Safety and Hemodynamic Effects and Pharmacokinetics of CXL-1020 in Patients With Stable Heart Failure

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Heart Failure

In brief

A Phase 1-2a Study of CXL-1020-01 in Patients with Stable Heart Failure

Key facts

Study ID

NCT01092325

Run by

Bristol-Myers Squibb

People needed

28

Starts

2009-06-01

Expected to finish

2010-05-01

Last updated by the study team

2016-07-01

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• In order to be eligible for randomization, a patient MUST:
• Be a male or post menopausal or surgically sterile female outpatient between 18 and 85 years of age
• Have chronic Systolic HF due to primary/idiopathic dilated cardiomyopathy, coronary artery disease or hypertension, and stable for at least 30 days prior to screening
• Have a core echo lab confirmed left ventricular ejection fraction ≤ 40% in a baseline 2D-Echocardiogram prior to and within 60 days of the first dose of study medication with evidence of at least minimal LV dilation on the basis of an observed LV-EDV index that is above normal
• Have a baseline NT-Pro-BNP of greater than or equal to the top of the normal reference range (124pg/ml) prior to and within 60 days of the first dose of study medication
• Be on unchanging doses of HF medications (with exception of diuretic dosage) for 2 weeks prior to randomization without planned initiation of new hemodynamically active therapy during the conduct of the study
• Be capable of understanding the nature of the trial and be willing to participate as documented by written informed consent
• Be willing and able to comply with the study protocol requirements for the duration of the study, including pharmacokinetic sampling
• If a post-menopausal or surgically sterile female, confirmation of sterility status (Post menopausal or surgically sterile for at least 6 months) - (Post-menopausal subjects will require a urine pregnancy test for confirmation prior to enrollment and urine pregnancy tests prior to each dosing)
• If a fertile male, must be using 2 approved contraceptive methods (a condom and a spermicidal agent, even if the partner is using birth control) for the duration of the study and for 3 months following participation in the study and further agree to not donate sperm for 3 months after participation in the study. Must have a negative urine test for drugs of abuse and a negative ethanol breath test at screening and before each dosing period
• Have required local lab data within non-exclusionary ranges before each dosing

You may not qualify if…

• In order to be eligible for randomization, a patient MUST NOT:
• Have participated in any investigational drug study within 30 days preceding randomization or have previously received therapy with CXL-1020
• Have a heart rate <50 or ≥ 90 BPM at baseline prior to randomization.
• Have a blood pressure >150 Systolic and/or >90 diastolic mmHg at baseline prior to randomization
• Have a systolic blood pressure of less than 100 mmHg at baseline prior to randomization
• Have QT/QTc prolongation > 460 msec or > 500msec in patients with preexisting bundle branch block (only applies to non-paced patients in sinus rhythm)
• Have experienced a documented symptomatic or electrocardiographically recorded episode of atrial fibrillation/flutter within 60 days before screening and be in normal sinus rhythm at each baseline before study drug is administered
• Have a history of sustained or hemodynamically significant VT or VF requiring cardioversion, or self-terminating VT associated with hypotension
• Have non-sustained VT (HR > 120 bpm) of 10 beats or more during monitoring in the baseline monitoring period prior to each dose of study medication, or in any Holter or EKG recording within 1 year of first dose of study medication.
• Have a weight or height that exceeds the specifications for the ICG Device of (greater than 341 pounds or taller than 7 feet 2 inches.)
• Be post-successful cardiac resuscitation
• Have a history of worsening HF within 30 days prior to screening as defined by:
• Unscheduled ER or clinic visits relating to HF or hospital admission for management of HF
• Treatment with intravenous inotropic or vasodilator drugs
• Be diagnosed with acute coronary syndrome or acute myocardial infarction within three months prior to screening
• Have a history of stroke (CVA) or transient ischemic attack (TIA) within six months prior to screening
• Have a history of CCS Class III or IV angina
• Be a patient whose HF etiology is attributable to either restrictive/obstructive cardiomyopathy, idiopathic hypertrophic cardiomyopathy (as defined by any wall thickness > 1.8 cm) or uncorrected severe valvular disease
• Be receiving concomitant therapy with any antiarrhythmic drugs other than amiodarone
• Have experienced the firing of an implantable ICD for documented ventricular ectopy within three months prior to screening
• Have a known allergy to the ICG Device sensor gel or adhesive
• Have unsuitable Echocardiographic Windows for the comprehensive Echo assessments required in the Echo cohorts (exclusion for echo cohorts only)
• Have a skin lesion at the site of the ICG Device sensor placement.
• Have a screening or baseline serum Na < 130 mEq/l or > 145 mEq/l; a serum K < 3.5 mEq/l or > 5.0 mEq/l; a serum Ca < 7.5 mg/dl or > 10 mg/dl; or a serum Mg < 1.6 mEq/l or > 3.0 mEq/l., or a digoxin level above 1ng/ml
• Have a screening TSH < 0.1 mcU/ml or > 5.0 mcU/ml

Where it is running

• Orange County Clinical Research Center — Tustin, California, United States

Full record on ClinicalTrials.gov

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