Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CK-4021586 · 2 trials · 2 indications
Incidence of early drug discontinuation observed during dosing of CK 4021586 in patients with HFpEF
Incidence of left-ventricular ejection fraction (LVEF) \< 40% observed during dosing of CK-4021586 in patients with HFpEF
Incidence of adverse events observed during dosing of CK-4021586 in patients with HFpEF
To assess the safety and tolerability of CK-4021586 when administered orally as single or multiple doses to healthy participants
| Arm | Type | Description |
|---|---|---|
| CK-4021586 - Cohort 1 | EXPERIMENTAL | Participants may receive 150 mg or 300 mg of CK-4021586 daily, guided by echocardiography assessments, for 12 weeks total. |
| Placebo - Cohort 1 | PLACEBO_COMPARATOR | Participants will receive placebo daily for up to 12 weeks. |
| CK-4021586 - Cohort 2 | EXPERIMENTAL | Participants may receive 300 mg or 450 mg of CK-4021586 daily, guided by echocardiography assessments, for 12 weeks total. |
| Placebo - Cohort 2 | PLACEBO_COMPARATOR | Participants will receive placebo daily for up to 12 weeks. |
| CK-4021586 - Cohort 3 | EXPERIMENTAL | Participants may receive 450 mg or 600 mg of CK-4021586 daily, guided by echocardiography assessments, for 12 weeks total. |
| Placebo - Cohort 3 | PLACEBO_COMPARATOR | Participants will receive placebo daily for up to 12 weeks. |
| CK-4021586 for SAD Cohort | EXPERIMENTAL | Subjects will be assigned to one of 8 planned dose cohorts and receive single doses of 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 |
| CK-4021586 for MAD Cohort | EXPERIMENTAL | Subjects will be assigned to one of 4 planned dose cohorts and receive multiple doses of CK-4021586 |
| Placebo for MAD Cohort | PLACEBO_COMPARATOR | Subjects will be assigned to one of approximately 4 planned cohorts and receive multiple of placebo |
| Food Effect | EXPERIMENTAL | Healthy subjects will be administered CK-4021586 with and without food in a cross-over fashion |
| Name | Type | Description |
|---|---|---|
| CK-4021586 (150 mg, 300 mg, 450 mg, and 600 mg) | DRUG | CK-4021586 administered orally |
| Placebo to match CK-4021586 | DRUG | Placebo administered orally |
| CK-4021586 | DRUG | CK-4021586 |
| Placebo for CK-4021586 | DRUG | Placebo for CK-4021586 |
Inclusion Criteria: * Males and females ≥ 40 years and ≤ 85 years of age at screening. * Diagnosed with HF with NYHA functional class II or III. * Screening echocardiography with LVEF ≥ 60%. * Screening NT-proBNP ≥ 300 pg/mL for participants in sinus rhythm and ≥ 900 pg/mL for participants with com...
CK-4021586 is an investigational small molecule being studied for symptomatic heart failure with preserved ejection fraction (HFpEF). It is also being evaluated in healthy participants to assess its safety and tolerability. The drug is in clinical development and is not yet approved by the FDA.
CK-4021586 targets cardiac myosin, a protein involved in heart muscle contraction. By modulating cardiac myosin, the drug aims to affect heart function in conditions like heart failure with preserved ejection fraction (HFpEF). The exact mechanism of action is under investigation in clinical trials.
CK-4021586 is being developed by Cytokinetics, Incorporated, a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's safety, tolerability, and efficacy in healthy participants and in patients with symptomatic heart failure with preserved ejection fraction (HFpEF).
CK-4021586 is in Phase 1 and Phase 2 clinical development. A Phase 1 study in healthy participants has been completed, and a Phase 2 study in patients with symptomatic heart failure with preserved ejection fraction (HFpEF) is currently recruiting. The drug is investigational and not yet approved.
CK-4021586 is being studied in two clinical trials. NCT05877053 is a completed Phase 1 single and multiple ascending dose study in healthy participants. NCT06793371, known as AMBER-HFpEF, is a recruiting Phase 2 study evaluating safety and tolerability in patients with symptomatic heart failure with preserved ejection fraction (HFpEF).
CK-4021586 is also known by its dose strengths: 150 mg, 300 mg, 450 mg, and 600 mg. These refer to the same drug substance being tested in clinical trials. No other alternative names have been reported.