Systolic Heart FailurePhase 1NCT03534297
Study of Dapansutrile Capsules in Heart Failure
A Phase 1 study testing dapansutrile capsules in people with Systolic Heart Failure, run by Olatec Therapeutics, Inc. at 1 site in United States.
Trial summary
This is a Phase 1b randomized, double-blinded, single-center safety and pharmacodynamics study of sequential cohort, dose-escalating, repeat-dosing of dapansutrile or placebo (4:1 ratio) in subjects with stable systolic heart failure (HF) with LVEF≤40% symptomatic for NYHA functional classification II-III who show… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systolic Heart Failure
- What is being tested?
- dapansutrile capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2018to 21 Nov 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects 18 years old or older
- Symptomatic stable HF (NYHA class II-III) with reduced left ventricular ejection fraction (LVEF≤40%, measured within 6 months of enrollment - no changes in cardiac medications or new device implantation within past 2 months)
- Peak exercise limited by shortness of breath and/or fatigue associated with a respiratory exchange ratio (RER) > 1.00 (reflecting maximal aerobic effort)
- Reduced peak aerobic exercise capacity (peak VO2) to less than 80% of predicted value by age/gender at Baseline
- Plasma CRP or hsCRP levels > 2 mg/L at Screening
- Acceptable overall medical condition to be safely enrolled in and to complete the study (with specific regard to cardiovascular, renal and hepatic conditions) in the opinion of the Principal Investigator
- Ability to provide written, informed consent prior to initiation of any study-related procedures, and ability, in the opinion of the Principal Investigator, to understand and comply with all the requirements of the study
Who cannot join
- Women of childbearing potential, or men whose sexual partner(s) is a woman of childbearing potential who:
- Are or intend to become pregnant (including use of fertility drugs) during the study
- Are nursing
- Are not using an acceptable, highly effective method of contraception until all follow-up procedures are complete. (Acceptable, highly effective forms of contraception are defined as: oral contraception, intrauterine device, systemic [injectable or patch] contraception, double barrier methods, naturally or surgically sterile, strict abstinence or partner has been sterilized. If hormonal-based birth control is being used, subject or subject's sexual partner(s) must be on a stable-dose for ≥ 3 months prior to the Baseline visit and maintained at the same dosing level throughout the study.)
- Abnormal blood pressure or heart rate response, angina or ECG changes (ischemia or arrhythmias) occurring during CPX
- Presence or known history of autoimmune conditions (e.g., systemic lupus erythematosus, hypophysitis, etc.)
Show all 27Show fewer
- History or evidence of active tuberculosis (TB) infection at Baseline visit or one of the risk factors for tuberculosis such as but not limited or exclusive to:
- History of any of the following: residence in a congregate setting (e.g., jail or prison, homeless shelter, or chronic care facility), substance abuse (e.g., injection or non-injection), health-care workers with unprotected exposure to subjects who are at high risk of TB or subjects with TB disease before the identification and correct airborne precautions of the subject or
- Close contact (i.e., share the same air space in a household or other enclosed environment for a prolonged period (days or weeks, not minutes or hours)) with a person with active pulmonary TB disease within the last 12 months.
- Use of any prohibited concomitant medications/therapies over the periods defined in Section 5.6.3 or planned use of any prohibited concomitant medications/therapies during the Treatment Period
- Any other concomitant medical or psychiatric condition(s), disease(s) or prior surgery(ies) that, in the opinion of the Principal Investigator, would impair the subject from safely participating in the trial and/or completing protocol requirements, including but not limited to:
- physical inability to walk on a treadmill
- decompensated HF (edema, NYHA IV)
- significant ischemic heart disease, angina
- arterial hypotension (blood pressure [BP] systolic < 90 mmHg)
- arterial hypertension (resting BP systolic > 160 mmHg)
- atrial fibrillation with rapid ventricular response
- severe valvular disease
- severe chronic obstructive or restrictive pulmonary disease
- moderate-severe anemia (Hgb < 10 g/dL)
- severe diabetic neuropathy or myopathy
- Active or recent (within 2 weeks) infection prior to the Baseline visit
- History of or known positive for HIV, Hepatitis B surface antigen or antibodies to Hepatitis C Virus
- Known history of renal impairment and/or creatinine clearance less than 50 mL/min calculated by Cockcroft-Gault method
- Active malignancy or recent malignancy with chemotherapy treatment within the past 6 months
- Enrollment in any trial and/or use of any investigational product or device within the immediate 30-day period prior to the Baseline visit
- Previous exposure to the investigational product
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University - Pauley Heart Center
Richmond, Virginia, 23298
About this study
Official title: A Phase 1b, Randomized, Double-Blinded, Dose Escalation, Single Center, Repeat-Dose Safety and Pharmacodynamics Study of Orally Administered Dapansutrile Capsules in Subjects With NYHA II-III Systolic Heart Failure
This is a Phase 1b randomized, double-blinded, single-center safety and pharmacodynamics study of sequential cohort, dose-escalating, repeat-dosing of dapansutrile or placebo (4:1 ratio) in subjects with stable systolic heart failure (HF) with LVEF≤40% symptomatic for NYHA functional classification II-III who show signs of systemic inflammation (high sensitivity plasma C reactive protein [hsCRP] > 2 mg/L). A total of 30 subjects will be enrolled in 3 sequential cohorts by randomized allocation (8 active and 2 placebo within each cohort). Progression to cohort 2 with dose escalation will occur following the Day 28 visit of the last subject in the first cohort. Progression to cohort 3 with dose escalation will occur following the Day 8 visit of the last subject in the second cohort.
Subjects will be screened and evaluated twice for eligibility: 1) at the time of Screening (up to 28 days prior to enrollment); and 2) at the Baseline visit, prior to randomization. Following enrollment, Baseline assessments will be conducted and the first dose of investigational product (either dapansutrile capsules or placebo capsules) will be administered at the clinical site upon completion of all assessment and collection of baseline parameters. Subjects will then self-administer investigational product once, twice or four times daily, depending on cohort, for up to fourteen (14) consecutive days beginning at the Baseline visit and continuing through the planned Day 14 visit. Subjects will return to the study clinic on Days 4, 8, 14 and 28 for follow-up visits. Additionally, subjects will be contacted for telephone follow-up on Day 42.
- Conditions
- Systolic Heart Failure
- Being tested
- dapansutrile capsules, Placebo capsules
- Keywords
- heart failure, systolic heart failure
- Medical subject headings
- Heart Failure, Systolic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dapansutrile capsulesDrug
Also called OLT1177 capsules
Hard opaque capsules containing 100 mg of API.
Placebo capsulesDrug
Hard opaque capsules containing 0 mg of API.
| Study group | Role | What they receive |
|---|---|---|
| dapansutrile capsules | Experimental | A total of 8 patients in each cohort will receive dapansutrile capsules:
* Cohort 1 will receive 5x 100 mg dapansutrile capsules QD for 14 days
* Cohort 2 will receive 5x 100 mg dapansutrile capsules BID for 14 days
* Cohort 3 will receive 5x 100 mg dapansutrile capsules QID for 14 days Receives: Drug: dapansutrile capsules |
| Placebo Capsules | Placebo comparator | A total of 2 patients in each cohort will receive placebo capsules:
* Cohort 1 will receive 5 placebo capsules QD for 14 days
* Cohort 2 will receive 5 placebo capsules BID for 14 days
* Cohort 3 will receive 5 placebo capsules QID for 14 days Receives: Drug: Placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Adverse events experienced by the patient will be recorded.
Measured: Screening through Day 42 follow-up
Secondary outcomes (15)
Cardiopulmonary exercise test
Physician-supervised maximal aerobic exercise test will be administered using a metabolic cart that is interfaced with a motorized treadmill. Change in peak oxygen consumption in each group will be assessed.
Measured: Day 14
Transthoracic Doppler ECG - Left Ventricle Ejection Fraction
Changes in left ventricular ejection fraction will be analyzed.
Measured: Day 14
Transthoracic Doppler ECG - Left Ventricular Filling Pressure
Changes in estimated left ventricular filling pressure, measured as ratio of early diastolic transmitral pulsed wave Doppler flow velocity (E) to tissue Doppler velocity of the mitral annulus (e') will be analyzed.
Measured: Day 14
Bioimpedance analysis
Bioimpedance is a non-invasive, quick and safe technique that allows to estimate body composition compartments (total body water, intracellular water, extracellular water, fat mass, fat-free mass, lean mass). Change in total body water will be assessed.
Measured: Day 14
Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score
Change in KCCQ score, a 23-item, self-administered instrument that independently measures a patient's perception of their health status, which includes heart failure symptoms. This scale is quantified in six domains: physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Each domain is scored on a 0-100 scale with 100 being better and 0 being worse. Two summary scores are calculated: the Clinical Summary Score (mean of symptom and physical function domain scores) and the Overall Summary Score (mean of the symptom, physical function, social limitations and quality of life scores).
Measured: Day 14
Kansas City Cardiomyopathy Questionnaire - Overall Summary Score
Change in KCCQ score, a 23-item, self-administered instrument that independently measures a patient's perception of their health status, which includes heart failure symptoms. This scale is quantified in six domains: physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Each domain is scored on a 0-100 scale with 100 being better and 0 being worse. Two summary scores are calculated: the Clinical Summary Score (mean of symptom and physical function domain scores) and the Overall Summary Score (mean of the symptom, physical function, social limitations and quality of life scores).
Measured: Day 14
Duke Activity Status Index
Change in Duke Activity Status Index, a self-administered questionnaire that measures a patient's functional capacity. The index consists of 12 "yes or no" questions, which are summed and used to calculate VO2peak and METS.
Measured: Day 14
Vital signs - Pulse
Changes in pulse will be analyzed.
Measured: Day 14
Vital signs - Blood Pressure
Changes in systolic and diastolic blood pressure will be analyzed.
Measured: Day 14
Vital signs - Temperature
Changes in body temperature will be analyzed.
Measured: Day 14
Vital signs - Respiratory Rate
Changes in respiratory rate will be analyzed.
Measured: Day 14
Safety Laboratory Measurements - Chemistry
Changes in blood chemistry will be analyzed.
Measured: Day 14
Safety Laboratory Measurements - Hematology
Changes in complete blood count will be analyzed.
Measured: Day 14
Physical Examination
A full or targeted physical examination of the patient's major body systems
Measured: Day 14
12-lead electrocardiogram
Electrodes will be placed on the patient to obtain a recording of the electrical activity of the heart.
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start16 May 2018
- Primary completion21 Nov 2019
- Study completion21 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Systolic Heart FailureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be assigned to receive either dapansutrile capsules or placebo capsules in a 4:1 ratio within each Cohort.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olatec Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534297
- Sponsor's protocol ID
- OLT1177-06
- Status last verified
- Jan 2020
- First submitted
- 21 Dec 2017
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Baat A, Trinh B, Ellingsgaard H, Donath MY. Physiological role of cytokines in the regulation of mammalian metabolism. Trends Immunol. 2023 Aug;44(8):613-627. doi: 10.1016/j.it.2023.06.002. Epub 2023 Jul 7.
PubMed 37423882Wohlford GF, Van Tassell BW, Billingsley HE, Kadariya D, Canada JM, Carbone S, Mihalick VL, Bonaventura A, Vecchie A, Chiabrando JG, Bressi E, Thomas G, Ho AC, Marawan AA, Dell M, Trankle CR, Turlington J, Markley R, Abbate A. Phase 1B, Randomized, Double-Blinded, Dose Escalation, Single-Center, Repeat Dose Safety and Pharmacodynamics Study of the Oral NLRP3 Inhibitor Dapansutrile in Subjects With NYHA II-III Systolic Heart Failure. J Cardiovasc Pharmacol. 2020 Oct 24;77(1):49-60. doi: 10.1097/FJC.0000000000000931.
PubMed 33235030
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Randomized, Double-Blinded, Dose Escalation, Single Center, Repeat-Dose Safety and Pharmacodynamics Study of Orally Administered Dapansutrile Capsules in Subjects With NYHA II-III Systolic Heart Failure
- ClinicalTrials.gov ID
- NCT03534297
- Acronym / sponsor ID
- OLT1177-06
- Conditions
- Systolic Heart Failure
- Keywords
- heart failure, systolic heart failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Olatec Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 May 2018 (actual)
- Primary completion
- 21 Nov 2019 (actual)
- Study completion
- 21 Nov 2019 (actual)
- First posted
- 23 May 2018 (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 Phase 1b randomized, double-blinded, single-center safety and pharmacodynamics study of sequential cohort, dose-escalating, repeat-dosing of dapansutrile or placebo (4:1 ratio) in subjects with stable systolic heart failure (HF) with LVEF≤40% symptomatic for NYHA functional classification II-III who show signs of systemic inflammation (high sensitivity plasma C reactive protein [hsCRP] > 2 mg/L). A total of 30 subjects will be enrolled in 3 sequential cohorts by randomized allocation (8 active and 2 placebo within each cohort). Progression to cohort 2 with dose escalation will occur following the Day 28 visit of the last subject in the first cohort. Progression to cohort 3 with dose escalation will occur following the Day 8 visit of the last subject in the second cohort.
Subjects will be screened and evaluated twice for eligibility: 1) at the time of Screening (up to 28 days prior to enrollment); and 2) at the Baseline visit, prior to randomization. Following enrollment, Baseline assessments will be conducted and the first dose of investigational product (either dapansutrile capsules or placebo capsules) will be administered at the clinical site upon completion of all assessment and collection of baseline parameters. Subjects will then self-administer investigational product once, twice or four times daily, depending on cohort, for up to fourteen (14) consecutive days beginning at the Baseline visit and continuing through the planned Day 14 visit. Subjects will return to the study clinic on Days 4, 8, 14 and 28 for follow-up visits. Additionally, subjects will be contacted for telephone follow-up on Day 42.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Subjects will be assigned to receive either dapansutrile capsules or placebo capsules in a 4:1 ratio within each Cohort.
| Arm | Type | Receives |
|---|---|---|
| dapansutrile capsules | Experimental | Drug: dapansutrile capsulesA total of 8 patients in each cohort will receive dapansutrile capsules: * Cohort 1 will receive 5x 100 mg dapansutrile capsules QD for 14 days * Cohort 2 will receive 5x 100 mg dapansutrile capsules BID for 14 days * Cohort 3 will receive 5x 100 mg dapansutrile capsules QID for 14 days |
| Placebo Capsules | Placebo comparator | Drug: Placebo capsulesA total of 2 patients in each cohort will receive placebo capsules: * Cohort 1 will receive 5 placebo capsules QD for 14 days * Cohort 2 will receive 5 placebo capsules BID for 14 days * Cohort 3 will receive 5 placebo capsules QID for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female subjects 18 years old or older
- Symptomatic stable HF (NYHA class II-III) with reduced left ventricular ejection fraction (LVEF≤40%, measured within 6 months of enrollment - no changes in cardiac medications or new device implantation within past 2 months)
- Peak exercise limited by shortness of breath and/or fatigue associated with a respiratory exchange ratio (RER) > 1.00 (reflecting maximal aerobic effort)
- Reduced peak aerobic exercise capacity (peak VO2) to less than 80% of predicted value by age/gender at Baseline
- Plasma CRP or hsCRP levels > 2 mg/L at Screening
Key exclusion criteria (27 listed)
- Women of childbearing potential, or men whose sexual partner(s) is a woman of childbearing potential who:
- Abnormal blood pressure or heart rate response, angina or ECG changes (ischemia or arrhythmias) occurring during CPX
- Presence or known history of autoimmune conditions (e.g., systemic lupus erythematosus, hypophysitis, etc.)
- History or evidence of active tuberculosis (TB) infection at Baseline visit or one of the risk factors for tuberculosis such as but not limited or exclusive to:
- Use of any prohibited concomitant medications/therapies over the periods defined in Section 5.6.3 or planned use of any prohibited concomitant medications/therapies during the Treatment Period
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 |
|---|---|---|
| dapansutrile capsulesAlso: OLT1177 capsulesHard opaque capsules containing 100 mg of API. | Drug | dapansutrile capsules |
| Placebo capsulesHard opaque capsules containing 0 mg of API. | Drug | Placebo Capsules |
Primary outcome
Adverse events
Time frame: Screening through Day 42 follow-up
Adverse events experienced by the patient will be recorded.
15 secondary outcomes
Cardiopulmonary exercise test
Time frame: Day 14
Transthoracic Doppler ECG - Left Ventricle Ejection Fraction
Time frame: Day 14
Transthoracic Doppler ECG - Left Ventricular Filling Pressure
Time frame: Day 14
Bioimpedance analysis
Time frame: Day 14
Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score
Time frame: Day 14
Kansas City Cardiomyopathy Questionnaire - Overall Summary Score
Time frame: Day 14
Duke Activity Status Index
Time frame: Day 14
Vital signs - Pulse
Time frame: Day 14
Vital signs - Blood Pressure
Time frame: Day 14
Vital signs - Temperature
Time frame: Day 14
Vital signs - Respiratory Rate
Time frame: Day 14
Safety Laboratory Measurements - Chemistry
Time frame: Day 14
Safety Laboratory Measurements - Hematology
Time frame: Day 14
Physical Examination
Time frame: Day 14
12-lead electrocardiogram
Time frame: Day 8
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 9 Jan 2020.
- Derived from this study: PubMed 37423882de Baat A, Trinh B, Ellingsgaard H, Donath MY. Physiological role of cytokines in the regulation of mammalian metabolism. Trends Immunol. 2023 Aug;44(8):613-627. doi: 10.1016/j.it.2023.06.002. Epub 2023 Jul 7.
- Derived from this study: PubMed 33235030Wohlford GF, Van Tassell BW, Billingsley HE, Kadariya D, Canada JM, Carbone S, Mihalick VL, Bonaventura A, Vecchie A, Chiabrando JG, Bressi E, Thomas G, Ho AC, Marawan AA, Dell M, Trankle CR, Turlington J, Markley R, Abbate A. Phase 1B, Randomized, Double-Blinded, Dose Escalation, Single-Center, Repeat Dose Safety and Pharmacodynamics Study of the Oral NLRP3 Inhibitor Dapansutrile in Subjects With NYHA II-III Systolic Heart Failure. J Cardiovasc Pharmacol. 2020 Oct 24;77(1):49-60. doi: 10.1097/FJC.0000000000000931.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 dapansutrile capsules in people with Systolic Heart Failure, run by Olatec Therapeutics, Inc. 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 7 inclusion and 27 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 9 Jan 2020. 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?
Adverse events (time frame: Screening through Day 42 follow-up). 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 NCT03534297, which also lists 2 linked publications.
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 9 Jan 2020.