Healthy ParticipantsPhase 1NCT05924815
Study to Evaluate the Effect of Aficamten Administration on QT/QTc Interval
A Phase 1 study testing Aficamten and Moxifloxacin in people with Healthy Participants, run by Cytokinetics at 1 site in United States.
Trial summary
This is a single-center, 2-part (Part A and Part B) study in healthy participants. Part A (Dose Finding) is an open-label, SAD study to identify the dose for Part B. Part B (TQT Study) is a randomized, double-blind (with respect to aficamten and matching placebo), positive- and placebo-controlled, single-dose, 3-way… 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?
- Aficamten and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2023to 14 Nov 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, adult, male or female, 18-45 years of age, inclusive, at the screening visit.
- Continuous non-smoker who has not used nicotine- and tobacco -containing products for at least 3 months prior to the first dosing based on participant self- reporting.
- Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2 at the screening visit.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, and vital signs, as deemed by the PI or designee, including the following:
- Supine blood pressure is ≥ 90/40 mmHg and ≤ 140/90 mmHg at the screening visit.
- Oxygen saturation (SpO2) is ≥ 95% at the screening visit.
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- Liver function tests (e.g., bilirubin, aspartate aminotransferase [AST], alanine aminotransferase [ALT]) considered not clinically significant in the opinion of the PI or designee at the screening visit.
- Estimated creatinine clearance ≥ 90 mL/min at the screening visit.
- No clinically significant history and presence of ECG findings as judged by the PI or designee at the screening visit and first check-in, including each of the following:
- HR between 50 bpm and 100 bpm, inclusive.
- QTcF interval is ≤450 msec (males) and ≤460 msec (females).
- QRS ≤110 msec; if >110 msec, result will be confirmed by a manual over read.
- PR ≤220 msec.
- LVEF ≥65% at the screening visit.
Who cannot join
- History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
- History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, 2-Part, Single-Dose, Crossover Study to Evaluate the Effect of Aficamten Administration on QT/QTc Interval in Healthy Participants
This is a single-center, 2-part (Part A and Part B) study in healthy participants. Part A (Dose Finding) is an open-label, SAD study to identify the dose for Part B. Part B (TQT Study) is a randomized, double-blind (with respect to aficamten and matching placebo), positive- and placebo-controlled, single-dose, 3-way crossover study to evaluate the effect of aficamten administration on QT/QTc interval.
- Conditions
- Healthy Participants
- Being tested
- Aficamten, Aficamten-matching Placebo, Moxifloxacin
- Keywords
- CK-3773274, CK-274, Aficamten
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AficamtenDrug
Oral Tablet
Aficamten-matching PlaceboDrug
Oral Tablet
MoxifloxacinDrug
Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| Part A (Dose Finding Cohort 1): Aficamten 50 mg | Experimental | Participants in this arm will receive a single oral dose of 50 mg aficamten. Receives: Drug: Aficamten |
| Part A (Dose Finding Cohort 2): Aficamten 75 mg | Experimental | Participants in this arm will receive a single oral dose up to 75 mg aficamten. Receives: Drug: Aficamten |
| Part A (Dose Finding Cohort 3): Aficamten 100 mg | Experimental | Participants in this arm will receive a single oral dose up to 100 mg aficamten. Receives: Drug: Aficamten |
| Part B (TQT Study): Aficamten | Experimental | Participants will receive a single oral dose of aficamten. The dose will be determined based on review of Part A PK parameters, echocardiogram parameters, safety, and tolerability for aficamten. Receives: Drug: Aficamten |
| Part B (TQT Study): Aficamten-matching Placebo | Placebo comparator | Participants in this arm will receive a single oral dose of aficamten-matching placebo. Receives: Drug: Aficamten-matching Placebo |
| Part B (TQT Study): Moxifloxacin 400 mg | Active comparator | Participants will receive a single oral dose of 400 mg moxifloxacin Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: To determine the dose for Part B
To determine the dose for Part B based on Part A PK and safety data.
Measured: Baseline to End of Study, up to 8 weeks
Part B: placebo-corrected dQTcF for aficamten
To evaluate the effect of a single oral dose of aficamten on the QTc interval in healthy participants.
Measured: Baseline to End of Study, up to 14.5 weeks
Secondary outcomes (1)
Part B: placebo-corrected dQTcF for moxifloxacin
To demonstrate assay sensitivity of the study to detect a small QTc effect using moxifloxacin as a positive control in healthy participants.
Measured: Baseline to End of Study, up to 14.5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start15 May 2023
- Primary completion14 Nov 2023
- Study completion14 Nov 2023
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 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
- NCT05924815
- Sponsor's protocol ID
- CY 6019
- Status last verified
- Dec 2023
- First submitted
- 7 Jun 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, 2-Part, Single-Dose, Crossover Study to Evaluate the Effect of Aficamten Administration on QT/QTc Interval in Healthy Participants
- ClinicalTrials.gov ID
- NCT05924815
- Acronym / sponsor ID
- CY 6019
- Conditions
- Healthy Participants
- Keywords
- CK-3773274, CK-274, Aficamten
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- CytokineticsIndustry (pharma, biotech, devices)
- Study start
- 15 May 2023 (actual)
- Primary completion
- 14 Nov 2023 (actual)
- Study completion
- 14 Nov 2023 (actual)
- First posted
- 29 Jun 2023 (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.
This is a single-center, 2-part (Part A and Part B) study in healthy participants. Part A (Dose Finding) is an open-label, SAD study to identify the dose for Part B. Part B (TQT Study) is a randomized, double-blind (with respect to aficamten and matching placebo), positive- and placebo-controlled, single-dose, 3-way crossover study to evaluate the effect of aficamten administration on QT/QTc interval.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part A (Dose Finding Cohort 1): Aficamten 50 mg | Experimental | Drug: AficamtenParticipants in this arm will receive a single oral dose of 50 mg aficamten. |
| Part A (Dose Finding Cohort 2): Aficamten 75 mg | Experimental | Drug: AficamtenParticipants in this arm will receive a single oral dose up to 75 mg aficamten. |
| Part A (Dose Finding Cohort 3): Aficamten 100 mg | Experimental | Drug: AficamtenParticipants in this arm will receive a single oral dose up to 100 mg aficamten. |
| Part B (TQT Study): Aficamten | Experimental | Drug: AficamtenParticipants will receive a single oral dose of aficamten. The dose will be determined based on review of Part A PK parameters, echocardiogram parameters, safety, and tolerability for aficamten. |
| Part B (TQT Study): Aficamten-matching Placebo | Placebo comparator | Drug: Aficamten-matching PlaceboParticipants in this arm will receive a single oral dose of aficamten-matching placebo. |
| Part B (TQT Study): Moxifloxacin 400 mg | Active comparator | Drug: MoxifloxacinParticipants will receive a single oral dose of 400 mg moxifloxacin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Healthy, adult, male or female, 18-45 years of age, inclusive, at the screening visit.
- Continuous non-smoker who has not used nicotine- and tobacco -containing products for at least 3 months prior to the first dosing based on participant self- reporting.
- Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2 at the screening visit.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, and vital signs, as deemed by the PI or designee, including the following:
- No clinically significant history and presence of ECG findings as judged by the PI or designee at the screening visit and first check-in, including each of the following:
Key exclusion criteria (2 listed)
- History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
- History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing.
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 |
|---|---|---|
| AficamtenOral Tablet | Drug | Part A (Dose Finding Cohort 1): Aficamten 50 mg, Part A (Dose Finding Cohort 2): Aficamten 75 mg, Part A (Dose Finding Cohort 3): Aficamten 100 mg, Part B (TQT Study): Aficamten |
| Aficamten-matching PlaceboOral Tablet | Drug | Part B (TQT Study): Aficamten-matching Placebo |
| MoxifloxacinOral Tablet | Drug | Part B (TQT Study): Moxifloxacin 400 mg |
Primary outcome
Part A: To determine the dose for Part B
Time frame: Baseline to End of Study, up to 8 weeks
To determine the dose for Part B based on Part A PK and safety data.
Part B: placebo-corrected dQTcF for aficamten
Time frame: Baseline to End of Study, up to 14.5 weeks
To evaluate the effect of a single oral dose of aficamten on the QTc interval in healthy participants.
1 secondary outcome
Part B: placebo-corrected dQTcF for moxifloxacin
Time frame: Baseline to End of Study, up to 14.5 weeks
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 19 Dec 2023.
- Individual participant dataSharing planned: No
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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 Aficamten and Moxifloxacin 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 14 inclusion and 2 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 19 Dec 2023. 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 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?
Part A: To determine the dose for Part B (time frame: Baseline to End of Study, up to 8 weeks). 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?
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 19 Dec 2023.