New drug KP-001 tested for interactions with common meds
NCT ID NCT06821698
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This completed Phase 1 study looked at how a new drug called KP-001 interacts with other medications in 38 healthy adults. The study measured how KP-001 affects the body's processing of rosuvastatin (a cholesterol drug) and caffeine, and how fluvoxamine (an antidepressant) affects KP-001 levels. The goal was to understand potential drug interactions, not to treat any disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- KP-001
- What this could lead to
- If successful, this study could help determine safe dosing for KP-001 when taken with other common drugs.
- What could go wrong
- This is a very early, small study in healthy volunteers, not patients. It only looks at drug levels in the blood, not whether KP-001 works for any disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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38 people
The number who actually took part.
- Started
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Feb 2025
- Finished
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May 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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. 2. A male or female participant who is between 18 to 55 years of age, inclusive, at the Screening Visit. 3. (Part 1 only) A participant who is non-Asian. 4. A female participant who is non-childbearing potential defined in Section 10.4 and not pregnant or breastfeeding. 5. 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. 6. A male participant who agrees not to donate sperm from the first dose until 91 days after the last dose of KP-001. 7. 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. 8. 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. 9. 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. Exclusion Criteria: 1. 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. 2. 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. 3. 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. 4. (For Part 3 only) A participant who meets any of the following criteria based on the C-SSRS assessment at screening: 1. 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) 2. Any lifetime history of suicidal ideation (an answer of "yes" on Questions 4 or 5 of the C-SSRS Baseline/Screening version). 3. Any lifetime history of suicidal behavior as detected by the C-SSRS Baseline/Screening version. 5. 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. 6. A participant who underwent blood donation or transfusion within 56 days prior to Day -1 of Treatment Period 1 and throughout the study. 7. 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. 8. 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. 9. A participant who has enrolled in any clinical study of KP-001. 10. A participant with a complication of drug allergies or a history of drug allergies. 11. 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. 12. A participant who had any major illness within 30 days before the Screening Visit. 13. 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. 14. 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. 15. A participant with abnormal findings on the screening ECG deemed clinically significant by the Investigator or qualified designee. 16. 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. 17. (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. 18. A participant with positive urine drug or urine alcohol and positive cotinine test results at screening or Day -1 of Treatment Period 1. 19. 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. 20. 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. 21. A participant who is unable or unwilling to undergo multiple venipunctures. 22. A participant with a history or presence of liver disease or cholecystectomy within one year prior to screening. 23. A participant with an HbA1c \>5.7% at screening. 24. A participant with positive results at screening for human immunodeficiency virus, hepatitis B core antibody, hepatitis B surface antigen or hepatitis C virus. 25. A participant with a disorder or any condition that would interfere with the absorption, distribution, metabolism, or excretion of drugs. 26. A participant with an eGFR calculated using the CKD-EPI formula \<80 mL/min at screening.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Parexel International Early Phase Clinical Unit
Glendale, California, 91206, United States
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