KP-001 for Drug Interaction Study

Overseen By Motoki Akamatsu

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Kaken Pharmaceutical

Must not be taking: Recreational drugs, St. John's wort

Disqualifiers: Psychiatric disorder, Drug abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study how the experimental drug KP-001 interacts with other substances, such as the cholesterol medication rosuvastatin and caffeine. Researchers seek to understand how KP-001 affects the processing of these substances in the body. The trial consists of multiple parts, each testing KP-001 with a different substance. Individuals who have not smoked and do not have significant health issues may be suitable candidates for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I need to stop taking my current medications to join the trial?

Yes, participants must stop taking any prescription or non-prescription medications, including vitamins and supplements, at least 14 days before the trial starts and until the follow-up call, unless the investigator approves otherwise.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that fluvoxamine interacts with over 700 other medications, necessitating caution when combined with other drugs. While some interactions are serious, many can be managed with a doctor's guidance.

Rosuvastatin is generally well-tolerated, with about 260 known interactions. However, studies have indicated that it does not significantly interact with cytochrome P450, a major enzyme group in the body, making it somewhat easier to manage.

Caffeine is generally safe in moderate amounts, but high doses can increase the risk of high blood pressure and affect the efficacy of some seizure medications.

KP-001 remains in early-stage trials, so clear data on its safety is not yet available. These trials focus on assessing safety, with close monitoring of any notable side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about KP-001 because it offers a fresh approach to managing drug interactions, which can be challenging with existing medications. Unlike standard treatments that often focus on a single drug, KP-001 is being explored in combination with various compounds like Fluvoxamine, Rosuvastatin calcium, and Caffeine citrate, potentially broadening its applicability and effectiveness. This study could illuminate how KP-001 interacts with these different drugs, paving the way for more personalized and efficient treatment plans. By understanding these interactions better, there's hope for minimizing side effects and enhancing the therapeutic benefits of the combined medications.

What evidence suggests that this trial's treatments could be effective?

This trial will examine the interactions of KP-001 with different medications. One arm of the trial combines KP-001 with Fluvoxamine. Research has shown that Fluvoxamine effectively treats symptoms of OCD (obsessive-compulsive disorder), with success rates between 38% and 52%. However, Fluvoxamine can alter the effects of other medications, especially those requiring precise dosing.

Another arm of the trial combines KP-001 with Rosuvastatin. Rosuvastatin is well-known for lowering LDL (bad cholesterol) levels, reducing the risk of heart problems. It has few side effects, with serious muscle injury occurring in less than 0.1% of cases.

The third arm of the trial combines KP-001 with Caffeine. Caffeine has been widely studied for its effects on the body, including its influence on brain activity and the immune system. It might even enhance the body's immune response against tumors. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

Healthy volunteers aged 18-55, non-smokers for at least 3 months, with a BMI of 18.0 to 30.0 kg/m2 can join this trial. Women must not be able to bear children or be pregnant/breastfeeding; men must use contraception. Participants should have no significant health issues.

Inclusion Criteria

Medically healthy participant with no clinically significant abnormal screening results, in the opinion of the Investigator or designee

I am not pregnant, breastfeeding, and cannot become pregnant.

Participant who voluntarily agrees to participate in the study and signs an IRB-approved informed consent prior to performing any Screening Visit procedures

Exclusion Criteria

Participant with significant history or clinical manifestation of various disorders as determined by the Investigator or designee

I have no other illnesses that could affect the study or increase my risk.

I am not legally, mentally, or physically incapacitated and do not have significant mental or emotional problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1 - Rosuvastatin

A single dose of rosuvastatin is administered and blood PK assessments are performed until 48 hours postdose

1 week

Treatment Period 2 - KP-001 and Rosuvastatin

KP-001 is administered once daily for 7 days with a single dose of rosuvastatin, followed by blood PK assessments until 48 hours postdose

2 weeks

Treatment Period 1 - Caffeine

A single dose of caffeine is administered and blood PK assessments are performed until 24 hours postdose

1 week

Treatment Period 2 - KP-001 and Caffeine

KP-001 is administered once daily for 10 days with a single dose of caffeine, followed by blood PK assessments until 24 hours postdose

2 weeks

Treatment Period 1 - KP-001

A single dose of KP-001 is administered and blood PK assessments are performed until 48 hours postdose

1 week

Treatment Period 2 - Fluvoxamine and KP-001

Fluvoxamine is administered as a single dose on the first day and then twice daily for 5 days with a single dose of KP-001, followed by blood PK assessments until 48 hours postdose

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fluvoxamine
• KP-001

Trial Overview The study tests KP-001's effects on the body's handling of rosuvastatin and caffeine, and fluvoxamine's effect on KP-001. It involves taking these drugs separately or together over different periods with blood tests to measure drug levels.

How Is the Trial Designed?

Group I: KP-001/Rosuvastatin calcium Experimental Treatment 2 Interventions

Group II: KP-001/Fluvoxamine Experimental Treatment 2 Interventions

Group III: KP-001/Caffeine citrate Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Kaken Pharmaceutical

Lead Sponsor

Trials

9

Recruited

910+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06963411

NCT06963411 | Phase 1 Crossover Study Evaluating the ... The main questions it aims to answer are: To evaluate any carryover effect with a 7-day washout of different dose regimens of KP001 in healthy adult volunteers.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8914174/

Pharmacokinetics of Caffeine - PubMed Central - NIH Here we report the first integrative and systematic analysis of data on caffeine pharmacokinetics from 141 publications and provide a comprehensive high- ...

3. nature.com nature.com/articles/s41467-025-60958-0

Caffeine enhances antitumor T-cell activity by suppressing ... Caffeine significantly reduces tumor growth, extends survival, and enhances CD8 + T cell activity in CRC by suppressing kynurenine pathway.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0753332224010321

Recording of hippocampal activity on the effect ... The present study evaluated the electrocorticographic changes observed in the hippocampus of Wistar rats subjected to acute doses of caffeine.

5. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2021.752826/full

Pharmacokinetics of Caffeine: A Systematic Analysis ... Here we report the first integrative and systematic analysis of data on caffeine pharmacokinetics from 141 publications and provide a comprehensive high- ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06821698

To Determine the Effect of KP-001 on Rosuvastatin ... 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 ...

7. healthy.kaiserpermanente.org healthy.kaiserpermanente.org/health-wellness/drug-encyclopedia/drug.caffeine-200-mg-tablet.154160

caffeine 200 mg tablet Avoid drinking large amounts of beverages containing caffeine (coffee, tea, colas) or eating large amounts of chocolate while taking this medication. If you ...

8. healthy.kaiserpermanente.org healthy.kaiserpermanente.org/health-wellness/drug-encyclopedia/drug.ergotamine-1-mg-caffeine-100-mg-tablet.180527

ergotamine 1 mg-caffeine 100 mg tablet This medication has rarely caused a serious lack of blood flow to the arms/hands, or to the feet, or to the brain, which could cause a stroke.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11802704/

An Exploration of the Interplay Between Caffeine and ... Caffeine exhibits MOA inhibition at high doses. Coadministration with a high dose of caffeine increases the risk of hypertension [31].

10. mdpi.com mdpi.com/1422-0067/24/24/17569

Caffeine and Its Interactions with Antiseizure Medications— ... Experimental studies reveal that caffeine (trimethylxanthine) at subconvulsive doses, distinctly reduced the anticonvulsant activity of numerous antiseizure ...