HealthyPhase 1NCT03702673
Compare the Pharmacokinetic of K-877 Controlled Release (CR) and Immediate Release (IR) Tablets in Healthy Adults.
A Phase 1 study testing K-877 CR Tablet A, K-877 CR Tablet B and K-877 CR Tablet E in people with Healthy, run by Kowa Research Institute, Inc. at 1 site in United States.
Trial summary
A study to compare the pharmacokinetics of 3 types of K-877 controlled release tablets with a current normal K-877 tablet in healthy adult subjects. 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-877 CR Tablet A, K-877 CR Tablet B and K-877 CR Tablet E
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2018to 20 Nov 2018
- 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 body mass index of 18 to 30 kg/m2, inclusive, at Screening.
- Subject meets all inclusion criteria outlined in the clinical study protocol.
Who cannot join
- Subject has clinically relevant abnormalities in the screening or check-in assessments.
- Subject has a supine blood pressure (as measured at Screening during the collection of vital signs) 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 60 mm Hg diastolic (males) or 50 mm Hg diastolic (females). If the initial blood pressure is out of range, blood pressure may be repeated after the subject has maintained a rested position in a quiet environment for at least 10 minutes.
- Subject has a supine pulse rate (as measured at Screening during the collection of vital signs) after resting for 5 minutes that is outside the range of 40 to 90 beats per minute. If the initial pulse rate is out of range, the pulse rate may be repeated after the subject has maintained a rested position in a quiet environment for at least 10 minutes.
- 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: Single-Dose, Randomized, Open-Label, 4-Period, 4-Sequence Crossover Study of Three Prototypes of K-877 CR Tablet and Two K-877 Tablets Administered to Healthy Adult Volunteers
A study to compare the pharmacokinetics of 3 types of K-877 controlled release tablets with a current normal K-877 tablet in healthy adult subjects.
- Conditions
- Healthy
- Being tested
- K-877 CR Tablet A, K-877 CR Tablet B, K-877 CR Tablet E, K-877 IR Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K-877 CR Tablet ADrug
K-877 Controlled Release Tablet A
K-877 CR Tablet BDrug
K-877 Controlled Release Tablet B
K-877 CR Tablet EDrug
K-877 Controlled Release Tablet E
K-877 IR TabletDrug
K-877 Immediate Release Tablet
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | K-877 CR Tablet A Receives: Drug: K-877 CR Tablet A; Drug: K-877 CR Tablet B; Drug: K-877 CR Tablet E; Drug: K-877 IR Tablet |
| Treatment B | Experimental | K-877 CR Tablet B Receives: Drug: K-877 CR Tablet A; Drug: K-877 CR Tablet B; Drug: K-877 CR Tablet E; Drug: K-877 IR Tablet |
| Treatment C | Experimental | K-877 CR Tablet E Receives: Drug: K-877 CR Tablet A; Drug: K-877 CR Tablet B; Drug: K-877 CR Tablet E; Drug: K-877 IR Tablet |
| Treatment D | Experimental | K-877 IR Tablet Receives: Drug: K-877 CR Tablet A; Drug: K-877 CR Tablet B; Drug: K-877 CR Tablet E; Drug: K-877 IR Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration Versus Time Curve (AUC)
Measured: Up to 24 hours after single administration
Maximum Measured Plasma Concentration (Cmax)
Measured: Up to 24 hours after single administration
Secondary outcomes (1)
Treatment emergent adverse events summarized by treatment
Measured: Up to 16 days after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start5 Oct 2018
- Primary completion20 Nov 2018
- Study completion20 Nov 2018
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT03702673
- Sponsor's protocol ID
- K-877-101CR
- Status last verified
- Dec 2018
- First submitted
- 8 Oct 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Dose, Randomized, Open-Label, 4-Period, 4-Sequence Crossover Study of Three Prototypes of K-877 CR Tablet and Two K-877 Tablets Administered to Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT03702673
- Acronym / sponsor ID
- K-877-101CR
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Kowa Research Institute, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Oct 2018 (actual)
- Primary completion
- 20 Nov 2018 (actual)
- Study completion
- 20 Nov 2018 (actual)
- First posted
- 11 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.
A study to compare the pharmacokinetics of 3 types of K-877 controlled release tablets with a current normal K-877 tablet in healthy adult subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: K-877 CR Tablet A, Drug: K-877 CR Tablet B, Drug: K-877 CR Tablet E, Drug: K-877 IR TabletK-877 CR Tablet A |
| Treatment B | Experimental | Drug: K-877 CR Tablet A, Drug: K-877 CR Tablet B, Drug: K-877 CR Tablet E, Drug: K-877 IR TabletK-877 CR Tablet B |
| Treatment C | Experimental | Drug: K-877 CR Tablet A, Drug: K-877 CR Tablet B, Drug: K-877 CR Tablet E, Drug: K-877 IR TabletK-877 CR Tablet E |
| Treatment D | Experimental | Drug: K-877 CR Tablet A, Drug: K-877 CR Tablet B, Drug: K-877 CR Tablet E, Drug: K-877 IR TabletK-877 IR Tablet |
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 body mass index of 18 to 30 kg/m2, inclusive, at Screening.
- Subject meets all inclusion criteria outlined in the clinical study protocol.
Key exclusion criteria (4 listed)
- Subject has clinically relevant abnormalities in the screening or check-in assessments.
- Subject has a supine blood pressure (as measured at Screening during the collection of vital signs) 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 60 mm Hg diastolic (males) or 50 mm Hg diastolic (females). If the initial blood pressure is out of range, blood pressure may be repeated after the subject has maintained a rested position in a quiet environment for at least 10 minutes.
- Subject has a supine pulse rate (as measured at Screening during the collection of vital signs) after resting for 5 minutes that is outside the range of 40 to 90 beats per minute. If the initial pulse rate is out of range, the pulse rate may be repeated after the subject has maintained a rested position in a quiet environment for at least 10 minutes.
- 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-877 CR Tablet AK-877 Controlled Release Tablet A | Drug | Treatment A, Treatment B, Treatment C, Treatment D |
| K-877 CR Tablet BK-877 Controlled Release Tablet B | Drug | Treatment A, Treatment B, Treatment C, Treatment D |
| K-877 CR Tablet EK-877 Controlled Release Tablet E | Drug | Treatment A, Treatment B, Treatment C, Treatment D |
| K-877 IR TabletK-877 Immediate Release Tablet | Drug | Treatment A, Treatment B, Treatment C, Treatment D |
Primary outcome
Area Under the Plasma Concentration Versus Time Curve (AUC)
Time frame: Up to 24 hours after single administration
Maximum Measured Plasma Concentration (Cmax)
Time frame: Up to 24 hours after single administration
1 secondary outcome
Treatment emergent adverse events summarized by treatment
Time frame: Up to 16 days after administration
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 19 Dec 2018.
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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-877 CR Tablet A, K-877 CR Tablet B and K-877 CR Tablet E 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 19 Dec 2018. 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 Versus Time Curve (AUC) (time frame: Up to 24 hours after single administration). 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 19 Dec 2018.