A Single and Multiple Ascending Dose Study of CK-3828136 in Healthy Adult Participants

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK-3828136 in Healthy Participants

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05662215

Enrollment

Registered

2022-12-22

Start date

2022-12-06

Completion date

2023-08-08

Last updated

2024-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

Keywords

CK-3828136, CK-136

Brief summary

1. Learn about the safety and tolerability of CK-3828136 after a single dose and multiple doses in healthy subjects. 2. Find out how much CK-3828136 is in the blood after a single dose and multiple doses. 3. Determine the effect different doses of CK-3828136 on the pumping function of the heart.

Interventions

DRUGPlacebo for CK-3828136

Placebo for CK-3828136

DRUGCK-3828136

CK-3828136

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male and female participants aged between 18 and 45 years (inclusive) with a body mass index between 18.0 and 30.0 kg/m2 (inclusive), with a body weight \> 50.0 kg.

Exclusion criteria

Participants will not be enrolled in the study if they meet any of the following

Design outcomes

Primary

Measure	Time frame	Description
Incidence and severity of AEs	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-3828136 when administered orally as single or multiple doses to healthy participants

Secondary

Measure	Time frame	Description
Primary PK parameters of CK-3828136 including AUC	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 characterize the PK of CK-3828136 after single and multiple oral doses in healthy participants
Changes over time from baseline in echocardiographic parameters including, but not limited to, LVEF	Time Frame for SAD Cohorts: Day -1 - Day 7; Time Frame for MAD Cohorts: Day -1 - Day 14	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
PK parameters calculated using plasma CK-3828136 concentrations including AUC in fed and fasted state	Time Frame for Food Effect Cohort: Days 1 to 7 (Treatment Periods 1 and 2)	PK parameters following single multiple doses in fed and fasted state

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026