None listed
Conditions
Brief summary
The intention of the trial is to study the pharmacokinetics (PK) of CRD-102 in patients with heart failure following 30 days of administration. It is hypothesized that CRD-102 is able to improve heart function and quality of life. Prior to conducting a phase 2 trial, Cardiora needs to better understand the PK profile of CRD-102, how it is absorbed and cleared from the body. This trial intends to study the PK effects of different doses of CRD-102. A dose of 14 mg twice daily will be administered to up to 15 patients, and following this 18mg twice daily will be trialled.
Interventions
There are 2 arms to this study. Each arm will enrol up to 15 patients. Patients will be assigned to be administered 14mg twice daily of CRD-102, or 18mg of CRD-102 twice daily.
Patients will be administered CRD-102 for 30 days prior to a PK study that will be done on day 30.
CRD-102 will be administered as a capsule. Patients will be dispensed adequate supply of medication when the study commences. Any unused tablets will need to be returned - thus ensuring compliance. Laboratory tests to meas
There are 2 arms to this study. Each arm will enrol up to 15 patients. Patients will be assigned to be administered 14mg twice daily of CRD-102, or 18mg of CRD-102 twice daily. Patients will be administered CRD-102 for 30 days prior to a PK study that will be done on day 30. CRD-102 will be administered as a capsule. Patients will be dispensed adequate supply of medication when the study commences. Any unused tablets will need to be returned - thus ensuring compliance. Laboratory tests to measure levels on day 30 will give an indication of plasma levels at baseline. There will also be an outpatient visit during the trial, where patient will be reminded to be compliant to study treatment regime. An additional 3rd arm of up to 15 patients may be enrolled if required following an interim analysis. The 3rd arm will receive oral CRD-102 twice daily for 30 days at a dose to be determined based on interim analysis.
Sponsors
Cardiora Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is at least 18 years of age 2. HF consistent with NYHA class II - IV 3. Subject has a known history of HF (more than 12 months in duration) and had at least 1 hospitalization for HF in the past 3 months 4. Subject has left ventricular ejection fraction (LVEF) less than 35% 5. Subject is receiving optimal medical therapy as tolerated according to the subject’s physician
Exclusion criteria
1. subject has had a myocardial infarct (MI) within 90 days before Screening 2. Subject is listed for heart transplant or a LVAD 3. Subject has a systolic blood pressure less than 90 mm Hg 4. Subject has, at Screening, significant hepatic disease (serum total bilirubin equal or more than 3.0 mg/dL [equal or more than 51.3 micromol/L), renal disease (eGFR less than 30 mL/min), or hematologic, gastrointestinal, immunologic, endocrine, metabolic, or central nervous system disease 5. Subject is symptomatically too unwell to be considered for trial, as evidenced by 6MWT less than 150m 6. Subject has undergone cardiac surgery within the 60 days before Screening 7. Symptomatic ventricular arrhythmia or ICD firing within 60 days before Screening 8. Subjects who are receiving flecainide, encainide, propafenone, dofetilide, or disopyramide 9. Subjects who have received within 7 days before the Screening or dosing visits: a. An IV positive inotropic agent b. A human B-type natriuretic peptide, including nesiritide c. An oral or IV phosphodiesterase III inhibitor (PDEI III), including levosimendan and cilostazol 10. Subjects who have the following laboratory results at screening a. Serum potassium concentration less than 4.0 or more than 5.5 mEq/L (less than 4.0 or more than 5.5 mmol/L) b. Serum magnesium concentration less than 1.0 mEq/L (less than 0.5 mmol/L) c. Serum digoxin concentration more than 1.2 ng/mL (more than 1.5 nmol/L)
Outcome results
None listed