Healthy ParticipantsPhase 1NCT05662215
A Single and Multiple Ascending Dose Study of CK-3828136 in Healthy Adult Participants
A Phase 1 study testing CK-3828136 in people with Healthy Participants, run by Cytokinetics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- CK-3828136
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2022to 8 Aug 2023
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 of any significant illness or disorder.
- 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).
- History or presence of:
- additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome).
- sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, pulmonary congestion, symptomatic or significant cardiac arrhythmia, prolonged QTcF interval, or clinically significant conduction abnormalities.
- Clinically significant illness within 4 weeks prior to check in.
- Participants with an inability to swallow tablets.
Trial locations and contacts
1 site in 1 country.
United States1 site
Labcorp Clinical Research Unit Inc.
Dallas, Texas, 75247
About this study
Official title: 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
- 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.
- Conditions
- Healthy Participants
- Being tested
- CK-3828136, Placebo for CK-3828136
- Keywords
- CK-3828136, CK-136
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CK-3828136Drug
CK-3828136
Placebo for CK-3828136Drug
Placebo for CK-3828136
| Study group | Role | What they receive |
|---|---|---|
| CK-3828136 for SAD Cohort | Experimental | Subjects will be assigned to one of approximately 8 planned dose cohorts and receive single doses of CK-3828136 Receives: Drug: CK-3828136 |
| 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-3828136 |
| CK-3828136 for MAD Cohort | Experimental | Subjects will be assigned to one of approximately 8 planned dose cohorts and receive multiple doses of CK-3828136 Receives: Drug: CK-3828136 |
| Placebo for MAD 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-3828136 |
| Food Effect | Experimental | Healthy subjects will be administered CK-3828136 with and without food in a cross-over fashion. Receives: Drug: CK-3828136 |
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-3828136 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 (3)
Primary PK parameters of CK-3828136 including AUC
To characterize the PK of CK-3828136 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-3828136 in healthy participants Time Frame for SAD Cohorts: Day -1 - Day 7; Time Frame for MAD Cohorts: Day -1 - Day 14
Measured: 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
Measured: Time Frame for Food Effect Cohort: Days 1 to 7 (Treatment Periods 1 and 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start6 Dec 2022
- Primary completion8 Aug 2023
- Study completion8 Aug 2023
Why it stopped: Terminated early per sponsor decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytokinetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cytokinetics, MD, Study director, Cytokinetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662215
- Sponsor's protocol ID
- CY 8011
- Status last verified
- Oct 2024
- First submitted
- 7 Dec 2022
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05662215
- Acronym / sponsor ID
- CY 8011
- Conditions
- Healthy Participants
- Keywords
- CK-3828136, CK-136
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated early per sponsor decision.
- Enrolment
- 57 participants (actual)
- Lead sponsor
- CytokineticsIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- 8 Aug 2023 (actual)
- Study completion
- 8 Aug 2023 (actual)
- First posted
- 22 Dec 2022 (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.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CK-3828136 for SAD Cohort | Experimental | Drug: CK-3828136Subjects will be assigned to one of approximately 8 planned dose cohorts and receive single doses of CK-3828136 |
| Placebo for SAD Cohort | Placebo comparator | Drug: Placebo for CK-3828136Subjects will be assigned to one of approximately 8 planned cohorts and receive single doses of placebo |
| CK-3828136 for MAD Cohort | Experimental | Drug: CK-3828136Subjects will be assigned to one of approximately 8 planned dose cohorts and receive multiple doses of CK-3828136 |
| Placebo for MAD Cohort | Placebo comparator | Drug: Placebo for CK-3828136Subjects will be assigned to one of approximately 8 planned cohorts and receive single doses of placebo |
| Food Effect | Experimental | Drug: CK-3828136Healthy subjects will be administered CK-3828136 with and without food in a cross-over fashion. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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 of any significant illness or disorder.
- 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).
- History or presence of:
- 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-3828136CK-3828136 | Drug | CK-3828136 for MAD Cohort, CK-3828136 for SAD Cohort, Food Effect |
| Placebo for CK-3828136Placebo for CK-3828136 | 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-3828136 when administered orally as single or multiple doses to healthy participants
3 secondary outcomes
Primary PK parameters of CK-3828136 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
PK parameters calculated using plasma CK-3828136 concentrations including AUC in fed and fasted state
Time frame: Time Frame for Food Effect Cohort: Days 1 to 7 (Treatment Periods 1 and 2)
Results and safety
The study was stopped early (reason given: Terminated early per sponsor decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
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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.
Cytokinetics, MD 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-3828136 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: stopped early, as of the sponsor's last update on 17 Oct 2024. 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 was stopped early (reason given: Terminated early per sponsor decision.). Results are not available in the source record.
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?
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 17 Oct 2024.