Healty VolunteersPhase 1NCT06821698
To Determine the Effect of KP-001 on Rosuvastatin, Caffeine PK and the Effect of Fluvoxamine on KP-001 PK in Volunteers
A Phase 1 study testing KP-001, Rosuvastatin calcium10mg and Caffeine citrate in people with Healty Volunteers, run by Kaken Pharmaceutical at 1 site in United States.
Trial summary
Part 1 will evaluate the effects of KP-001 as an inhibitor of BCRP on the PK of rosuvastatin. In the Treatment Period 1, a single dose of rosuvastatin will be administered. In the Treatment Period 2, KP-001 will be administered once daily for 7 days and a single dose of rosuvastatin will be administered. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healty Volunteers
- What is being tested?
- KP-001, Rosuvastatin calcium10mg and Caffeine citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2025to 20 May 2025
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A participant who voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to performing any of the Screening Visit procedures.
- A male or female participant who is between 18 to 55 years of age, inclusive, at the Screening Visit.
- (Part 1 only) A participant who is non-Asian.
- A female participant who is non-childbearing potential defined in Section 10.4 and not pregnant or breastfeeding.
- A male participant who is sexually active with female partner(s) of childbearing potential must agree to use both a condom and spermicide from the first dose until 91 days after the last dose of KP-001.
- A male participant who agrees not to donate sperm from the first dose until 91 days after the last dose of KP-001.
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- A continuous nonsmoker who has not used nicotine-containing products for at least 3 months prior to Day -1 of Treatment Period 1 and throughout the study, based on participant self-reporting and the result of cotinine test at screening and/or Day -1 of each Treatment Period.
- A participant who is medically healthy with no clinically significant abnormal screening results (eg, medical history, physical examination, laboratory profiles, vital signs, or ECGs), in the opinion of the Investigator or designee. If screening and/or admission results are abnormal, they may be repeated once at screening and/or once at admission to confirm the participant's eligibility.
- A participant who has body weight ≥ 50.0 kg and body mass index within the range 18.0 to 30.0 kg/m2, inclusive, at the Screening Visit.
Who cannot join
- A participant who is legally, mentally or physically incapacitated or, in the opinion of the Investigator, has significant mental or emotional problems, including psychiatric illness (eg, depression and/or anxiety) at the time of the Screening Visit, or that could reasonably be expected to develop during the conduct of the study.
- A participant with significant history or clinical manifestation of any metabolic, allergic, dermatologic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder as determined by the Investigator or designee.
- A participant with a history of any illness that, in the opinion of the Investigator or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
- (For Part 3 only) A participant who meets any of the following criteria based on the C-SSRS assessment at screening:
- Presence of suicidal ideation within the 6 months prior to screening (an answer of "yes" on Questions 1 or 2 of the C-SSRS Baseline/Screening version)
- Any lifetime history of suicidal ideation (an answer of "yes" on Questions 4 or 5 of the C-SSRS Baseline/Screening version).
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- Any lifetime history of suicidal behavior as detected by the C-SSRS Baseline/Screening version.
- A participant who used any prescription or non-prescription medications (including vitamins, recreational drugs, and dietary or herbal supplements) within 14 days or 5 half-lives (whichever is longer) prior to Day -1 of Treatment Period 1 and until completion of the Follow-up Call unless, in the opinion of the Investigator, may be treatment for an AE or will not interfere with the interpretation of safety or the PK assessments.
- A participant who underwent blood donation or transfusion within 56 days prior to Day -1 of Treatment Period 1 and throughout the study.
- A participant with a history or presence of hypersensitivity or idiosyncratic reaction to any components of the KP-001 formulation or any components of formulation used as study intervention during the study.
- A participant with a history of drug or alcohol abuse (regular alcohol consumption exceeding 14 drinks/week [1 drink=5 ounces of wine, 12 ounces of beer, or 1.5 ounces of hard liquor]) within one year before the Screening Visit.
- A participant who has enrolled in any clinical study of KP-001.
- A participant with a complication of drug allergies or a history of drug allergies.
- A participant who used any investigational drug in the last 30 days or 5 half-lives (if known), whichever is longer, prior to Day -1 of Treatment Period 1.
- A participant who had any major illness within 30 days before the Screening Visit.
- A participant who had any major surgical procedure within 30 days prior to Day -1 of Treatment Period 1 or any planned surgery during the study period.
- A participant who had any laboratory abnormality that, in the judgment of the Investigator, would put the participant at unacceptable risk for participation in the study or may interfere with the assessments included in the study.
- A participant with abnormal findings on the screening ECG deemed clinically significant by the Investigator or qualified designee.
- A participant who is an employee of the Sponsor or any CRO involved in the study, the Investigator, or an immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of an employee involved in the study.
- (Part 2) A participant who has consumed alcohol- or caffeine-containing foods and beverages (eg, coffee, tea, cola, soda, cocoa, chocolate, and energy drink) within 72 hours prior to Day -1 of Treatment Period 1 and does not agree to refrain from consuming during the entire study. (Parts 1 and 3) A participant who has consumed alcohol- or caffeine-containing foods and beverages (eg, coffee, tea, cola, soda, cocoa, chocolate, and energy drink) within 72 hours prior to Day -1 of Treatment Period 1 and does not agree to refrain from consuming during the entire study, unless deemed acceptable by the Investigator.
- A participant with positive urine drug or urine alcohol and positive cotinine test results at screening or Day -1 of Treatment Period 1.
- A participant who has consumed grapefruit-containing foods and beverages within 7 days prior to Day -1 of Treatment Period 1 and does not agree to refrain from consuming during the entire study.
- A participant who has consumed St. John's wort-containing foods and beverages within 14 days prior to Day -1 of Treatment Period 1 and does not agree to refrain from consuming during the entire study.
- A participant who is unable or unwilling to undergo multiple venipunctures.
- A participant with a history or presence of liver disease or cholecystectomy within one year prior to screening.
- A participant with an HbA1c >5.7% at screening.
- A participant with positive results at screening for human immunodeficiency virus, hepatitis B core antibody, hepatitis B surface antigen or hepatitis C virus.
- A participant with a disorder or any condition that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
- A participant with an eGFR calculated using the CKD-EPI formula <80 mL/min at screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
Parexel International Early Phase Clinical Unit
Glendale, California, 91206
About this study
Official title: An Open-label Study to Determine the Effect of Oral Doses of KP-001 on Rosuvastatin and Caffeine PK After a Single Oral Administration and to Determine the Effect of Fluvoxamine on KP-001 PK After a Single Oral Administration in Volunteers
Part 1 will evaluate the effects of KP-001 as an inhibitor of BCRP on the PK of rosuvastatin. In the Treatment Period 1, a single dose of rosuvastatin will be administered. In the Treatment Period 2, KP-001 will be administered once daily for 7 days and a single dose of rosuvastatin will be administered. Blood PK assessments of rosuvastatin will be performed until 48 hours postdose in each Treatment Period. Part 2 will evaluate the effects of KP-001 as an inducer and inhibitor of CYP1A2 on the PK of caffeine. A single dose of caffeine will be administered in the Treatment Period 1. KP-001 will be administered once daily for 10 days and a single dose of caffeine will be administered in the Treatment Period 2. Blood PK assessments of caffeine will be performed until 24 hours postdose in each Treatment Period. Part 3 will evaluate the effects of fluvoxamine as an inhibitor of CYP1A2 on the PK of KP-001. A single dose of KP-001 will be administered in the Treatment Period 1. Fluvoxamine will be administered as a single dose on the first day and then twice daily for 5 days and a single dose of KP-001 will be administered in the Treatment Period 2. Blood PK assessments of KP-001 will be performed until 48 hours postdose in each Treatment Period.
- Conditions
- Healty Volunteers
- Being tested
- KP-001, Rosuvastatin calcium10mg, Caffeine citrate, Fluvoxamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KP-001Drug
KP-001 100 mg dry syrup
Rosuvastatin calcium10mgDrug
A oral dose of 10 mg tablet
Caffeine citrateDrug
100 mg oral solution
FluvoxamineDrug
50 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| KP-001/Rosuvastatin calcium | Experimental | Not described Receives: Drug: KP-001; Drug: Rosuvastatin calcium10mg |
| KP-001/Caffeine citrate | Experimental | Not described Receives: Drug: KP-001; Drug: Caffeine citrate |
| KP-001/Fluvoxamine | Experimental | Not described Receives: Drug: KP-001; Drug: Fluvoxamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters of rosuvastatin in plasma: AUCinf
Measured: 48hour
PK parameters of rosuvastatin in plasma: Cmax
Measured: 48hour
PK parameters of caffeine in plasma: AUCinf
Measured: 24hour
PK parameters of caffeine in plasma: Cmax
Measured: 24hour
PK parameters of KP-001 in plasma: AUCinf
Measured: 48hour
PK parameters of KP-001 in plasma: Cmax
Measured: 48hour
Secondary outcomes (14)
PK parameters of rosuvastatin in plasma: AUClast
Measured: 48hour
PK parameters of rosuvastatin in plasma: Tmax
Measured: 48hour
PK parameters of rosuvastatin in plasma: t1/2
Measured: 48hour
PK parameters of rosuvastatin in plasma: CLtot/F
Measured: 48hour
PK parameters of rosuvastatin in plasma: Vz/F
Measured: 48hour
PK parameters of caffeine in plasma: AUClast
Measured: 24hour
PK parameters of caffeine in plasma: t1/2
Measured: 24hour
PK parameters of caffeine in plasma: Tmax
Measured: 24hour
PK parameters of caffeine in plasma: CLtot/F
Measured: 24hour
PK parameters of caffeine in plasma: Vz/F
Measured: 24hour
PK parameters of KP-001 in plasma: AUClast
Measured: 48hour
PK parameters of KP-001 in plasma: Tmax
Measured: 48hour
PK parameters of KP-001 in plasma: t1/2
Measured: 48hour
PK parameters of KP-001 in plasma: Vz/F
Measured: 48hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start13 Feb 2025
- Primary completion20 May 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healty VolunteersStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaken Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821698
- Sponsor's protocol ID
- KP-001-106
- Status last verified
- Sep 2025
- First submitted
- 6 Feb 2025
- Last updated
- 12 Sep 2025
- 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 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Determine the Effect of Oral Doses of KP-001 on Rosuvastatin and Caffeine PK After a Single Oral Administration and to Determine the Effect of Fluvoxamine on KP-001 PK After a Single Oral Administration in Volunteers
- ClinicalTrials.gov ID
- NCT06821698
- Acronym / sponsor ID
- KP-001-106
- Conditions
- Healty Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Kaken PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 12 Feb 2025 (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.
Part 1 will evaluate the effects of KP-001 as an inhibitor of BCRP on the PK of rosuvastatin. In the Treatment Period 1, a single dose of rosuvastatin will be administered. In the Treatment Period 2, KP-001 will be administered once daily for 7 days and a single dose of rosuvastatin will be administered. Blood PK assessments of rosuvastatin will be performed until 48 hours postdose in each Treatment Period. Part 2 will evaluate the effects of KP-001 as an inducer and inhibitor of CYP1A2 on the PK of caffeine. A single dose of caffeine will be administered in the Treatment Period 1. KP-001 will be administered once daily for 10 days and a single dose of caffeine will be administered in the Treatment Period 2. Blood PK assessments of caffeine will be performed until 24 hours postdose in each Treatment Period. Part 3 will evaluate the effects of fluvoxamine as an inhibitor of CYP1A2 on the PK of KP-001. A single dose of KP-001 will be administered in the Treatment Period 1. Fluvoxamine will be administered as a single dose on the first day and then twice daily for 5 days and a single dose of KP-001 will be administered in the Treatment Period 2. Blood PK assessments of KP-001 will be performed until 48 hours postdose in each Treatment Period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| KP-001/Rosuvastatin calcium | Experimental | Drug: KP-001, Drug: Rosuvastatin calcium10mg |
| KP-001/Caffeine citrate | Experimental | Drug: KP-001, Drug: Caffeine citrate |
| KP-001/Fluvoxamine | Experimental | Drug: KP-001, Drug: Fluvoxamine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- A participant who voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to performing any of the Screening Visit procedures.
- A male or female participant who is between 18 to 55 years of age, inclusive, at the Screening Visit.
- (Part 1 only) A participant who is non-Asian.
- A female participant who is non-childbearing potential defined in Section 10.4 and not pregnant or breastfeeding.
- A male participant who is sexually active with female partner(s) of childbearing potential must agree to use both a condom and spermicide from the first dose until 91 days after the last dose of KP-001.
Key exclusion criteria (29 listed)
- A participant who is legally, mentally or physically incapacitated or, in the opinion of the Investigator, has significant mental or emotional problems, including psychiatric illness (eg, depression and/or anxiety) at the time of the Screening Visit, or that could reasonably be expected to develop during the conduct of the study.
- A participant with significant history or clinical manifestation of any metabolic, allergic, dermatologic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder as determined by the Investigator or designee.
- A participant with a history of any illness that, in the opinion of the Investigator or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
- (For Part 3 only) A participant who meets any of the following criteria based on the C-SSRS assessment at screening:
- A participant who used any prescription or non-prescription medications (including vitamins, recreational drugs, and dietary or herbal supplements) within 14 days or 5 half-lives (whichever is longer) prior to Day -1 of Treatment Period 1 and until completion of the Follow-up Call unless, in the opinion of the Investigator, may be treatment for an AE or will not interfere with the interpretation of safety or the PK assessments.
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 |
|---|---|---|
| KP-001KP-001 100 mg dry syrup | Drug | KP-001/Caffeine citrate, KP-001/Fluvoxamine, KP-001/Rosuvastatin calcium |
| Rosuvastatin calcium10mgA oral dose of 10 mg tablet | Drug | KP-001/Rosuvastatin calcium |
| Caffeine citrate100 mg oral solution | Drug | KP-001/Caffeine citrate |
| Fluvoxamine50 mg tablet | Drug | KP-001/Fluvoxamine |
Primary outcome
PK parameters of rosuvastatin in plasma: AUCinf
Time frame: 48hour
PK parameters of rosuvastatin in plasma: Cmax
Time frame: 48hour
PK parameters of caffeine in plasma: AUCinf
Time frame: 24hour
PK parameters of caffeine in plasma: Cmax
Time frame: 24hour
PK parameters of KP-001 in plasma: AUCinf
Time frame: 48hour
PK parameters of KP-001 in plasma: Cmax
Time frame: 48hour
14 secondary outcomes
PK parameters of rosuvastatin in plasma: AUClast
Time frame: 48hour
PK parameters of rosuvastatin in plasma: Tmax
Time frame: 48hour
PK parameters of rosuvastatin in plasma: t1/2
Time frame: 48hour
PK parameters of rosuvastatin in plasma: CLtot/F
Time frame: 48hour
PK parameters of rosuvastatin in plasma: Vz/F
Time frame: 48hour
PK parameters of caffeine in plasma: AUClast
Time frame: 24hour
PK parameters of caffeine in plasma: t1/2
Time frame: 24hour
PK parameters of caffeine in plasma: Tmax
Time frame: 24hour
PK parameters of caffeine in plasma: CLtot/F
Time frame: 24hour
PK parameters of caffeine in plasma: Vz/F
Time frame: 24hour
PK parameters of KP-001 in plasma: AUClast
Time frame: 48hour
PK parameters of KP-001 in plasma: Tmax
Time frame: 48hour
PK parameters of KP-001 in plasma: t1/2
Time frame: 48hour
PK parameters of KP-001 in plasma: Vz/F
Time frame: 48hour
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 12 Sep 2025.
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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 KP-001, Rosuvastatin calcium10mg and Caffeine citrate in people with Healty Volunteers, run by Kaken Pharmaceutical 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 9 inclusion and 29 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 12 Sep 2025. 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?
PK parameters of rosuvastatin in plasma: AUCinf (time frame: 48hour). The study lists 6 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 12 Sep 2025.