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

NCT06649942 | Completed Phase 1 FDA Drug

• 1 other identifier: KP-001-104
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy Volunteers - Male and Female

Keywords

Healty Adults

Outcome Measures

Primary Outcomes (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

  Before dosing (Baseline) through 24 hours

Secondary Outcomes (23)

• Placebo-corrected change from baseline in QTcF (ΔΔQTcF)

  Before dosing (Baseline) through 24 hours

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

  Before dosing (Baseline) through 24 hours

• Categorial outliers for QRS after KP-001 dosing

  Before dosing (Baseline) through 24 hours

• Placebo-corrected ΔHR after KP-001 dosing

  Before dosing (Baseline) through 24 hours

• Placebo-corrected ΔPR after KP-001 dosing

  Before dosing (Baseline) through 24 hours

Study Arms (4)

Treatment T

EXPERIMENTAL

KP-001 therapeutic dose (KP-001 100 mg + placebo)

Drug: KP-001

Treatment ST

EXPERIMENTAL

KP-001 supratherapeutic dose (KP-001 400 mg)

Drug: KP-001

Treatment M

ACTIVE COMPARATOR

moxifloxacin 400 mg

Drug: Moxifloxacin 400 mg

Treatment P

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

KP-001 DRUG

KP-001 100 mg + placebo

Treatment T

Moxifloxacin 400 mg DRUG

moxifloxacin 400 mg tablet

Treatment M

Placebo DRUG

Placebo

Treatment P

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Kaken Pharmaceutical: lead
• Parexel: collaborator

Study Sites (1)

Parexel Early Phase Clinical Unit - Los Angeles

Glendale, California, 91206, United States

Location

MeSH Terms

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 21, 2024
• Study Start: October 1, 2024
• Primary Completion: March 24, 2025
• Study Completion: March 24, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

US (1)