Admission (Day -1).
- Subject has a supine blood pressure after resting for 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 50 mm Hg diastolic at Screening or Admission (Day -1).
- Subject has a supine heart rate after resting for 5 minutes that is outside the range of 40 to 100 beats per minute at Screening or Admission (Day -1).
- Subject does not meet any exclusion criteria outlined in the clinical study protocol.
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-285Topical | Drug | Treatment A, Treatment B, Treatment C |
| IndomethacinCapsule | Drug | Treatment D |
Primary outcome
Maximum Plasma Concentration (Cmax)
Time frame: Day 2 to Day 7 of Periods 1, 2, and 3 and Day 1 of Period 4
Area under the plasma versus concentration time curve (AUC)
Time frame: Day 2 to Day 7 of Periods 1, 2, and 3 and Day 1 of Period 4
1 secondary outcome
Number of participants with treatment-related adverse events
Time frame: Through study completion approximately 33 to 38 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 17 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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-285 and Indomethacin 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 4 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 17 Jan 2019. 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?
Maximum Plasma Concentration (Cmax) (time frame: Day 2 to Day 7 of Periods 1, 2, and 3 and Day 1 of Period 4). 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 17 Jan 2019.