A Phase 1 interventional study of CK-3828136 and Placebo for CK-3828136 in Healthy Participants, sponsored by Cytokinetics. Terminated at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-17.
Sponsored by Cytokinetics · Phase 1, Interventional, and Basic science
Cytokinetics is the lead sponsor of 41 studies on the registry; 3 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 7 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will not be enrolled in the study if they meet any of the following exclusion criteria at the screening visit, unless otherwise stated:
History or presence of:
Subjects will be assigned to one of approximately 8 planned dose cohorts and receive single doses of CK-3828136
Drug: CK-3828136
Subjects will be assigned to one of approximately 8 planned cohorts and receive single doses of placebo
Drug: Placebo for CK-3828136
Subjects will be assigned to one of approximately 8 planned dose cohorts and receive multiple doses of CK-3828136
Drug: CK-3828136
Subjects will be assigned to one of approximately 8 planned cohorts and receive single doses of placebo
Drug: Placebo for CK-3828136
Healthy subjects will be administered CK-3828136 with and without food in a cross-over fashion.
Drug: CK-3828136
CK-3828136
Placebo for CK-3828136
Incidence and severity of AEs
To assess the safety and tolerability of CK-3828136 when administered orally as single or multiple doses to healthy participants
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)
Primary PK parameters of CK-3828136 including AUC
To characterize the PK of CK-3828136 after single and multiple oral doses in healthy participants
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
To characterize the PD effects of single and multiple oral doses of CK-3828136 in healthy participants Time Frame for SAD Cohorts: Day -1 - Day 7; Time Frame for MAD Cohorts: Day -1 - Day 14
Time frame: Time Frame for SAD Cohorts: Day -1 - Day 7; Time Frame for MAD Cohorts: Day -1 - Day 14
PK parameters calculated using plasma CK-3828136 concentrations including AUC in fed and fasted state
PK parameters following single multiple doses in fed and fasted state
Time frame: Time Frame for Food Effect Cohort: Days 1 to 7 (Treatment Periods 1 and 2)
This study is terminated, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Cytokinetics