Healthy ParticipantsPhase 1NCT05877053
A Single and Multiple Ascending Dose Study of CK-4021586 in Healthy Adult Participants
A Phase 1 study testing CK-4021586 in people with Healthy Participants, run by Cytokinetics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- CK-4021586
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2023to 20 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Healthy Participants
- Being tested
- CK-4021586, Placebo for CK-4021586
- Keywords
- CK-586, CK-4021586
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CK-4021586Drug
CK-4021586
Placebo for CK-4021586Drug
Placebo for CK-4021586
| Study group | Role | What they receive |
|---|---|---|
| CK-4021586 for SAD Cohort | Experimental | Subjects will be assigned to one of 8 planned dose cohorts and receive single doses of CK-4021586 Receives: Drug: CK-4021586 |
| Placebo for SAD Cohort | Placebo comparator | Subjects will be assigned to one of approximately 8 planned cohorts and receive single doses of placebo Receives: Drug: Placebo for CK-4021586 |
| CK-4021586 for MAD Cohort | Experimental | Subjects will be assigned to one of 4 planned dose cohorts and receive multiple doses of CK-4021586 Receives: Drug: CK-4021586 |
| Placebo for MAD Cohort | Placebo comparator | Subjects will be assigned to one of approximately 4 planned cohorts and receive multiple of placebo Receives: Drug: Placebo for CK-4021586 |
| Food Effect | Experimental | Healthy subjects will be administered CK-4021586 with and without food in a cross-over fashion Receives: Drug: CK-4021586 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of AEs
To assess the safety and tolerability of CK-4021586 when administered orally as single or multiple doses to healthy participants
Measured: 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 (2)
Primary PK parameters of CK-4021586 including AUC
To characterize the PK of CK-4021586 and CK-4022235 after single and multiple oral doses in healthy participants
Measured: 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)
Changes over time from baseline in echocardiographic parameters including, but not limited to, LVEF
To characterize the PD effects of single and multiple oral doses of CK-4021586 in healthy participants
Measured: Time Frame for SAD Cohorts: Day -1 - Day 7; Time Frame for MAD Cohorts: Day -1 - Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start9 May 2023
- Primary completion20 Nov 2024
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytokinetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scientific Leadership at Cytokinetics, Study director, Cytokinetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877053
- Sponsor's protocol ID
- CY 9011
- Status last verified
- Apr 2025
- First submitted
- 17 May 2023
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lutz JD, Maharao N, Simkins T, Cheplo K, Liu G, Dumitrescu C, Griffith A, Sukhun R, Heitner SB, Kupfer S, German P. A First-in-Human Study of Ulacamten, a Novel Cardiac Myosin Inhibitor for HFpEF. Clin Pharmacokinet. 2026 Aug 30. doi: 10.1007/s40262-026-01694-6. Online ahead of print.
PubMed 42669735
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05877053
- Acronym / sponsor ID
- CY 9011
- Conditions
- Healthy Participants
- Keywords
- CK-586, CK-4021586
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- CytokineticsIndustry (pharma, biotech, devices)
- Study start
- 9 May 2023 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CK-4021586 for SAD Cohort | Experimental | Drug: CK-4021586Subjects will be assigned to one of 8 planned dose cohorts and receive single doses of CK-4021586 |
| Placebo for SAD Cohort | Placebo comparator | Drug: Placebo for CK-4021586Subjects will be assigned to one of approximately 8 planned cohorts and receive single doses of placebo |
| CK-4021586 for MAD Cohort | Experimental | Drug: CK-4021586Subjects will be assigned to one of 4 planned dose cohorts and receive multiple doses of CK-4021586 |
| Placebo for MAD Cohort | Placebo comparator | Drug: Placebo for CK-4021586Subjects will be assigned to one of approximately 4 planned cohorts and receive multiple of placebo |
| Food Effect | Experimental | Drug: CK-4021586Healthy subjects will be administered CK-4021586 with and without food in a cross-over fashion |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CK-4021586CK-4021586 | Drug | CK-4021586 for MAD Cohort, CK-4021586 for SAD Cohort, Food Effect |
| Placebo for CK-4021586Placebo for CK-4021586 | Drug | Placebo for MAD Cohort, Placebo for SAD Cohort |
Primary outcome
Incidence and severity of AEs
Time frame: 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)
To assess the safety and tolerability of CK-4021586 when administered orally as single or multiple doses to healthy participants
2 secondary outcomes
Primary PK parameters of CK-4021586 including AUC
Time frame: 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)
Changes over time from baseline in echocardiographic parameters including, but not limited to, LVEF
Time frame: Time Frame for SAD Cohorts: Day -1 - Day 7; Time Frame for MAD Cohorts: Day -1 - Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Derived from this study: PubMed 42669735Lutz JD, Maharao N, Simkins T, Cheplo K, Liu G, Dumitrescu C, Griffith A, Sukhun R, Heitner SB, Kupfer S, German P. A First-in-Human Study of Ulacamten, a Novel Cardiac Myosin Inhibitor for HFpEF. Clin Pharmacokinet. 2026 Aug 30. doi: 10.1007/s40262-026-01694-6. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scientific Leadership at Cytokinetics study director
Cytokinetics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CK-4021586 in people with Healthy Participants, run by Cytokinetics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of AEs (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05877053, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.