HealthyPhase 1NCT02275988
Drug-Drug Interaction Study in Healthy Adult Volunteers
A Phase 1 study testing K-877 and Clarithromycin in people with Healthy, run by Kowa Research Institute, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to assess the effects of clarithromycin on the pharmacokinetics of K-877 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 and Clarithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Aug 2014
- 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 is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at Screening.
- Subject has a body mass index of 18 to 30 kg/m2, inclusive, at Screening.
- Subject has hematology, serum chemistry, and urinalysis test results within the reference ranges or is showing no clinically relevant deviations, as judged by the investigator at Screening.
Who cannot join
- Subject has clinically relevant abnormalities in the screening or check in assessments.
- Subject has a blood pressure (as measured at Screening during the collection of vital signs) after resting supine for at least 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 (for males) and 50 mm Hg diastolic (for females).
- Subject has a supine pulse rate (as measured at Screening during collection of vital signs) after resting for 5 minutes that is outside the range of 40 to 90 beats per minute.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the effects of clarithromycin on the pharmacokinetics of K-877 in healthy adult subjects.
- Conditions
- Healthy
- Being tested
- K-877, Clarithromycin
- Keywords
- Adult Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K-877Drug
ClarithromycinDrug
| Study group | Role | What they receive |
|---|---|---|
| K-877 | Experimental | K-877 Receives: Drug: K-877 |
| K-877 with Clarithromycin | Experimental | K-877 with Clarithromycin Receives: Drug: K-877; Drug: Clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration (Cmax)
Measured: 72 hours
Secondary outcomes (1)
Area under concentration curve (AUC)
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2014
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
- Allocation
- Non-randomised
- 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
- Investigators
- Stuart Campbell, Study director, Kowa Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275988
- Sponsor's protocol ID
- K-877-104
- Status last verified
- Oct 2014
- First submitted
- 23 Oct 2014
- Last updated
- 27 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug-Drug Interaction Study in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT02275988
- Acronym / sponsor ID
- K-877-104
- Conditions
- Healthy
- Keywords
- Adult Volunteers
- 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
- Jun 2014
- Primary completion
- Aug 2014 (actual)
- First posted
- 27 Oct 2014 (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.
The purpose of this study is to assess the effects of clarithromycin on the pharmacokinetics of K-877 in healthy adult subjects.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| K-877 | Experimental | Drug: K-877K-877 |
| K-877 with Clarithromycin | Experimental | Drug: K-877, Drug: ClarithromycinK-877 with Clarithromycin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at Screening.
- Subject has a body mass index of 18 to 30 kg/m2, inclusive, at Screening.
- Subject has hematology, serum chemistry, and urinalysis test results within the reference ranges or is showing no clinically relevant deviations, as judged by the investigator at Screening.
Key exclusion criteria (3 listed)
- Subject has clinically relevant abnormalities in the screening or check in assessments.
- Subject has a blood pressure (as measured at Screening during the collection of vital signs) after resting supine for at least 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 (for males) and 50 mm Hg diastolic (for females).
- Subject has a supine pulse rate (as measured at Screening during collection of vital signs) after resting for 5 minutes that is outside the range of 40 to 90 beats per minute.
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 | Drug | K-877, K-877 with Clarithromycin |
| Clarithromycin | Drug | K-877 with Clarithromycin |
Primary outcome
Maximum concentration (Cmax)
Time frame: 72 hours
1 secondary outcome
Area under concentration curve (AUC)
Time frame: 72 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 27 Oct 2014.
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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.
Stuart Campbell study director
Kowa Research Institute, Inc.
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 Clarithromycin 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 3 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 27 Oct 2014. 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 concentration (Cmax) (time frame: 72 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 27 Oct 2014.