Ignite Creation Date:
2024-10-25 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06649942
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
A Study to Evaluate the Effects of KP-001 on the QTQTc Intervals in Healthy Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Single-blind Placebo-controlled Four-way Crossover Thorough QT Study to Investigate the Effect of KP-001 on the QTQTc Interval Using Open-label Moxifloxacin as an Active Control in Adult Healthy Volunteers
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 1 single-center randomized single-blind participants are blinded placebo controlled four-way cross over TQT study 44 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 mannerTotal 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
KP-001 and placebo dry syrup will be administered in blinded manner to participants and the moxifloxacin tablet will be administered in open-label mannerTotal 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
Detailed Description:
This is a Phase 1 single-center randomized single-blind participants are blinded placebo controlled four-way cross over TQT study 44 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 1111 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
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 1111 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None