CK-3828136 for SAD Cohort for Healthy Subjects

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Healthy SubjectsCK-3828136 - Drug
Eligibility
18 - 45
All Sexes
What conditions do you have?
Select

Study Summary

Learn about the safety and tolerability of CK-3828136 after a single dose and multiple doses in healthy subjects. Find out how much CK-3828136 is in the blood after a single dose and multiple doses. Determine the effect different doses of CK-3828136 on the pumping function of the heart.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Time Frame for Food Effect Cohort: Days 1 to 7 (Treatment Periods 1 and 2)

Day 1
PK parameters calculated using plasma CK-3828136 concentrations including AUC in fed and fasted state
Day 14
Changes over time from baseline in echocardiographic parameters including, but not limited to, LVEF
Day 14
Incidence and severity of AEs
Primary PK parameters of CK-3828136 including AUC

Trial Safety

Trial Design

5 Treatment Groups

CK-3828136 for SAD Cohort
1 of 5
CK-3828136 for MAD Cohort
1 of 5
Food Effect
1 of 5
Placebo for SAD Cohort
1 of 5
Placebo for MAD Cohort
1 of 5

Experimental Treatment

Non-Treatment Group

78 Total Participants · 5 Treatment Groups

Primary Treatment: CK-3828136 for SAD Cohort · Has Placebo Group · Phase 1

CK-3828136 for SAD Cohort
Drug
Experimental Group · 1 Intervention: CK-3828136 · Intervention Types: Drug
CK-3828136 for MAD Cohort
Drug
Experimental Group · 1 Intervention: CK-3828136 · Intervention Types: Drug
Food Effect
Drug
Experimental Group · 1 Intervention: CK-3828136 · Intervention Types: Drug
Placebo for SAD Cohort
Drug
PlaceboComparator Group · 1 Intervention: Placebo for CK-3828136 · Intervention Types: Drug
Placebo for MAD Cohort
Drug
PlaceboComparator Group · 1 Intervention: Placebo for CK-3828136 · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: time frame for food effect cohort: days 1 to 7 (treatment periods 1 and 2)

Who is running the clinical trial?

CytokineticsLead Sponsor
36 Previous Clinical Trials
14,548 Total Patients Enrolled
Cytokinetics, MDStudy DirectorCytokinetics
4 Previous Clinical Trials
1,226 Total Patients Enrolled

Eligibility Criteria

Age 18 - 45 · All Participants · 1 Total Inclusion Criteria

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Who else is applying?

What state do they live in?
Texas100.0%
What site did they apply to?
Labcorp Clinical Research Unit Inc.100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%