Phase I Interaction Study of Istaroxime and Digoxin in Subjects With Stable Heart Failure

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study explores a potential drug-drug interaction between istaroxime and digoxin in patients with stable CHF on chronic oral digoxin treatment.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Debiopharm International SA
• Treatments: Digoxin

Criteria

Inclusion Criteria:

Main screening inclusion criteria :

• Signed informed consent;

• Male or female patients ≥18 years;

• Female patients of childbearing potential must not be pregnant;

• Chronic stable cardiac function impairment (no change in heart failure medication over the last 3 months and without any dosage adjustment in the last 4 weeks);

• Systolic blood pressure (SBP) of ≥ 90 mmHg and ≤ 140 mmHg;

• LVEF ≤ 35% by any method (to be performed at screening if not measured within the last 12 months);

• Chronic treatment (i.e. once daily dosing without interruption) with oral digoxin started at least 3 months prior to study entry and without any concomitant administration of other positive inotropic drugs;

Exclusion Criteria:

Main screening exclusion criteria :

• Need for current or intermittent intravenous positive inotrope administration within the preceding 6 months, or hemodynamic support devices;

• Acute coronary syndrome within the past 3 months;

• Coronary artery bypass graft or percutaneous coronary intervention within the past 3 months;

• Stroke within the past 6 months;

• Atrial fibrillation or uncontrolled heart rate (HR) (> 100 beats per minute [bpm]);

• Significant arrhythmia or second or third degree atrio-ventricular block;

• Valvular disease as the primary cause of HF;

• Significant ECG abnormalities as assessed by appropriately qualified physician or investigator including QTcF >450;

• Positive testing for Human Immunodeficiency Virus (HIV), Hepatitis B and/or Hepatitis C;

Main randomization exclusion criteria:

• HR > 100 bpm or < 50 bpm;

• Serum potassium > 5.3 mmol/L or < 3.8 mmol/L and magnesium > 1.1 mmol/L or < 0.6 mmol/L,

• TN I > ULN.