AzTrials
AzTrials

Healthy Volunteers - Male and FemalePhase 1NCT06649942

A Study to Evaluate the Effects of KP-001 on the QT/QTc Intervals in Healthy Adults

A Phase 1 study testing KP-001 and Moxifloxacin 400 mg in people with Healthy Volunteers - Male and Female, run by Kaken Pharmaceutical at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a Phase 1, single-center, randomized, single-blind (participants are blinded), placebo controlled, four-way cross over TQT study (4×4 Williams square design) to investigate the effect of KP-001 on the QTc interval using open-label moxifloxacin as an active control, in adult healthy volunteers. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers - Male and Female
What is being tested?
KP-001 and Moxifloxacin 400 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
1 Oct 2024to 24 Mar 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

  • Participant voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to performing any of the Screening Visit procedures.
  • Males and females between 18 to 55 years of age, inclusive, at the Screening Visit.
  • A female participant is eligible to participate if she is a WONCBP and is 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 must agree not to donate sperm from the first dose until 91 days after the last dose of KP-001.
  • 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.
  • Participant 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.
  • Participant has body weight ≥ 50.0 kg and body mass index within the range 18.0 to 30.0 kg/m2, inclusive, at screening.

Who cannot join

  • An uninterpretable or abnormal screening and first check-in ECG indicating a second- or third-degree atrioventricular block, or one or more of the following: QRS interval \>110 msec; QTcF \>450 msec, PR interval \>200 msec; HR \<40 bpm; T wave abnormalities, or any rhythm other than sinus rhythm that is interpreted by the Principal Investigator and/or qualified designee to be clinically significant.
  • History of risk factors for Torsades de Pointes, including unexplained syncope, known long QT syndrome, heart failure, myocardial infarction, angina, or clinically significant abnormal laboratory assessments including hypokalemia, hypercalcemia, or hypomagnesemia. Participants will also be excluded if there is a family history of long QT syndrome or Brugada syndrome, or family history of sudden cardiac death prior to the age of 40.
  • A sustained supine systolic blood pressure \>140 mmHg or \<90 mmHg or a supine diastolic blood pressure \>90 mmHg or \<50 mmHg at screening. A sustained supine systolic blood pressure \>150 mmHg or \<90 mmHg or a supine diastolic blood pressure \>95 mmHg or \<50 mmHg at check-in.
  • A resting HR of \<40 bpm or \>100 bpm when vital signs are measured at screening or check in.
  • Unstable cardiovascular disease, including recent myocardial infarction or cardiac arrhythmia.
  • Participant 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.
Show all 30Show fewer
  • Participant has a significant history or clinical manifestation of any metabolic, allergic, dermatologic, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder as determined by the Investigator or designee.
  • Participant has 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.
  • Participant used any prescription or non-prescription medications (including vitamins, recreational drugs, and dietary or herbal supplements) within 14 days or five 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.
  • Participant underwent blood donation or transfusion within 56 days prior to Day -1 of Treatment Period 1 and throughout the study.
  • Participant has 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.
  • Participant has enrolled in a previous clinical study with KP-001 medication.
  • Participant has 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).
  • Participant has a complication of drug allergies or history of drug allergies.
  • Participant used any investigational drug in the last 30 days or five half-lives (if known), whichever is longer, prior to Day -1 of Treatment Period 1.
  • Participant had any major illness within 30 days before the Screening Visit.
  • Participant had any major surgical procedure within 30 days prior to Day -1 of Treatment Period 1 or any planned surgery during study period.
  • Participant 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.
  • Participant has abnormal findings on the screening ECG deemed clinically significant by the Investigator or qualified designee.
  • Participant 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.
  • Participant has consumed alcohol- or caffeine-containing foods and beverages 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.
  • Participant has positive urine drug or urine alcohol and positive cotinine test results at screening or Day -1 of Treatment Period 1.
  • Participant 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.
  • Participant 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.
  • Participant is unable or unwilling to undergo multiple venipunctures.
  • Participant has a history or presence of liver disease or cholecystectomy within one year prior to screening.
  • Participant has an HbA1c \>5.7% at screening.
  • Participant has positive results at screening for human immunodeficiency virus, hepatitis B core antibody, hepatitis B surface antigen or hepatitis C virus.
  • Participant has a disorder or any condition that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
  • Participant has 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 Early Phase Clinical Unit - Los Angeles

    Glendale, California, 91206

Other trials in United States

About this study

Official title: A Randomized, Single-blind, Placebo-controlled, Four-way Crossover Thorough QT Study to Investigate the Effect of KP-001 on the QT/QTc Interval Using Open-label Moxifloxacin as an Active Control, in Adult Healthy Volunteers

This is a Phase 1, single-center, randomized, single-blind (participants are blinded), placebo controlled, four-way cross over TQT study (4×4 Williams square design) to investigate the effect of KP-001 on the QTc interval using open-label moxifloxacin as an active control, in adult healthy volunteers.

KP-001 and placebo (dry syrup) will be administered in blinded manner to participants, and the moxifloxacin (tablet) will be administered in open-label manner.Total duration of study participation for each participant is approximately 8 weeks.

Cardiodynamic ECG evaluations will be performed at separate locations and cardiodynamic ECG evaluators will be blinded to treatment group analyzed, ie, blinded to each of the study interventions including moxifloxacin.

Read the detailed description

This is a Phase 1, single-center, randomized, single-blind (participants are blinded), placebo controlled, four-way cross over TQT study (4×4 Williams square design) to investigate the effect of KP-001 on the QTc interval using open-label moxifloxacin as an active control, in adult healthy volunteers.

KP-001 and placebo (dry syrup) will be administered in blinded manner to participants, and the moxifloxacin (tablet) will be administered in open-label manner.

The study will comprise the following:

  • Treatment Periods 1, 2, 3, and 4: For each period, participants will be residential at the Clinical Unit from the day before the dose of study intervention (Day 1 of each treatment period) until 3 days after the dose of study intervention (Day 4 of each treatment period). Participants will receive a single dose of study intervention each period, in accordance with the assigned treatment sequence .
  • Washout: at least 7 days between administrations of each study intervention. Total duration of study participation for each participant is approximately 8 weeks.

On Day 1 of Treatment Period 1, participants will be randomly assigned in a 1:1:1:1 ratio to one of the four treatment sequences and administrated a single oral dose of one of the following four treatments under fasting condition:

  • KP-001 therapeutic dose (T): KP-001 100 mg + placebo
  • KP-001 supratherapeutic dose (ST): KP-001 400 mg
  • Placebo (P): placebo dry syrup
  • Moxifloxacin (M): moxifloxacin 400 mg tablet

Cardiodynamic ECG evaluations will be performed at separate locations and cardiodynamic ECG evaluators will be blinded to treatment group analyzed, ie, blinded to each of the study interventions including moxifloxacin.

Being tested
KP-001, Moxifloxacin 400 mg, Placebo
Keywords
Healty Adults

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 + placebo

  • KP-001Drug

    KP-001 400 mg

  • Moxifloxacin 400 mgDrug

    moxifloxacin 400 mg tablet

  • PlaceboDrug

    Placebo

Study groups in NCT06649942
Study groupRoleWhat they receive
Treatment TExperimentalKP-001 therapeutic dose (KP-001 100 mg + placebo)
Receives: Drug: KP-001
Treatment STExperimentalKP-001 supratherapeutic dose (KP-001 400 mg)
Receives: Drug: KP-001
Treatment MActive comparatormoxifloxacin 400 mg
Receives: Drug: Moxifloxacin 400 mg
Treatment PPlacebo comparatorplacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Largest time-matched placebo-corrected change from baseline in QTcF (ΔΔQTcF) collected in a 24-hour period after KP-001 single dosing

    To evaluate the effect of KP-001 as single therapeutic and supratherapeutic dose on the QTcF interval

    Measured: Before dosing (Baseline) through 24 hours

Secondary outcomes (23)

  1. Placebo-corrected change from baseline in QTcF (ΔΔQTcF)

    To study the concentration-response relationship between KP-001 concentrations after dosing and ΔQTcF (C-ΔQTcF model)

    Measured: Before dosing (Baseline) through 24 hours

  2. Largest time-matched placebo-corrected change from baseline in QTcF (ΔΔQTcF) after moxifloxacin dosing

    Largest time-matched placebo-corrected change from baseline in QTcF (ΔΔQTcF) collected in a 24-hour period after moxifloxacin dosing

    Measured: Before dosing (Baseline) through 24 hours

  3. Categorial outliers for QRS after KP-001 dosing

    Measured: Before dosing (Baseline) through 24 hours

  4. Placebo-corrected ΔHR after KP-001 dosing

    Measured: Before dosing (Baseline) through 24 hours

  5. Placebo-corrected ΔPR after KP-001 dosing

    Measured: Before dosing (Baseline) through 24 hours

  6. Placebo-corrected ΔQRS after KP-001 dosing

    Measured: Before dosing (Baseline) through 24 hours

  7. Categorial outliers for PR after KP-001 dosing

    Measured: Before dosing (Baseline) through 24 hours

  8. Categorial outliers for HR after KP-001 dosing

    Measured: Before dosing (Baseline) through 24 hours

  9. Categorial outliers for QTcF after KP-001 dosing

    Measured: Before dosing (Baseline) through 24 hours

  10. Change from baseline PR after KP-001 dosing

    Measured: Before dosing (Baseline) through 24 hours

  11. Change from baseline HR after KP-001 dosing

    Measured: Before dosing (Baseline) through 24 hours

  12. PK parameters of KP-001 in plasma: CLtot/F

    Measured: pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 36 and 72 hours post-dose

  13. PK parameters of KP-001 in plasma: Tmax

    To evaluate PK of KP-001

    Measured: pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose

  14. PK parameters of KP-001 in plasma: t1/2

    To evaluate PK of KP-001

    Measured: pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose

  15. PK parameters of KP-001 in plasma: Vz/F

    To evaluate PK of KP-001

    Measured: pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose

  16. Frequency of treatment-emergent morphology and appearance of U-wave after KP-001 dosing

    Measured: Before dosing (Baseline) through 24 hours

  17. PK parameters of KP-001 in plasma: Cmax

    To evaluate PK of KP-001

    Measured: pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose

  18. Frequency of treatment-emergent changes in Twave morphology after KP-001 dosing

    Measured: Before dosing (Baseline) through 24 hours

  19. PK parameters of KP-001 in plasma: AUC0-24

    Measured: pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose

  20. PK parameters of KP-001 in plasma: AUC0-48

    Measured: pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose

  21. PK parameters of KP-001 in plasma: AUC0-72

    Measured: pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose

  22. PK parameters of KP-001 in plasma: AUCinf

    Area Under the Concentration Time-curve From Time Zero to Infinity for KP-001

    Measured: pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose

  23. Placebo-corrected change from baseline in QTcF (ΔΔQTcF) predicted from the C-ΔQTcF model at Cmax

    To study the concentration-response relationship between KP-001 concentrations

    Measured: Before dosing (Baseline) through 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2024
  2. Study start1 Oct 2024
  3. Primary completion24 Mar 2025
  4. Study completion24 Mar 2025

Resources

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
Crossover
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06649942
Sponsor's protocol ID
KP-001-104
Status last verified
Sep 2025
First submitted
26 Sep 2024
Last updated
17 Sep 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KP-001 and Moxifloxacin 400 mg in people with Healthy Volunteers - Male and Female, 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 8 inclusion and 30 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 17 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. Some participants in this study may receive a placebo. 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?

Largest time-matched placebo-corrected change from baseline in QTcF (ΔΔQTcF) collected in a 24-hour period after KP-001 single dosing (time frame: Before dosing (Baseline) through 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06649942.

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 17 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in