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A Safety Evaluation of ECG Intervals and Blood Pressure in Normal Healthy Volunteers After Use of Nebivolol, Atenolol, Moxifloxacin, or Placebo

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Mylan

Status and phase

Completed
Phase 1

Conditions

Hypertension

Treatments

Drug: Moxifloxacin
Drug: Nebivolol
Drug: Atenolol

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

Nebivolol is one of a class of drugs known as beta-blockers. These drugs are useful in the treatment of high blood pressure, angina, abnormal heart rhythms and following a heart attack. The purpose of this study is to explore the potential of nebivolol to cause a certain type of abnormal heart rhythm, known as QTc prolongation. The potential of nebivolol to cause this adverse event will be compared to three other drugs: atenolol, a beta-blocker approved by the FDA; Avelox (moxifloxacin), an anti-biotic approved for use by the FDA which is known to cause QTc prolongation; and placebo, a drug look-alike that contains no drug. The working hypothesis was that 20 or 40 mg of nebivolol would not prolong corrected QT intervals measured during peak nebivolol concentrations (i.e., 2 hours after dosing) on Day 7.

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Men and nonpregnant, nonlactating women were 18 years or older.
  • Women declaring postmenopausal or surgical sterility.
  • Women of childbearing potential who had a negative serum HCG within 2 weeks of dosing.
  • Male subjects weighed at least 60 kg (132 lb), and female subjects weighed at least 48 kg (106 lb). All volunteers weighed within 15% of their ideal body weight (IBW).

Exclusion criteria

  • Institutionalized

  • Reported or was known to have done the following:

    • Used any tobacco product.
    • Ingested any alcoholic, caffeine or xanthine containing food or beverage within the 48 hours prior to the initial dose of study medication
    • Consumed grapefruit or grapefruit containing products within 7 days prior to the initial dose of study medication.
    • Ingested any vitamins or herbal products within the 48 hours prior to the initial dose of study medication.
    • Recently changed dietary or exercise habits significantly
  • Used any medication (including over-the-counter [OTC]) within the 14 days prior to the initial dose of study medication.

  • Used any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.

  • Received an investigational drug within 30 days prior to the initial dose of study medication.

  • History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease.

  • History of drug and/or alcohol abuse within 1 year prior to the study.

  • Acute illness at the time of either the pre study medical evaluation or dosing.

  • Any laboratory results deemed clinically significant by the physician.

  • Abnormal and clinically relevant ECG tracing.

  • Donated or lost a significant volume of blood or plasma (>450 mL) within 28 days prior to the initial dose of study medication.

  • Allergic or hypersensitive to nebivolol, atenolol, or other β blocking drugs or to moxifloxacin or other quinolone antibiotics.

  • History of seizures or cerebrovascular disease.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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