A Study to Evaluate the Effects of KP-001 on the QT/QTc Intervals in Healthy Adults (NCT06649942) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate the Effects of KP-001 on the QT/QTc Intervals in Healthy Adults
United States40 participantsStarted 2024-10-01
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. 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.
What they're measuring
1
Largest time-matched placebo-corrected change from baseline in QTcF (ΔΔQTcF) collected in a 24-hour period after KP-001 single dosing
Timeframe: Before dosing (Baseline) through 24 hours
✓. Participant has body weight ≥ 50.0 kg and body mass index within the range 18.0 to 30.0 kg/m2, inclusive, at screening.
Exclusion criteria
✕. 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.