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Completed

NCT Number: NCT03767855

A Single and Multiple Ascending Dose Study of CK-3773274 in Healthy Adult Subjects

The purposes of this study are to:

1. Learn about the safety of CK-3773274 after a single dose and multiple doses in healthy subjects. 2. Learn how healthy subjects tolerate CK-3773274 after a single dose and multiple doses. 3. Find out how much CK-3773274 is in the blood after a single dose and multiple doses. 4. Determine the effect of doses of CK-3773274 on the pumping function of the heart. 5. Evaluate the effect of cytochrome genetic variants on how the body metabolizes CK-3773274. 6. Evaluate the effect of a meal on how much CK-3773274 is in the blood in healthy adult subjects. 7. Evaluate whether the amount of CK-3773274 in the blood is the similar for both the tablet and granules in capsule forms of the drug.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Site

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females (of non-childbearing potential) between 18 and 55 years of age, inclusive
  • Body weight > 55.0 kg and body mass index within 18.0 to 32.0 kg/m2, inclusive
  • Normal cardiac structure and function, or if abnormalities are present, they are deemed not clinically significant
  • Normal to high left ventricular ejection fraction.
  • Normal electrocardiogram (ECG) or, if abnormalities are present, they are deemed not clinically significant
  • Clinical laboratory findings within normal range
  • Negative hepatitis panel (including hepatitis B surface antigen and hepatitis C antibody), and negative human immunodeficiency virus antibody screens
  • Willing and able to refrain from strenuous exercise (eg, activity which could be expected to cause muscle soreness)
  • For Arms 5 and 6 only: Subject is a CYP2D6 poor metabolizer

Exclusion criteria

  • History of any significant illness or disorder
  • History of stomach or intestinal surgery or resection (appendectomy, hernia repair, and/or cholecystectomy will be allowed)
  • A clinically significant illness within 4 weeks of Check-in
  • Inability to swallow capsules or tablets
  • 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
  • Use of any tobacco-containing or nicotine-containing products within 3 months prior to Check-in
  • Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days prior to Check-in
  • Any blood donation within 60 days of dosing, plasma donation within 30 days of dosing, or receipt of blood products within 2 months prior to Check-in

Treatment and study plan

CK-3773274 - Granules in Capsule

Drug

CK-3773274 formulated as granules in capsule

Placebo - Granules in Capsule

Drug

Placebo formulated as granules in capsule

CK-3773274 - Tablets

Drug

CK-3773274 formulated as tablets

Primary outcomes

  1. Incidence of Adverse events and Safety Signals observed during single and multiple ascending doses of CK-3773274 administered orally to healthy adult subjects.

    Time frame: SAD Cohorts: Day -1 - Day 10; CYP2D6 Cohort: Day -1 - Day - 24; MAD Cohorts: Day -1 - Day 27; Food Effect Cohort: Day -1 - Day 24; relative Bioavailability Cohort: Day -1 - Day 29

    Subject incidence of AEs, SAEs, and reduced LVEF

Secondary outcomes

  1. Cmax of CK-3773274 after single and multiple ascending doses

    Time frame: SAD Cohorts: Day 1; CYP2D6 Cohort: Day 1; MAD Cohorts: Day 14 or Day 17; Food Effect Cohort: Day 15; Relative Bioavailability Cohort: Day 15

    Maximum concentration after dosing (Cmax) following single and multiple doses of CK-3773274 administered to healthy subjects

  2. Change in absolute reduction in ejection fraction relative to baseline with doses of CK-3773274

    Time frame: Time Frame for SAD Cohorts: Day -1 - Day 10; Time Frame for CYP2D6 Cohort: Day -1 - Day 24; Time Frame for MAD Cohorts: Day -1 - Day 27

    Changes from baseline in LVEF as measured by echocardiography with doses of CK-3773274

  3. Assess the effect of CYP2D6 genetic variants on the PK of CK-3773274

    Time frame: Day -1 - Day 24

    Maximum concentration after dosing (Cmax) following a single dose administered to CYP2D6 poor metabolizers

  4. Assess the effect of a meal on how much CK-3773274 is in the blood in healthy subjects

    Time frame: Day -1 - Day 24

    Maximum concentration after dosing (Cmax) following single and multiple doses of CK-3773274 administered to healthy subjects in fed and fasted states

  5. Relative bioavailability of CK-3773274 formulated as granules in capsule versus a tablet in healthy adult subjects

    Time frame: Time Frame for Bioavailability Cohort: Day -1 - Day 29

    PK parameters such as AUC calculated using plasma concentrations of CK-3773274

Sponsors and collaborators

Lead sponsor

Cytokinetics

Industry

Registry information

Official study title

A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Multi-Part, Single and Multiple Ascending Dose Study of CK-3773274 in Healthy Adult Subjects

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 7, 2018
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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