Clinical trial NCT05662215: A Single and Multiple Ascending Dose Study of CK-3828136 in Healthy Adult Participants
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK-3828136 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: CK-3828136, CK-136
Lead sponsor: Cytokinetics
Sponsor class: INDUSTRY
First posted: 2022-12-22
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: 1. Learn about the safety and tolerability of CK-3828136 after a single dose and multiple doses in healthy subjects.
2. Find out how much CK-3828136 is in the blood after a single dose and multiple doses.
3. Determine the effect different doses of CK-3828136 on the pumping function of the heart.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female participants aged between 18 and 45 years (inclusive) with a body mass index between 18.0 and 30.0 kg/m2 (inclusive), with a body weight \> 50.0 kg.

Exclusion Criteria:

Participants will not be enrolled in the study if they meet any of the following exclusion criteria at the screening visit, unless otherwise stated:

* History of any significant illness or disorder.
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, hernia repair, and/or cholecystectomy will be allowed).
* History or presence of:

  1. additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome).
  2. sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, pulmonary congestion, symptomatic or significant cardiac arrhythmia, prolonged QTcF interval, or clinically significant conduction abnormalities.
* Clinically significant illness within 4 weeks prior to check in.
* Participants with an inability to swallow tablets.

Primary outcomes:
measure: Incidence and severity of AEs
timeFrame: Time Frame for SAD Cohorts: Day -1 - Day 7; Time Frame for MAD Cohorts: Day -1 - Day 14; Time Frame for Food Effect Cohorts: Days 1 to 7 (Treatment Periods 1 and 2)
Secondary outcomes:
measure: Primary PK parameters of CK-3828136 including AUC
timeFrame: Time Frame for SAD Cohorts: Day -1 - Day 7; Time Frame for MAD Cohorts: Day -1 - Day 14; Time Frame for Food Effect Cohorts: Days 1 to 7 (Treatment Periods 1 and 2)
measure: Changes over time from baseline in echocardiographic parameters including, but not limited to, LVEF
timeFrame: Time Frame for SAD Cohorts: Day -1 - Day 7; Time Frame for MAD Cohorts: Day -1 - Day 14
measure: PK parameters calculated using plasma CK-3828136 concentrations including AUC in fed and fasted state
timeFrame: Time Frame for Food Effect Cohort: Days 1 to 7 (Treatment Periods 1 and 2)
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Labcorp Clinical Research Unit Inc.
state: Texas
Study officials:
affiliation: Cytokinetics
name: Cytokinetics, MD
role: STUDY_DIRECTOR
References: