HealthyPhase 1NCT05722262
Study to Demonstrate the Bioequivalence of Single Oral Administration of K-001 Relative to Single Oral Coadministration of Separate Tablets of K-877-ER and CSG452
A Phase 1 study testing K-001, K-877-ER and CSG452 in people with Healthy, run by Kowa Research Institute, Inc. at 1 site in United States.
Trial summary
The goal of this clinical trial is to demonstrate the bioequivalence of single oral administration of K-001 relative to single oral co-administration of separate tablets of K-877-ER and CSG452 in healthy adult volunteers, and to characterize the food effect on the Pharmacokinetics(PK) of K-001. 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-001, K-877-ER and CSG452
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2023to 5 Apr 2023
- 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
- Participant provides written informed consent before any study-specific evaluation is performed.
- Participant is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at Screening.
- Participant has a body mass index of 18 to 30 kg/m2, inclusive, at Screening.
- Participant meet all other inclusion criteria outlined in the clinical study protocol.
Who cannot join
- Participant has clinically significant abnormalities at Screening or at Check-in assessments, in the opinion of the investigator.
- Participant is pregnant or breastfeeding or intends to become pregnant within 30 days after the last dose of study drug.
- Participant meets any other exclusion criteria outlined in the clinical study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Six-Sequence, Three-Period Crossover Study to Demonstrate the Bioequivalence of Single Oral Administration of K-001 Relative to Single Oral Coadministration of Separate Tablets of K-877-ER Plus CSG452 in Healthy Adult Volunteers, and to Characterize the Food Effect on the Pharmacokinetics of K-001
The goal of this clinical trial is to demonstrate the bioequivalence of single oral administration of K-001 relative to single oral co-administration of separate tablets of K-877-ER and CSG452 in healthy adult volunteers, and to characterize the food effect on the Pharmacokinetics(PK) of K-001.
- Conditions
- Healthy
- Being tested
- K-001, K-877-ER, CSG452
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K-001Drug
K-877-ER and CSG452 combination tablet
K-877-ERDrug
K-877-ER tablet
CSG452Drug
CSG452 tablet
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Three period alternative intervention and fed/fasted sequence Receives: Drug: K-001; Drug: K-877-ER; Drug: CSG452 |
| Sequence B | Experimental | Three period alternative intervention and fed/fasted sequence Receives: Drug: K-001; Drug: K-877-ER; Drug: CSG452 |
| Sequence C | Experimental | Three period alternative intervention and fed/fasted sequence Receives: Drug: K-001; Drug: K-877-ER; Drug: CSG452 |
| Sequence D | Experimental | Three period alternative intervention and fed/fasted sequence Receives: Drug: K-001; Drug: K-877-ER; Drug: CSG452 |
| Sequence E | Experimental | Three period alternative intervention and fed/fasted sequence Receives: Drug: K-001; Drug: K-877-ER; Drug: CSG452 |
| Sequence F | Experimental | Three period alternative intervention and fed/fasted sequence Receives: Drug: K-001; Drug: K-877-ER; Drug: CSG452 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of K-877 and CSG452
Maximum observed plasma concentration (Cmax) of K-877 and CSG452
Measured: 1 hour before dosing and at multiple time points (up to 48 hours) post dose
AUC0-t of K-877 and CSG452
Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration (AUC0-t)
Measured: 1 hour before dosing and at multiple time points (up to 48 hours) post dose
AUC0-inf of K-877-and CSG452
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity (AUC0-inf).
Measured: 1 hour before dosing and at multiple time points (up to 48 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 posted10 Feb 2023
- Study start24 Feb 2023
- Primary completion1 Apr 2023
- Study completion5 Apr 2023
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Randomized, open-label, six-sequence, three-period, crossover study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 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
- NCT05722262
- Sponsor's protocol ID
- K-001-1.02
- Status last verified
- Jun 2023
- First submitted
- 1 Feb 2023
- Last updated
- 2 Jun 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Six-Sequence, Three-Period Crossover Study to Demonstrate the Bioequivalence of Single Oral Administration of K-001 Relative to Single Oral Coadministration of Separate Tablets of K-877-ER Plus CSG452 in Healthy Adult Volunteers, and to Characterize the Food Effect on the Pharmacokinetics of K-001
- ClinicalTrials.gov ID
- NCT05722262
- Acronym / sponsor ID
- K-001-1.02
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kowa Research Institute, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 5 Apr 2023 (actual)
- First posted
- 10 Feb 2023 (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.
The goal of this clinical trial is to demonstrate the bioequivalence of single oral administration of K-001 relative to single oral co-administration of separate tablets of K-877-ER and CSG452 in healthy adult volunteers, and to characterize the food effect on the Pharmacokinetics(PK) of K-001.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Randomized, open-label, six-sequence, three-period, crossover study
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: K-001, Drug: K-877-ER, Drug: CSG452Three period alternative intervention and fed/fasted sequence |
| Sequence B | Experimental | Drug: K-001, Drug: K-877-ER, Drug: CSG452Three period alternative intervention and fed/fasted sequence |
| Sequence C | Experimental | Drug: K-001, Drug: K-877-ER, Drug: CSG452Three period alternative intervention and fed/fasted sequence |
| Sequence D | Experimental | Drug: K-001, Drug: K-877-ER, Drug: CSG452Three period alternative intervention and fed/fasted sequence |
| Sequence E | Experimental | Drug: K-001, Drug: K-877-ER, Drug: CSG452Three period alternative intervention and fed/fasted sequence |
| Sequence F | Experimental | Drug: K-001, Drug: K-877-ER, Drug: CSG452Three period alternative intervention and fed/fasted sequence |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participant provides written informed consent before any study-specific evaluation is performed.
- Participant is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at Screening.
- Participant has a body mass index of 18 to 30 kg/m2, inclusive, at Screening.
- Participant meet all other inclusion criteria outlined in the clinical study protocol.
Key exclusion criteria (3 listed)
- Participant has clinically significant abnormalities at Screening or at Check-in assessments, in the opinion of the investigator.
- Participant is pregnant or breastfeeding or intends to become pregnant within 30 days after the last dose of study drug.
- Participant meets 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-001K-877-ER and CSG452 combination tablet | Drug | Sequence A, Sequence B, Sequence C, Sequence D, Sequence E, Sequence F |
| K-877-ERK-877-ER tablet | Drug | Sequence A, Sequence B, Sequence C, Sequence D, Sequence E, Sequence F |
| CSG452CSG452 tablet | Drug | Sequence A, Sequence B, Sequence C, Sequence D, Sequence E, Sequence F |
Primary outcome
Cmax of K-877 and CSG452
Time frame: 1 hour before dosing and at multiple time points (up to 48 hours) post dose
Maximum observed plasma concentration (Cmax) of K-877 and CSG452
AUC0-t of K-877 and CSG452
Time frame: 1 hour before dosing and at multiple time points (up to 48 hours) post dose
Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration (AUC0-t)
AUC0-inf of K-877-and CSG452
Time frame: 1 hour before dosing and at multiple time points (up to 48 hours) post dose
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity (AUC0-inf).
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 2 Jun 2023.
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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-001, K-877-ER 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 2 Jun 2023. 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?
Cmax of K-877 and CSG452 (time frame: 1 hour before dosing and at multiple time points (up to 48 hours) post dose). The study lists 3 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 2 Jun 2023.