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Pharmacodynamic and Pharmacokinetic Study of BiDil Extended-release Capsules and Commercial BiDil Tablets

Information source: Arbor Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Heart Failure

Intervention: BiDil XR (Drug); BiDil Immediate Release (IR) (Drug)

Phase: Phase 1/Phase 2

Status: Not yet recruiting

Sponsored by: Arbor Pharmaceuticals, Inc.

Overall contact:
T D Johnson, RN, Phone: 404-496-5903, Email: tjohnson@arborpharma.com

Summary

This study will investigate cardiovascular parameters using echocardiographic and pharmacokinetics during a daily dose of BiDil and BiDil Extended Release (XR) compared to a study drug free day.

Clinical Details

Official title: Randomized, Open-Label, Daily Dose, 2-sequence, 2-way Crossover Pharmacodynamic and Pharmacokinetic Study of BiDil XR Capsules and Commercial BiDil Tablets in Self-identified Black Patients, Who Are Slow Acetylators, With Heart Failure

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Pulmonary Artery (PA) Systolic Pressure change from baseline to each post dose timepoint for 28 hours

Secondary outcome:

Comparison of Maximum observed effect (Emax) on PA systolic pressure vs maximum blood concentration (Cmax)

Comparison of the area under the effect curve (AUEC) on PA systolic pressure versus AUC (the area under the curve) for blood

Detailed description: A multiple-center, open-label, randomized, daily dose, two-sequence, two-way crossover pharmacodynamics (PD) and pharmacokinetic (PK) study of BiDil XR capsules and commercial BiDil tablets in Self-identified Black Patients, who are Slow Acetylators, with Heart Failure and have not received BiDil, isosorbide dinitrate (ISDN), or hydralazine hydrochloride (HCl) for at least 30 days prior to screening. The study consists of two doses of BiDil XR capsules (dosed at 0 hr and 9 hr) and three doses of BiDil tablets (dosed at 0 hr, 6 hr and 12 hr).

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Self-identified Black, stable, chronic heart failure male or female subjects

classified as having New York Heart Association (NYHA) Class II or III, diagnosed at least 3 months prior to Screening.

- Clinically stable outpatient, receiving standard, stable treatment regimen for heart

failure (HF), at least 2 weeks prior to screening and throughout the duration of the trial. Subjects receiving beta-blockers must have been taking these for at least 3 months.

- All other medications must have been at a stable dose for at least 2 weeks prior to

first dose

- Subjects must not have received BiDil, isosorbide dinitrate or hydralazine HCl for at

least 30 days prior to Screening

- Have an adequate and demonstrable baseline Tricuspid regurgitation jet, visible

inferior vena cava, and adequate right heart echocardiogram (with or without saline bubble contrast) allowing measurements to be made.

- Baseline PA systolic pressures > 35 mmHg

- Slow acetylator

- Adult subjects at least 18 years old or state-specific age of majority.

- Clinical lab tests negative for HIV, Hepatitis B surface antigen and Hepatitis C

antibody.

- Urine testing negative for alcohol and drugs of abuse.

- Negative human chorionic gonadotropin (hCG) pregnancy test.

- Females must agree to avoid becoming pregnant or males must agree to use appropriate

contraceptive methods with his partner(s), during the study and up to post 30 days from last dose of study drug.

- Females must be:

- unable to have children or

- where the partner is sterile OR

- willing to remain abstinent OR

- willing to use two effective methods of birth control.

- Willing and able to be confined for inpatient study periods and agree to study

restrictions

- Ability to grant voluntary informed consent to participate in the study.

Exclusion Criteria:

- Have significant valvular heart disease, hemodynamically significant obstructive

hypertrophic cardiomyopathy, active myocarditis, or uncontrolled hypertension.

- Presence of severe, clinical right heart failure.

- Symptoms of unstable angina, a myocardial infarction, cardiac surgery, or

percutaneous coronary intervention within 1 month prior to Screening

- Have coronary artery disease likely to require coronary artery bypass grafting or

percutaneous coronary intervention during the ensuing 3 months.

- Had cardiac arrest or a sustained ventricular tachycardia considered life threatening

and requiring intervention within 3 months, unless treated with implantable cardioverter-defibrillator.

- other causes of pulmonary hypertension that may confound pharmacodynamic assessments

of heart failure

- Active malignancy or any non-cardiac life-limiting disease.

- Have significant hepatic, renal, or other disease that might confound the study

results or present a risk to the subject.

- Had a stroke within the past 3 months.

- Received parenteral inotropic therapy within 1 month.

- Likelihood of undergoing cardiac transplantation or circulatory assist device implant

over the ensuing 3 months.

- Symptomatic hypotension or blood pressure less than 110/70 mmHg at Screening.

- Any condition or risk factor which would jeopardize the evaluation of efficacy or

safety or the ability to obtain effective echocardiography results.

- Currently require riociguat, hydralazine HCl, long-acting nitrates like ISDN,

isosorbide mononitrate or sustained release nitroglycerin or phosphodiesterase 5 inhibitors.

- Alcohol or drug abuse within 1 year of study participation.

- Hypersensitivity, allergy, idiosyncratic reaction or adverse reaction to caffeine (if

slow acetylator test is required), ISDN, hydralazine HCl, or any compounds with similar chemical characteristics.

- Received investigational drug within 30 days.

- Donated one pint or more of blood, plasma, or platelets within 30 days.

- Any subject who, in the opinion of the Investigator, cannot follow instructions.

- Pregnant, lactating or plan to get pregnant during the study

- History of lupus erythematous or lupus like syndrome.

- Use of herbal preparations, grapefruit, grapefruit juice, Seville oranges/juice or

use of phosphodiesterase inhibitors within 2 weeks of first dose of study drug and throughout study.

- Employee of the Sponsor, investigative site or contract research organization.

Locations and Contacts

T D Johnson, RN, Phone: 404-496-5903, Email: tjohnson@arborpharma.com

Additional Information

Starting date: September 2015
Last updated: August 11, 2015

Page last updated: August 23, 2015

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