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

• Register: ClinicalTrials.gov
• Last refreshed on: 3 February 2025
• Main ID: NCT03767855
• Date of registration: 03/12/2018
• Prospective Registration: Yes
• Primary sponsor: Cytokinetics
• Public title: A Single and Multiple Ascending Dose Study of CK-3773274 in Healthy Adult Subjects
• Scientific title: A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Multi-Part, Single and Multiple Ascending Dose Study of CK-3773274 in Healthy Adult Subjects
• Date of first enrolment: December 4, 2018
• Target sample size: 114
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03767855
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Basic Science. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Study Director MD
• Affiliation: Cytokinetics

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Males and females (of non-childbearing potential) between 18 and 55 years of age,
inclusive

2. Body weight > 55.0 kg and body mass index within 18.0 to 32.0 kg/m2, inclusive

3. Normal cardiac structure and function, or if abnormalities are present, they are
deemed not clinically significant

4. Normal to high left ventricular ejection fraction.

5. Normal electrocardiogram (ECG) or, if abnormalities are present, they are deemed not
clinically significant

6. Clinical laboratory findings within normal range

7. Negative hepatitis panel (including hepatitis B surface antigen and hepatitis C
antibody), and negative human immunodeficiency virus antibody screens

8. Willing and able to refrain from strenuous exercise (eg, activity which could be
expected to cause muscle soreness)

9. For Arms 5 and 6 only: Subject is a CYP2D6 poor metabolizer

Exclusion Criteria:

1. History of any significant illness or disorder

2. History of stomach or intestinal surgery or resection (appendectomy, hernia repair,
and/or cholecystectomy will be allowed)

3. A clinically significant illness within 4 weeks of Check-in

4. Inability to swallow capsules or tablets

5. 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

6. Use of any tobacco-containing or nicotine-containing products within 3 months prior
to Check-in

7. Participation in any other investigational study drug trial in which receipt of an
investigational study drug occurred within 30 days prior to Check-in

8. 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


Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy Subjects

Symptomatic Obstructive Hypertrophic Cardiomyopathy

Intervention(s)

Drug: CK-3773274 - Granules in Capsule

Drug: CK-3773274 - Tablets

Drug: Placebo - Granules in Capsule

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

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]

Assess the effect of a meal on how much CK-3773274 is in the blood in healthy subjects [Time Frame: Day -1 - Day 24]

Assess the effect of CYP2D6 genetic variants on the PK of CK-3773274 [Time Frame: Day -1 - Day 24]

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]

Secondary ID(s)

CY 6011

Source(s) of Monetary Support

Please refer to primary and secondary sponsors