Obstructive Hypertrophic CardiomyopathyPhase 1NCT04783766
Safety, Tolerability and Pharmacokinetics Study of CK-3773274
A Phase 1 study testing CK-3773274 in people with Obstructive Hypertrophic Cardiomyopathy and Healthy Adult Subjects, run by Corxel Pharmaceuticals at 1 site in China.
Trial summary
The purposes of this study are to: 1. Learn about the safety of CK-3773274 after a single dose and multiple doses in Chinese healthy adult subjects. 2. Learn how healthy subjects tolerate CK-3773274 after a single dose and multiple doses. 3. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Hypertrophic Cardiomyopathy, Healthy Adult Subjects
- What is being tested?
- CK-3773274
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2021to 5 Aug 2021
- 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 Chinese males and females between 18 and 45 years of age, inclusive
- Body weight ≥50kg and body mass index (BMI) within 18 to 26 kg/m2, inclusive
- Acoustic windows adequate for accurate transthoracic echocardiograms
- Normal cardiac structure and function, as determined by the cardiologist, or if abnormalities are present, the finding is not clinically significant as determined by the cardiologist
- LVEF ≥65 percent at screening, and LVEF ≥60 percent at Day-1
- Normal ECG
Who cannot join
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
- Subjects with breast implants that may impede echocardiography
- A clinically significant illness within 4 weeks prior to admission to the CRU
- Inability to swallow tablets
- Use of alcohol-containing, grapefruit-containing, or caffeine-containing foods or beverages within 48 hours prior to admission to the CRU
- Poor peripheral venous access
- Any blood donation within 60 days prior to admission to the CRU, or any plasma donation within 30 days prior to admission to the CRU, or receipt of blood products within 2 months prior to admission to the CRU
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of CK-3773274 in Healthy Chinese Subjects
The purposes of this study are to:
- Learn about the safety of CK-3773274 after a single dose and multiple doses in Chinese healthy adult subjects.
- Learn how healthy subjects tolerate CK-3773274 after a single dose and multiple doses.
- Find out how much CK-3773274 is in the blood after a single dose and multiple doses.
- Determine the effect of doses of CK-3773274 on the pumping function of the heart.
- Evaluate the effect CYP2D6 genetic polymorphisms on how the body metabolizes CK-3773274.
- Being tested
- CK-3773274, Placebo
- Keywords
- CK-274, Obstructive hypertrophic cardiomyopathy, CK-3773274, oHCM, aficamten
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CK-3773274Drug
CK-3773274- Tablets
PlaceboDrug
Placebo- Tablets
| Study group | Role | What they receive |
|---|---|---|
| CK-3773274 for Single Ascending Dose (SAD) Cohorts | Experimental | Subjects will be assigned to one of 2 planned dose cohorts and receive single doses of CK-3773274 Receives: Drug: CK-3773274 |
| Placebo comparator for SAD Cohorts | Placebo comparator | Subjects will be assigned to one of 2 planned dose cohorts and receive single doses of placebo comparator Receives: Drug: Placebo |
| CK-3773274 for Multiple Dose (MD) Cohort | Experimental | Subjects will receive multiple doses of CK-3773274 Receives: Drug: CK-3773274 |
| Placebo comparator for MD Cohort | Placebo comparator | Subjects will receive multiple doses of placebo comparator Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject incidence of Adverse Event (AE), Serious Adverse Event (SAE)
Measured: SAD cohorts: Day-1 - Day10; MD cohort: Day-1 - Day 23
Reduced Left Ventricular Ejection Fraction (LVEF)
Measured: SAD cohorts: Day-1 - Day10; MD cohort: Day-1 - Day 23
Secondary outcomes (1)
Cmax of CK-3773274 after single and multiple ascending doses
Measured: SAD Cohorts: Day-1 - Day10; MD Cohort: Day-1 - Day 23
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start10 Apr 2021
- Primary completion5 Aug 2021
- Study completion5 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Hypertrophic CardiomyopathyStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corxel Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cytokinetics
- Responsible party
- Sponsor
- Investigators
- Chen, MD, Study director, Corxel Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783766
- Sponsor's protocol ID
- JX01001
- Other IDs
- CTR20210291
- Status last verified
- Jan 2025
- First submitted
- 3 Mar 2021
- Last updated
- 24 Jan 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Zhao X, Liu H, Tian W, Fang L, Yu M, Wu X, Liu A, Wan R, Li L, Luo J, Li Y, Liu B, He Y, Chen X, Li Y, Xu D, Wang H, Han X. Safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of aficamten in healthy Chinese participants: a randomized, double-blind, placebo-controlled, phase 1 study. Front Pharmacol. 2023 Aug 23;14:1227470. doi: 10.3389/fphar.2023.1227470. eCollection 2023.
PubMed 37680714
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of CK-3773274 in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT04783766
- Acronym / sponsor ID
- JX01001
- Keywords
- CK-274, Obstructive hypertrophic cardiomyopathy, CK-3773274, oHCM, aficamten
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Corxel PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Cytokinetics
- Study start
- 10 Apr 2021 (actual)
- Primary completion
- 5 Aug 2021 (actual)
- Study completion
- 5 Aug 2021 (actual)
- First posted
- 5 Mar 2021 (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.
The purposes of this study are to:
- Learn about the safety of CK-3773274 after a single dose and multiple doses in Chinese healthy adult subjects.
- Learn how healthy subjects tolerate CK-3773274 after a single dose and multiple doses.
- Find out how much CK-3773274 is in the blood after a single dose and multiple doses.
- Determine the effect of doses of CK-3773274 on the pumping function of the heart.
- Evaluate the effect CYP2D6 genetic polymorphisms on how the body metabolizes CK-3773274.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CK-3773274 for Single Ascending Dose (SAD) Cohorts | Experimental | Drug: CK-3773274Subjects will be assigned to one of 2 planned dose cohorts and receive single doses of CK-3773274 |
| Placebo comparator for SAD Cohorts | Placebo comparator | Drug: PlaceboSubjects will be assigned to one of 2 planned dose cohorts and receive single doses of placebo comparator |
| CK-3773274 for Multiple Dose (MD) Cohort | Experimental | Drug: CK-3773274Subjects will receive multiple doses of CK-3773274 |
| Placebo comparator for MD Cohort | Placebo comparator | Drug: PlaceboSubjects will receive multiple doses of placebo comparator |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy Chinese males and females between 18 and 45 years of age, inclusive
- Body weight ≥50kg and body mass index (BMI) within 18 to 26 kg/m2, inclusive
- Acoustic windows adequate for accurate transthoracic echocardiograms
- Normal cardiac structure and function, as determined by the cardiologist, or if abnormalities are present, the finding is not clinically significant as determined by the cardiologist
- LVEF ≥65 percent at screening, and LVEF ≥60 percent at Day-1
Key exclusion criteria (7 listed)
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
- Subjects with breast implants that may impede echocardiography
- A clinically significant illness within 4 weeks prior to admission to the CRU
- Inability to swallow tablets
- Use of alcohol-containing, grapefruit-containing, or caffeine-containing foods or beverages within 48 hours prior to admission to the CRU
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-3773274CK-3773274- Tablets | Drug | CK-3773274 for Multiple Dose (MD) Cohort, CK-3773274 for Single Ascending Dose (SAD) Cohorts |
| PlaceboPlacebo- Tablets | Drug | Placebo comparator for MD Cohort, Placebo comparator for SAD Cohorts |
Primary outcome
Subject incidence of Adverse Event (AE), Serious Adverse Event (SAE)
Time frame: SAD cohorts: Day-1 - Day10; MD cohort: Day-1 - Day 23
Reduced Left Ventricular Ejection Fraction (LVEF)
Time frame: SAD cohorts: Day-1 - Day10; MD cohort: Day-1 - Day 23
1 secondary outcome
Cmax of CK-3773274 after single and multiple ascending doses
Time frame: SAD Cohorts: Day-1 - Day10; MD Cohort: Day-1 - Day 23
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Derived from this study: PubMed 37680714Zhao X, Liu H, Tian W, Fang L, Yu M, Wu X, Liu A, Wan R, Li L, Luo J, Li Y, Liu B, He Y, Chen X, Li Y, Xu D, Wang H, Han X. Safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of aficamten in healthy Chinese participants: a randomized, double-blind, placebo-controlled, phase 1 study. Front Pharmacol. 2023 Aug 23;14:1227470. doi: 10.3389/fphar.2023.1227470. eCollection 2023.
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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.
Chen, MD study director
Corxel Pharmaceuticals
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-3773274 in people with Obstructive Hypertrophic Cardiomyopathy and Healthy Adult Subjects, run by Corxel Pharmaceuticals at 1 site in China.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 24 Jan 2025. 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 China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Subject incidence of Adverse Event (AE), Serious Adverse Event (SAE) (time frame: SAD cohorts: Day-1 - Day10; MD cohort: Day-1 - Day 23). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04783766, which also lists 1 linked publication.
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 24 Jan 2025.