HealthyPhase 1NCT04237597
Pharmacokinetic Drug-Drug Interaction Study Between K-877 and CSG452 in Healthy Adult Volunteers
A Phase 1 study testing K-877 and CSG452 in people with Healthy, run by Kowa Research Institute, Inc. at 1 site in United States.
Trial summary
A study to compare the pharmacokinetic(s) of K-877 and CSG452 when each drug is administered alone and when both are administered together. 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 and CSG452
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2019to 4 Mar 2020
- 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 volunteer between the ages of 18 and 45 years, inclusive, at Screening.
- Subject has a BMI of 18 to 30 kg/m2, inclusive, at Screening.
- Subject meets all other inclusion criteria outlined in the clinical study protocol
Who cannot join
- Subject has clinically relevant abnormalities at Screening or at Check-in assessments.
- Subject is pregnant or breastfeeding or intends to become pregnant within 30 days after the last dose of study drug.
- Subject does not meet any other exclusion criteria outlined in the clinical study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
A study to compare the pharmacokinetic(s) of K-877 and CSG452 when each drug is administered alone and when both are administered together.
- Conditions
- Healthy
- Being tested
- K-877, CSG452
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K-877Drug
K-877 tablets
CSG452Drug
CSG452 tablets
| Study group | Role | What they receive |
|---|---|---|
| K-877 & CSG452 | Experimental | K-877 Single dose on Day 1 and Day 15 CSG452 Repeat dose on Day 2 Through Day 15 Receives: Drug: K-877; Drug: CSG452 |
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: 0 to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start17 Dec 2019
- Primary completion31 Jan 2020
- Study completion4 Mar 2020
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT04237597
- Sponsor's protocol ID
- K-001-001
- Status last verified
- Sep 2020
- First submitted
- 16 Jan 2020
- Last updated
- 22 Sep 2020
- 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 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Drug-Drug Interaction Study Between K-877 and CSG452 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT04237597
- Acronym / sponsor ID
- K-001-001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kowa Research Institute, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Dec 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 4 Mar 2020 (actual)
- First posted
- 23 Jan 2020 (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 pharmacokinetic(s) of K-877 and CSG452 when each drug is administered alone and when both are administered together.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| K-877 & CSG452 | Experimental | Drug: K-877, Drug: CSG452K-877 Single dose on Day 1 and Day 15 CSG452 Repeat dose on Day 2 Through Day 15 |
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 volunteer between the ages of 18 and 45 years, inclusive, at Screening.
- Subject has a BMI of 18 to 30 kg/m2, inclusive, at Screening.
- Subject meets all other inclusion criteria outlined in the clinical study protocol
Key exclusion criteria (3 listed)
- Subject has clinically relevant abnormalities at Screening or at Check-in assessments.
- Subject is pregnant or breastfeeding or intends to become pregnant within 30 days after the last dose of study drug.
- Subject does not meet any other 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-877K-877 tablets | Drug | K-877 & CSG452 |
| CSG452CSG452 tablets | Drug | K-877 & CSG452 |
Primary outcome
Area under the plasma concentration versus time curve (AUC)
Time frame: 0 to 24 hours
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 22 Sep 2020.
- 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-877 and CSG452 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 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 22 Sep 2020. 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: 0 to 24 hours). 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 22 Sep 2020.