Clinical trial NCT05877053: A Single and Multiple Ascending Dose Study of CK-4021586 in Healthy Adult Participants
Official title: A Phase 1, Double-blind, Randomized, Placebo-controlled, Multi-part, Single and Multiple Ascending Dose Study of CK-4021586 in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: CK-586
CK-4021586
Lead sponsor: Cytokinetics
Sponsor class: INDUSTRY
First posted: 2023-05-26
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purposes of this study are to:

* Learn about the safety and tolerability of CK 4021586 after a single dose and multiple doses in healthy subjects.
* Find out how much CK-4021586 is in the blood after a single dose and multiple doses.
* Determine the effect different doses of CK-4021586 on the pumping function of the heart.
* Determine the effect of food in the stomach on how much CK-4021586 is in the blood after a single dose.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female participants aged between 18 and 55 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:

* Significant history or clinical manifestation of any significant metabolic, allergic/immunologic, dermatologic, hepatic, renal, hematologic, respiratory, cardiovascular (including arrhythmia), gastrointestinal, gallbladder/biliary, musculoskeletal, neurologic, or psychiatric disorder in the opinion of the Investigator or designee.
* History of significant hypersensitivity or allergy to any drug compound or other substance, unless approved by the Investigator and the Sponsor's Medical Monitor.
* 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).
* Participants with breast implants that may impede echocardiography
* Clinically significant illness within 4 weeks prior to check in.
* Significant ECG abnormalities (heart block, prolonged QT interval, arrhythmia)
* History of, or current substance abuse (drug or alcohol), known drug or alcohol dependence within the last 2 years prior to Screening, or positive test for drugs of abuse during the screening period
* Any acute or chronic condition that would limit the participant's ability to complete and/or participate in this clinical study, in the judgment of the Investigator

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-4021586 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
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion
state: Arizona
Study officials:
affiliation: Cytokinetics
name: Scientific Leadership at Cytokinetics
role: STUDY_DIRECTOR
References: