Evaluating the Plasma Pharmacokinetics of CRD-102 in patients with Heart Failure following long term administratio

Phase 1

Completed

• Conditions: Cardiovascular - heart failure; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12616000120471
• Lead Sponsor: Cardiora Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 45

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the pharmacokinetics of CRD-102 following long term administration.<br>These parameters are assessed by blood sample, and is assesed via measuring: Trough level concentration, Cmax, Tmax, T1/2 (half life), elimination rate, AUC exposure<br>[30 days<br>PK will be analysed at pre-dose (0 hr), and at 1, 2, 3, 4, 6, 8, 10 and 12 hours following administration of CRD-102]

Secondary Outcome Measures

Name	Time	Method
To evaluate the effects of CRD-102 on NT-BNP levels (serum assay)[30 days. This will be assessed on day 30, sample to be taken pre-dose on day 30. ];To evaluate the effects of CRD-102 on renal function (blood tests - lab testing of electrolytes, urea and creatinine)[At pre-dose on day 30];To evaluate the effects of CRD-102 on 6 minute walk test[this will be done on day 30, after the administration of the morning dose of CRD-102];To evaluate the effects of CRD-102 on ICD activity. This will be done via interrogation of the ICD via an ICD interrogator, sensor that subsequently transmit all relevant information to a computing device, where a report will be generated for physician review[THis will be done on day 30, following administration of the morning dose of CRD-102]