A Single and Multiple Ascending Dose Study of CK-3773274 in Healthy Adult Subjects
NCT ID: NCT03767855
Last Updated: 2025-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
114 participants
INTERVENTIONAL
2018-12-04
2020-01-03
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
BASIC_SCIENCE
TRIPLE
Study Groups
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CK-3773274 for SAD Cohorts
Subjects will be assigned to one of 8 planned dose cohorts and receive single doses of CK-3773274
CK-3773274 - Granules in Capsule
CK-3773274 formulated as granules in capsule
Placebo for SAD Cohorts
Subjects will be assigned to one of 8 planned dose cohorts and receive single doses of placebo
Placebo - Granules in Capsule
Placebo formulated as granules in capsule
CK-3773274 for MAD Cohorts
Subjects will be assigned to one of 3 planned dose cohorts and receive multiple doses of CK-3773274
CK-3773274 - Granules in Capsule
CK-3773274 formulated as granules in capsule
Placebo for MAD Cohorts
Subjects will be assigned to one of 3 planned dose cohorts and receive multiple doses of placebo
Placebo - Granules in Capsule
Placebo formulated as granules in capsule
CK-3773274 for CYP2D6 Cohort
Subjects with CYP2D6 poor metabolizer phenotype will be assigned to receive a single dose of CK-3773274
CK-3773274 - Granules in Capsule
CK-3773274 formulated as granules in capsule
Placebo for CYP2D6 Cohort
Subjects with CYP2D6 poor metabolizer phenotype will be assigned to receive a single dose of placebo
Placebo - Granules in Capsule
Placebo formulated as granules in capsule
Food Effect
Subjects will be administered CK-3773274 with and without food in a randomized cross-over fashion
CK-3773274 - Granules in Capsule
CK-3773274 formulated as granules in capsule
Relative Bioavailability
Subjects will be administered CK-3773274 as granules in a capsule and as a tablet in a randomized cross-over fashion.
CK-3773274 - Granules in Capsule
CK-3773274 formulated as granules in capsule
CK-3773274 - Tablets
CK-3773274 formulated as tablets
Interventions
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CK-3773274 - Granules in Capsule
CK-3773274 formulated as granules in capsule
Placebo - Granules in Capsule
Placebo formulated as granules in capsule
CK-3773274 - Tablets
CK-3773274 formulated as tablets
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
55 Years
ALL
Yes
Sponsors
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Cytokinetics
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director MD
Role: STUDY_DIRECTOR
Cytokinetics
Locations
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Clinical Site
Tempe, Arizona, United States
Countries
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References
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Malik FI, Robertson LA, Armas DR, Robbie EP, Osmukhina A, Xu D, Li H, Solomon SD. A Phase 1 Dose-Escalation Study of the Cardiac Myosin Inhibitor Aficamten in Healthy Participants. JACC Basic Transl Sci. 2022 Aug 10;7(8):763-775. doi: 10.1016/j.jacbts.2022.04.008. eCollection 2022 Aug.
Other Identifiers
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CY 6011
Identifier Type: -
Identifier Source: org_study_id
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